Depression
Conditions
Keywords
Depression, Burden, Problem Solving Ability, Caregivers, Stroke, Veterans
Brief summary
This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.
Detailed description
This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention. The investigators will conduct a two-arm (8-session intervention vs. standard care), , randomized controlled trial to test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. A sample of 290 stroke caregivers will be randomly assigned to either an intervention or a standard care group. Eligibility criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group. We will determine caregiver status. Baseline measurements will be conducted with the caregivers prior to the intervention. Post-test assessments will be collected at 1 and 12 weeks post-intervention. In addition, the investigators will obtain pre- and post-test measures of Veteran-related variables via Computerized Patient Record System (CPRS) electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention. A general linear mixed model for repeated measures will be used to examine the relationship between treatment assignment and each outcome over time. The investigators will measure the budgetary impact of providing intervention by comparing the costs of the intervention group to the costs of the control group.
Interventions
OTHERRESCUE Problem Solving Intervention
The RESCUE Problem Solving Intervention: This is an education and support intervention for caregivers of Veterans with stroke. The investigators taught study participants the COPE (Creativity, Optimism, Planning, Expert Advice) model of problem solving and guided them through the application of this model in their caregiver role. They also receive tailored stroke education, specific to their needs.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The PI and data collectors will be blinded in this study.
Intervention model description
A two-arm (8-session intervention vs. standard care), randomized controlled clinical trial with three assessment points will be conducted. Baseline measurements will be conducted with the caregivers prior to the intervention. Post-test assessments will be collected at 1 and 12 weeks post-intervention. In addition, the investigators will obtain pre- and post-test measures of Veteran-related variables via CPRS electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group. Random assignment to the intervention or standard care group. The investigators will determine caregiver status.
Exclusion criteria
The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria or are managing end-of-life issues (stroke survivors are likely to die within five months following discharge).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Depression at 9 Weeks | 9 weeks after baseline | Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity. |
| Change in Caregiver Depression at 21 Weeks | 21 weeks after baseline | Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks | 21 weeks | Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks | 9 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks | 21 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks | 9 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks | 21 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks | 9 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks | 21 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Change in Caregiver Burden-Zarit - 9 Weeks | 9 weeks | Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden. |
| Change in Caregiver Burden-Zarit - 21 Weeks | 21 weeks | Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden. |
| Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks | 9 weeks | Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability. |
| Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks | 21 weeks | Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability. |
| Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks | 9 weeks | Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability. |
| Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks | 21 weeks | Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability. |
| Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks | 9 weeks | Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability. |
| Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks | 21 weeks | Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability. |
| Change in Veteran's Functional Abilities- 9 Weeks | 9 weeks | Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes. |
| Change in Veteran's Functional Abilities- 21 Weeks | 21 weeks | Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes. |
| Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks | 9 weeks | Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12. |
| Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks | 9 weeks | Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12. |
| Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks | 21 weeks | Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks | 9 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks | 21 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks | 9 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks | 21 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks | 9 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
| Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks | 21 weeks | The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 21 Weeks | 21 weeks | Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies. |
| Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 9 Weeks | 9 weeks | Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies. |
| Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 21 Weeks | 21 weeks | Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies. |
| Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 9 Weeks | 9 weeks | Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies. |
| Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 21 Weeks | 21 weeks | Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies. |
| Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 9 Weeks | 9 weeks | Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Group The standard care group will receive the usual standard care they would receive had they not been enrolled in this study. | 105 |
| Intervention Group Participants in the intervention group received an 8-week problem-solving session conducted over the phone by a trainer interventionist. The intervention consists of four components: 1. Introduction to the RESCUE website and the problem-solving method; 2. Illustrative example on how to use the problem-solving approach and the RESCUE website to address caregiving problems; 3. Individualized practice exercise to develop a personalized problem-solving plan; and 4. Summary of the problem-solving method.
