Stroke, Traumatic Brain Injury
Conditions
Keywords
stroke, Injury, Brain, Traumatic, Family Caregivers, TBI (Traumatic Brain Injury), Informal Caregivers
Brief summary
The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also determining it's cost effectiveness in the stroke and traumatic brain injury (TBI) populations.
Detailed description
Background: Stroke and traumatic brain injury (TBI) are leading causes of long-term disability among Veterans and result in the need for care from informal caregivers in the home setting. There are very few evidence-based, easy-to-deliver follow-up programs to train Veterans and caregivers across multiple domains post injury. The Acquiring New Skills While Enhancing Remaining Strengths for Veterans (ANSWERS-VA) intervention aims to provide the Veteran and caregiver dyad with a set of practical skills that each can use in coping with and managing symptoms of a brain injury, applying a strength-based approach. Objectives: The objectives of this study are to conduct a randomized controlled trial (RCT) to evaluate (a) the efficacy of the ANSWERS-VA dyadic intervention with Veterans who have sustained a stroke and/or TBI and their informal caregivers, and (b) estimate effect sizes for the ANSWERS-VA intervention. The ANSWERS-VA intervention will be compared with an educational intervention that will serve as an attention control group. Specific Aim 1: To tailor the implementation of the ANSWERS-VA intervention to dyads of Veterans post stroke and/or TBI and their informal caregivers (n=10) and modify the implementation processes for the RCT. Specific Aim 2: To test the short-term (immediately post-intervention) and long-term, sustained (12 and 24 weeks, and at 1 year) efficacy of the ANSWERS-VA intervention for improving: (a) the primary outcomes of the caregivers' quality of life and unhealthy days, and (b) the caregiver mediators of task difficulty, threat appraisal, self-efficacy for caregiving, and optimism. Specific Aim 3: To evaluate program delivery costs for the ANSWERS-VA intervention and the educational attention control procedures, and to assess the cost-effectiveness of the ANSWERS-VA intervention in terms of noncaregiving hours and unhealthy days in caregivers of Veterans post stroke and/or TBI. Exploratory Aim 1: To estimate the effect sizes for the ANSWERS-VA intervention for the caregiver and Veteran on the secondary outcomes of depressive symptoms, social participation, and quality of the dyadic relationship. Methods: The investigators propose to conduct a RCT to evaluate the ANSWERS-VA intervention among Veterans with stroke or TBI and their caregivers (dyads). Veterans with stroke (N = 222) or TBI (N = 108) and their informal caregivers, who have received care at the Michael E. DeBakey Veterans Affairs Medical Center in Houston or the Richard L. Roudebush VAMC in Indianapolis, will be randomized to the ANSWERS-VA intervention or to an attention control group. Both the intervention and control procedures involve 8 telephone sessions delivered over 8 weeks, with a booster session at 12 weeks. Data collections will occur at baseline, 8 weeks (short-term intervention effect), 12 weeks (after booster), 24 weeks, and 1 year after baseline (long-term sustainability of intervention effect). Linear mixed models will be applied to the repeated-measures data to test efficacy of the program in stroke caregivers and to estimate effect sizes in TBI caregivers. An incremental cost-effectiveness ratio will be employed to address the comparative costs and outcomes for the ANSWERS-VA intervention and attention control groups. Status: Essential modifications for this project were requested and approved via VA Central Office. Institutional Review Board approval has been obtained for these modifications in Indianapolis and in Houston. Graduate students from multiple disciplines have been hired and have received two days of onsite training specific to the ANSWERS-VA intervention and control procedures, screening, recruitment, and data collection processes. The REDCap database has been updated for the project modifications and has been further tested. The investigators are currently working with frontline providers at both sites to recruit potential participants for this RCT. Enrollment of first subject dyads began November, 2014. At this time, the investigators have completed recruitment of new dyads. We continue to complete outcomes assessments on some dyads. We plan to submit an abstract to the International Stroke Conference in January 2019.
Interventions
BEHAVIORALANSWERS - Acquiring New Skills While Enhancing Remaining Strengths
Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and TBI.
