Caregivers, Chronic Illnesses, Multiple, Parents, Self-Management
Conditions
Keywords
Mental Health, Physical Health, Technology-Dependent Children
Brief summary
Parent caregivers of children with chronic conditions who require life-saving technology such as mechanical ventilation or feeding tubes must maintain a high level of vigilance 24 hours a day, 7 days a week. They usually provide a majority of their children's care and are often overwhelmed by the caregiving demands thus neglect health promotion behaviors that result in a deterioration of their own mental and physical health. The goal of this study is to test a cognitive-behavioral resourcefulness intervention that will improve these caregivers' mental and physical health and health promotion behaviors while they continue to provide vital care for these vulnerable children.
Detailed description
Parent caregivers of children who require life-saving technology such as mechanical ventilation or feeding tubes must maintain a high level of vigilance 24 hours a day, 7 days a week. They report greater levels of stress, compromised self-management behaviors and poorer psychological and physical health than other caregiver groups which dramatically increases their mortality risk. Technology-dependent children (approximately 600,000) are among the sickest and most vulnerable subset of children with complex chronic conditions in the United States. They comprise 20% of all children discharged from the hospital to home, yet account for 61% of healthcare spending for children, up to $110 billion annually. Despite the adverse consequences for caregivers, there are no interventions to meet their specific needs. Resourcefulness Training, (cognitive-behavioral self-management intervention) has been shown to improve psychological and physical outcomes, mediate the effects of stress, and enhance the care provided to care-recipients. A Resourcefulness Training Intervention (RTI) will be tested in a randomized trial against an attention control group. The RTI includes face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills, ongoing web access to the RTI video and video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life, 4 weeks of skills' reinforcement using daily log, weekly phone calls for the first 4 weeks, and booster sessions at 2 and 4 months post enrollment. The Attention Control group will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care. The aims of the study are to: 1) Determine whether the RTI versus Attention Control improves psychological (mental HRQoL depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (physical HRQoL, chronic stress \[hair cortisol\]) over 9 months in parents of technology-dependent children, after controlling for covariates (parent race/ethnicity and gender, family income, and children's functional status, type of technology). 2) Determine whether changes in psychological and physical outcomes are mediated by changes in parents' levels of resourcefulness based on intervention condition. 3) Compare self-management behavior (sleep, positive health practices) over 9 months in parents who received RTI versus Attention Control. 4) Explore whether resourcefulness is a mediator between intervention condition and self-management behaviors controlling for baseline self-management behavior over 9 months. 5) Explore the relationship between self-management behavior and parent psychological and physical outcomes based on intervention condition. Our study will be the first to test a cognitive-behavioral RTI for this caregiver population. 6) Compare target children's ER visits, hospital days over 9 months based on parent intervention condition. If shown to be efficacious, it can be replicated with other caregivers of children with complex chronic conditions with strong potential for translation into practice.
Interventions
BEHAVIORALResourcefulness Training©
The intervention includes self-help and help-seeking skills.
Sponsors
National Institute of Nursing Research (NINR)
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Data collectors and participants will be blinded to group assignment.
Intervention model description
The proposed study is a longitudinal (9-month) randomized controlled trial (RCT) in which primary caregiver parents of technology-dependent children will be randomly assigned to one of two study arms: (1) The Attention Control arm and (2) The Resourcefulness Training(c) arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* parent primary caregiver (biological, adoptive, or foster mother, father, grandmother, or grandfather) for a technology-dependent child based on the Office of Technology Assessment (OTA) classification criteria (Group 1, mechanical ventilators; Group 2, intravenous nutrition/medication; Group 3, respiratory or nutritional support); * at least 18 years of age; * able to speak and understand English; * the technology-dependent child must be age 17.2 years or younger and receive care in the home from his/her parent. For children with more than one type of technology, we will follow OTA guidelines for classification.