The RESCUE Problem Solving Intervention: This is an education and support intervention for caregivers of Veterans with stroke. The investigators taught study participants the COPE (Creativity, Optimism, Planning, Expert Advice) model of problem solving and guided them through the application of this model in their caregiver role. They also receive tailored stroke education, specific to their needs. | 105 |
| Total | 210 |
Baseline characteristics
| Characteristic | Standard Care Group | Intervention Group | Total |
|---|---|---|---|
| Age, Customized 18 years or older | 105 Participants | 105 Participants | 210 Participants |
| Caregiver- Education College Degree | 43 Participants | 29 Participants | 72 Participants |
| Caregiver- Education Doctoral Degree | 3 Participants | 3 Participants | 6 Participants |
| Caregiver- Education High School Graduate | 11 Participants | 17 Participants | 28 Participants |
| Caregiver- Education Masters Degree | 14 Participants | 10 Participants | 24 Participants |
| Caregiver- Education Not Answered | 1 Participants | 0 Participants | 1 Participants |
| Caregiver- Education Some College/Vocational | 28 Participants | 39 Participants | 67 Participants |
| Caregiver- Education Some High School | 5 Participants | 7 Participants | 12 Participants |
| Caregiver- Employment Full-Time | 27 Participants | 15 Participants | 42 Participants |
| Caregiver- Employment Part-Time | 8 Participants | 10 Participants | 18 Participants |
| Caregiver- Employment Retired | 36 Participants | 43 Participants | 79 Participants |
| Caregiver- Employment Unemployed | 33 Participants | 35 Participants | 68 Participants |
| Caregiver- Employment Unknown | 1 Participants | 2 Participants | 3 Participants |
| Caregiver- Income $10,000 - $20,000 per year | 24 Participants | 36 Participants | 60 Participants |
| Caregiver- Income < $10,000 per year | 11 Participants | 10 Participants | 21 Participants |
| Caregiver- Income $20,001 - $30,000 per year | 18 Participants | 19 Participants | 37 Participants |
| Caregiver- Income $30,001 - $40,000 per year | 14 Participants | 10 Participants | 24 Participants |
| Caregiver- Income $40,001 - $50,000 per year | 16 Participants | 14 Participants | 30 Participants |
| Caregiver- Income > $50,000 per year | 20 Participants | 14 Participants | 34 Participants |
| Caregiver- Income Unknown | 2 Participants | 2 Participants | 4 Participants |
| Caregiver- Marital Status Divorced or Separated | 11 Participants | 13 Participants | 24 Participants |
| Caregiver- Marital Status Living Together with Partner | 8 Participants | 6 Participants | 14 Participants |
| Caregiver- Marital Status Married | 74 Participants | 62 Participants | 136 Participants |
| Caregiver- Marital Status Single | 11 Participants | 22 Participants | 33 Participants |
| Caregiver- Marital Status Unknown | 0 Participants | 1 Participants | 1 Participants |
| Caregiver- Marital Status Widowed | 1 Participants | 1 Participants | 2 Participants |
| Caregiver- Relationship to Veteran Child | 35 Participants | 35 Participants | 70 Participants |
| Caregiver- Relationship to Veteran Other Family Member | 7 Participants | 8 Participants | 15 Participants |
| Caregiver- Relationship to Veteran Other Type of Relationship | 3 Participants | 4 Participants | 7 Participants |
| Caregiver- Relationship to Veteran Parent | 1 Participants | 1 Participants | 2 Participants |
| Caregiver- Relationship to Veteran Partner | 5 Participants | 6 Participants | 11 Participants |
| Caregiver- Relationship to Veteran Sibling | 2 Participants | 7 Participants | 9 Participants |
| Caregiver- Relationship to Veteran Spouse | 52 Participants | 44 Participants | 96 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 13 Participants | 18 Participants |
| Race/Ethnicity, Customized Multi-Racial | 34 Participants | 27 Participants | 61 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Pacific Island Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 51 Participants | 101 Participants |
| Sex: Female, Male Female | 93 Participants | 92 Participants | 185 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 0 / 105 | 0 / 105 |
| serious Total, serious adverse events | 0 / 105 | 0 / 105 |
Outcome results
Primary
Change in Caregiver Depression at 21 Weeks
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
Time frame: 21 weeks after baseline
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Caregiver Depression at 21 Weeks | 14.3 score on a scale | Standard Deviation 7.7 |
| Intervention Group | Change in Caregiver Depression at 21 Weeks | 10.5 score on a scale | Standard Deviation 6 |
p-value: 0.017Mixed Models Analysis
Primary
Change in Caregiver Depression at 9 Weeks
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