OTHERControl
8 week telephone usual care with education with nurse case manager
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informal caregiver of a family member or friend (Veteran) with a stroke or TBI * Caregiver must express need or concerns in providing care * Plans to be providing care for 1 year or longer * Access to telephone * Willingness to participate in 9 call from a nurse and 5 data collection calls at designated timepoints * Veteran's stroke must be within past 3 years * Veteran's TBI must be since 9/11/01
Exclusion criteria
* Caregiver or survivor age \< 18 years * Caregiver denies that survivor has had a stroke or a TBI * Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke or TBI * Caregiver has low task difficulty (OCBS task difficulty score \< 16) * Caregiver communication difficulties (e.g., hearing loss) * Caregiver not fluent in the English language * Caregiver with serious medical illness limiting ability to participate * Caregiver refuses to sign a HIPAA authorization allowing the VA to store personal health information (PHI) in a location outside the VA * Survivor residing in a nursing home or long-term care facility * Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis) * Survivor or caregiver history of hospitalization for alcohol or drug abuse * Survivor or caregiver history of Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, or schizophrenia. * Survivor or caregiver pregnancy * Survivor or caregiver is a prisoner or on house arrest * Survivor had a Transient Ischemic Attack (rather than a hemorrhagic or ischemic stroke) * Survivor had a stroke more than 3 years ago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | Baseline, Week 12, 6 months and 1 year | Depression scores are measured with the PHQ9 scale. Scores can range from 0 to 27, with higher scores indicating higher levels of depression. |
| Mediators of Caregiver's Task Difficulty | Baseline, Week 12, 6 months and 1 year | Task difficulty is measured with the Oberst Caregiving Burden Scale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating higher levels of burden. |
| Mediators of Caregiver's Optimism Scale | Baseline, Week 12, 6 months and 1 year | Optimism is measured with the Life Orientation Test-Revised Scale. Scores can range from 0 to 40 with higher scores indicating more optimism. |
| Mediators of Caregiver's Threat Appraisal Scale | Baseline, Week 12, 6 months and 1 year | Threat appraisal is measured with the Appraisal of Caregiving Scale: Threat Subscale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating less belief, feelings and ability to take care of a loved one with stroke or brain injury in the future. |
Countries
United States
Participant flow
Recruitment details
The number of recruited participants (143) is slightly different from the number of participants represented in the flow diagram (137) due to the fact there were 6 participants after recruitment and informed consent we were not able to reach them for data collection.
Pre-assignment details
Veterans and Caregiver were enrolled as dyads. Participants refers to the Dyads.
Participants by arm
| Arm | Count |
|---|---|
| ANSWERS-VA 8 week telephone intervention with nurse case manager using Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS)
ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and TBI. | 67 |
| Control 8 week telephone usual care with education with nurse case manager
Control: 8 week telephone usual care with education with nurse case manager | 63 |
| Total | 130 |
Baseline characteristics
| Characteristic | Total | ANSWERS-VA | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 10 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 57 Participants | 50 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 118 Participants | 61 Participants | 57 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 63 |
| other Total, other adverse events | 2 / 67 | 0 / 63 |
| serious Total, serious adverse events | 0 / 67 | 0 / 63 |
Outcome results
Primary
Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale
Depression scores are measured with the PHQ9 scale. Scores can range from 0 to 27, with higher scores indicating higher levels of depression.
Time frame: Baseline, Week 12, 6 months and 1 year
Population: Not change data. One Intervention Caregiver and one Control Caregiver did not complete the PHQ9. Those data are missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANSWERS-VA | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | Baseline | .56 score on a scale | Standard Deviation 0.53 |
| ANSWERS-VA | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | Week 12 | .41 score on a scale | Standard Deviation 0.45 |
| ANSWERS-VA | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | 6 Months | .20 score on a scale | Standard Deviation 0.25 |
| ANSWERS-VA | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | 1 Year | .47 score on a scale | Standard Deviation 0.66 |
| Control | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | 1 Year | .43 score on a scale | Standard Deviation 0.49 |
| Control | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | Baseline | .68 score on a scale | Standard Deviation 0.61 |
| Control | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | 6 Months | .57 score on a scale | Standard Deviation 0.56 |
| Control | Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale | Week 12 | .62 score on a scale | Standard Deviation 0.59 |
Comparison: 12 weeks compared to Baseline (BL)p-value: 0.8407Mixed Models Analysis
Comparison: At 6 months compared to BLp-value: 0.015Mixed Models Analysis
Comparison: 1 year compared BLp-value: 0.8373Mixed Models Analysis
Primary
Mediators of Caregiver's Optimism Scale
Optimism is measured with the Life Orientation Test-Revised Scale. Scores can range from 0 to 40 with higher scores indicating more optimism.