Time frame: 9 weeks after baseline
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Caregiver Depression at 9 Weeks | 15.0 score on a scale | Standard Deviation 6.5 |
| Intervention Group | Change in Caregiver Depression at 9 Weeks | 10.2 score on a scale | Standard Deviation 5.4 |
p-value: 0.001Mixed Models Analysis
Secondary
Change in Caregiver Burden-Zarit - 21 Weeks
Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Caregiver Burden-Zarit - 21 Weeks | 30.8 score on a scale | Standard Deviation 6.7 |
| Intervention Group | Change in Caregiver Burden-Zarit - 21 Weeks | 23.2 score on a scale | Standard Deviation 7 |
p-value: 0.002Mixed Models Analysis
Secondary
Change in Caregiver Burden-Zarit - 9 Weeks
Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Caregiver Burden-Zarit - 9 Weeks | 30.3 score on a scale | Standard Deviation 5.9 |
| Intervention Group | Change in Caregiver Burden-Zarit - 9 Weeks | 24.5 score on a scale | Standard Deviation 6.6 |
p-value: 0.017Mixed Models Analysis
Secondary
Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks
Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks | 41.0 score on a scale | Standard Deviation 17.3 |
| Intervention Group | Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks | 57.2 score on a scale | Standard Deviation 21.4 |
p-value: 0.008Mixed Models Analysis
Secondary
Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks
Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks | 45.6 score on a scale | Standard Deviation 18.2 |
| Intervention Group | Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks | 54.2 score on a scale | Standard Deviation 18.9 |
p-value: 0.152Mixed Models Analysis
Secondary
Change in Veteran's Functional Abilities- 21 Weeks
Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Veteran's Functional Abilities- 21 Weeks | 43.3 score on a scale | Standard Deviation 7.8 |
| Intervention Group | Change in Veteran's Functional Abilities- 21 Weeks | 51.7 score on a scale | Standard Deviation 9.3 |
p-value: 0.066Mixed Models Analysis
Secondary
Change in Veteran's Functional Abilities- 9 Weeks
Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Change in Veteran's Functional Abilities- 9 Weeks | 43.8 score on a scale | Standard Deviation 6 |
| Intervention Group | Change in Veteran's Functional Abilities- 9 Weeks | 51.6 score on a scale | Standard Deviation 8.3 |
p-value: 0.067Mixed Models Analysis
Secondary
Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks | 44.4 T-score | Standard Deviation 6.5 |
| Intervention Group | Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks | 48.4 T-score | Standard Deviation 6 |
p-value: 0.052Mixed Models Analysis
Secondary
Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks | 43.8 T-score | Standard Deviation 6.7 |
| Intervention Group | Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks | 49.9 T-score | Standard Deviation 6.1 |
p-value: 0.002Mixed Models Analysis
Secondary
Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks | 40.3 T-score | Standard Deviation 5.5 |
| Intervention Group | Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks | 41.2 T-score | Standard Deviation 5.9 |
p-value: 0.138Mixed Models Analysis
Secondary
Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks | 41.8 T-score | Standard Deviation 6.1 |
| Intervention Group | Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks | 42.8 T-score | Standard Deviation 5.9 |
p-value: 0.225Mixed Models Analysis
Secondary
Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks
Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks | 79.9 score on a scale | Standard Deviation 10.6 |
| Intervention Group | Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks | 84.9 score on a scale | Standard Deviation 10.6 |
p-value: 0.229Mixed Models Analysis
Secondary
Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks
Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks | 82.2 score on a scale | Standard Deviation 9 |
| Intervention Group | Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks | 84.8 score on a scale | Standard Deviation 10.8 |
p-value: 0.812Mixed Models Analysis
Secondary
Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks
Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks | 78.6 score on a scale | Standard Deviation 9.2 |
| Intervention Group | Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks | 86.6 score on a scale | Standard Deviation 11.1 |
p-value: 0.196Mixed Models Analysis
Secondary
Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks
Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks | 81.2 score on a scale | Standard Deviation 11.1 |
| Intervention Group | Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks | 80.2 score on a scale | Standard Deviation 11.1 |