Time frame: Baseline, Week 12, 6 months and 1 year
Population: Not change data. One Control Caregiver did not complete the Life Orientation Test-Revised Scale. Those data are missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANSWERS-VA | Mediators of Caregiver's Optimism Scale | 6 Months | 2.31 score on a scale | Standard Deviation 0.34 |
| ANSWERS-VA | Mediators of Caregiver's Optimism Scale | Baseline | 2.29 score on a scale | Standard Deviation 0.35 |
| ANSWERS-VA | Mediators of Caregiver's Optimism Scale | 1 Year | 2.25 score on a scale | Standard Deviation 0.27 |
| ANSWERS-VA | Mediators of Caregiver's Optimism Scale | 12 Week | 2.19 score on a scale | Standard Deviation 0.4 |
| Control | Mediators of Caregiver's Optimism Scale | 1 Year | 2.28 score on a scale | Standard Deviation 0.37 |
| Control | Mediators of Caregiver's Optimism Scale | Baseline | 2.33 score on a scale | Standard Deviation 0.39 |
| Control | Mediators of Caregiver's Optimism Scale | 6 Months | 2.29 score on a scale | Standard Deviation 0.31 |
| Control | Mediators of Caregiver's Optimism Scale | 12 Week | 2.29 score on a scale | Standard Deviation 0.27 |
Comparison: 12 weeks compared to BLp-value: 0.1918Mixed Models Analysis
Comparison: 6 months compared to BLp-value: 0.9212Mixed Models Analysis
Comparison: 1 year compared to BLp-value: 0.2358Mixed Models Analysis
Primary
Mediators of Caregiver's Task Difficulty
Task difficulty is measured with the Oberst Caregiving Burden Scale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating higher levels of burden.
Time frame: Baseline, Week 12, 6 months and 1 year
Population: Not change data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANSWERS-VA | Mediators of Caregiver's Task Difficulty | Baseline | 1.99 score on a scale | Standard Deviation 0.77 |
| ANSWERS-VA | Mediators of Caregiver's Task Difficulty | 12 Week | 1.73 score on a scale | Standard Deviation 0.7 |
| ANSWERS-VA | Mediators of Caregiver's Task Difficulty | 6 Months | 1.70 score on a scale | Standard Deviation 0.64 |
| ANSWERS-VA | Mediators of Caregiver's Task Difficulty | 1 Year | 1.78 score on a scale | Standard Deviation 0.62 |
| Control | Mediators of Caregiver's Task Difficulty | 1 Year | 1.66 score on a scale | Standard Deviation 0.79 |
| Control | Mediators of Caregiver's Task Difficulty | Baseline | 1.83 score on a scale | Standard Deviation 0.68 |
| Control | Mediators of Caregiver's Task Difficulty | 6 Months | 1.63 score on a scale | Standard Deviation 0.57 |
| Control | Mediators of Caregiver's Task Difficulty | 12 Week | 1.73 score on a scale | Standard Deviation 0.61 |
Comparison: 12 weeks compared to BLp-value: 0.6445Mixed Models Analysis
Comparison: 6 months compared to BLp-value: 0.5247Mixed Models Analysis
Comparison: 1 year compared to BLp-value: 0.9974Mixed Models Analysis
Primary
Mediators of Caregiver's Threat Appraisal Scale
Threat appraisal is measured with the Appraisal of Caregiving Scale: Threat Subscale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating less belief, feelings and ability to take care of a loved one with stroke or brain injury in the future.
Time frame: Baseline, Week 12, 6 months and 1 year
Population: Not change data. One Control Caregivers did not complete the Threat Subscale. Those data are missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ANSWERS-VA | Mediators of Caregiver's Threat Appraisal Scale | Baseline | 2.73 score on a scale | Standard Deviation 0.86 |
| ANSWERS-VA | Mediators of Caregiver's Threat Appraisal Scale | 12 Week | 2.56 score on a scale | Standard Deviation 0.83 |
| ANSWERS-VA | Mediators of Caregiver's Threat Appraisal Scale | 6 Months | 2.38 score on a scale | Standard Deviation 0.95 |
| ANSWERS-VA | Mediators of Caregiver's Threat Appraisal Scale | 1 Year | 2.58 score on a scale | Standard Deviation 1 |
| Control | Mediators of Caregiver's Threat Appraisal Scale | 1 Year | 2.44 score on a scale | Standard Deviation 0.61 |
| Control | Mediators of Caregiver's Threat Appraisal Scale | Baseline | 2.66 score on a scale | Standard Deviation 0.78 |
| Control | Mediators of Caregiver's Threat Appraisal Scale | 6 Months | 2.69 score on a scale | Standard Deviation 0.67 |
| Control | Mediators of Caregiver's Threat Appraisal Scale | 12 Week | 2.49 score on a scale | Standard Deviation 0.68 |
Comparison: 12 weeks compared to BLp-value: 0.1107Mixed Models Analysis
Comparison: 6 months compared to BLp-value: 0.0562Mixed Models Analysis
Comparison: 1 year compared to BLp-value: 0.8579Mixed Models Analysis