p-value: 0.968Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks | 87.4 score on a scale | Standard Deviation 9.1 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks | 86.9 score on a scale | Standard Deviation 7.9 |
p-value: 0.315Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks | 88.6 score on a scale | Standard Deviation 7.8 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks | 87.7 score on a scale | Standard Deviation 7.6 |
p-value: 0.187Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks | 91.7 score on a scale | Standard Deviation 9 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks | 92.4 score on a scale | Standard Deviation 7.5 |
p-value: 0.457Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks | 91.5 score on a scale | Standard Deviation 9.1 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks | 92.4 score on a scale | Standard Deviation 7.6 |
p-value: 0.408Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks | 92.5 score on a scale | Standard Deviation 8.1 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks | 90.6 score on a scale | Standard Deviation 7.7 |
p-value: 0.103Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks | 93.2 score on a scale | Standard Deviation 7.6 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks | 92.1 score on a scale | Standard Deviation 5.5 |
p-value: 0.159Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks | 98.2 score on a scale | Standard Deviation 10.4 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks | 100.1 score on a scale | Standard Deviation 10.7 |
p-value: 0.221Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks | 99.5 score on a scale | Standard Deviation 10.3 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks | 98.0 score on a scale | Standard Deviation 8.7 |
p-value: 0.981Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks | 107.5 score on a scale | Standard Deviation 6 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks | 109.9 score on a scale | Standard Deviation 6.4 |
p-value: 0.055Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks | 107.7 score on a scale | Standard Deviation 5.6 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks | 108.7 score on a scale | Standard Deviation 5.7 |
p-value: 0.289Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks | 100.5 score on a scale | Standard Deviation 9.2 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks | 104.9 score on a scale | Standard Deviation 10.2 |
p-value: 0.174Mixed Models Analysis
Secondary
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks | 101.2 score on a scale | Standard Deviation 9.5 |
| Intervention Group | Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks | 105.0 score on a scale | Standard Deviation 9.1 |
p-value: 0.247Mixed Models Analysis
Other Pre-specified
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 21 Weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 21 Weeks | 11 Participants |
| Intervention Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 21 Weeks | 11 Participants |
p-value: 0.6Chi-squared
Other Pre-specified
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 9 Weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 9 Weeks | 9 Participants |
| Intervention Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 9 Weeks | 14 Participants |
p-value: 0.095Chi-squared
Other Pre-specified
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 21 Weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 21 Weeks | 30 Participants |
| Intervention Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 21 Weeks | 25 Participants |
p-value: 0.9Chi-squared
Other Pre-specified
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 9 Weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 9 Weeks | 28 Participants |
| Intervention Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 9 Weeks | 33 Participants |
p-value: 0.063Chi-squared
Other Pre-specified
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 21 Weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 21 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 21 Weeks | 13 Participants |
| Intervention Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 21 Weeks | 18 Participants |
p-value: 0.11Chi-squared
Other Pre-specified
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 9 Weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 9 weeks
Population: Data collected from 156 participants who completed the study. Data from caregivers who ended up not meeting study criteria were not included in the analysis of data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 9 Weeks | 10 Participants |
| Intervention Group | Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 9 Weeks | 14 Participants |
p-value: 0.15Chi-squared