Exclusion criteria
\- Parents of children with a cancer diagnosis due to the short term use of technology following initial diagnosis and treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline | Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symptoms Patient Reported Outcomes Measurement Information System (PROMIS)Short Form Version 1.0 - Depression 8a. Assess self-reported negative mood , views of self , social cognition, and decreased positive affect and engagement. Eight (8) Items. Score Range: 5 (Min)-40 (Max). Total Score is reported. The score is converted to a T-Score metric. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept (depression) being measured thus a T-score of 60 is one standard deviation worse related to the concept of depression than average. |
| Self-Management- Sleep- Subjective | Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline | Appraised Sleep Quality (Pittsburgh Sleep Quality Index), Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI). Assesses sleep quality and disturbances over a l-month time interval. Nineteen (19) items are grouped into seven component scores, each weighted equally on a 0-3 scale. Score Range (Global PSQI Score) is 0-21. Higher scores indicate worse sleep quality. Sub Scales are summed |
| Positive Health Practices | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline | Personal Lifestyle Questionnaire- Positive Health Practices Personal Lifestyle Questionnaire (PLQ). Measures the positive health practices of exercise, substance use, nutrition, relaxation, safety, and health promotion. Twenty-four (24) items 4-point summated rating scale with a range of possible scores from 24 to 96 Higher scores reflect the practice of more health behaviors. Total scores are reported. |
| Psychological Outcome- Health Related Quality of Life | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline | Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health. |
| Depressive Cognitions | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline | Screening Measure for Early Detection of Depressive Symptoms: The Depressive Cognition Scale. Measures depressive cognitions and negative thoughts that may lead to clinical depression. Eight (8) Items. Score Range: 0 - 40. Higher scores indicating more depressive cognitions. |
| Physical Outcome | Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline | (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Physical Health (GPH) score converted to a T-Score metric - produces a physical health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Higher T-score means better physical health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Technology-Dependent Children With Rehospitalizations | Up to 9 months | Number of Technology-Dependent Children with Rehospitalizations over the time period the parent was enrolled and participating in the study from review of the children's charts. |
| Number of Technology-Dependent Children With ER Visits | Up to 9 months | Number of Technology-Dependent Children with ER Visits over the time period the parent was enrolled and participating in the study from review of the children's charts. |
Countries
United States
Participant flow
Pre-assignment details
There were 5 participants who signed the consent form but did not complete the baseline surveys and therefore they were not randomized and therefore not analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Attention Control The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns | 97 |
| Resourcefulness Training Intervention© The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: The intervention includes self-help and help-seeking skills. | 100 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 15 |
| Overall Study | Parent no longer eligible- child not living at home | 0 | 2 |
| Overall Study | Unable to contact to complete the intervention. | 0 | 9 |
| Overall Study | Withdrawal by Subject | 10 | 12 |
Baseline characteristics
| Characteristic | Attention Control | Resourcefulness Training Intervention© | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 97 Participants | 192 Participants |
| Age, Continuous | 37.5 years STANDARD_DEVIATION 9.58 | 35.9 years STANDARD_DEVIATION 10.7 | 36.7 years STANDARD_DEVIATION 10.2 |
| Duration of Caregiving for Technology-Dependent Child | 43.3 months STANDARD_DEVIATION 52.2 | 49.5 months STANDARD_DEVIATION 47.4 | 46.3 months STANDARD_DEVIATION 49.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 93 Participants | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 16 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 71 Participants | 77 Participants | 148 Participants |
| Region of Enrollment United States | 97 participants | 100 participants | 197 participants |
| Sex: Female, Male Female | 91 Participants | 88 Participants | 179 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 100 |
| other Total, other adverse events | 0 / 97 | 0 / 100 |
| serious Total, serious adverse events | 0 / 97 | 0 / 100 |
Outcome results
Primary
Depressive Cognitions
Screening Measure for Early Detection of Depressive Symptoms: The Depressive Cognition Scale. Measures depressive cognitions and negative thoughts that may lead to clinical depression. Eight (8) Items. Score Range: 0 - 40. Higher scores indicating more depressive cognitions.
Time frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Population: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Depressive Cognitions | 9 months- Time 5 | 6.24 score on a scale | Standard Deviation 6.06 |
| Attention Control | Depressive Cognitions | Baseline- Time 1 | 6.31 score on a scale | Standard Deviation 5.09 |
| Attention Control | Depressive Cognitions | 6 weeks- Time 2 | 6.93 score on a scale | Standard Deviation 5.73 |
| Attention Control | Depressive Cognitions | 3 months- Time 3 | 6.13 score on a scale | Standard Deviation 2.08 |
| Attention Control | Depressive Cognitions | 6 months- Time 4 | 5.84 score on a scale | Standard Deviation 5.78 |
| Resourcefulness Training Intervention© | Depressive Cognitions | 6 months- Time 4 | 8.20 score on a scale | Standard Deviation 7.32 |
| Resourcefulness Training Intervention© | Depressive Cognitions | 3 months- Time 3 | 8.17 score on a scale | Standard Deviation 6.56 |
| Resourcefulness Training Intervention© | Depressive Cognitions | Baseline- Time 1 | 8.27 score on a scale | Standard Deviation 6.63 |
| Resourcefulness Training Intervention© | Depressive Cognitions | 9 months- Time 5 | 6.69 score on a scale | Standard Deviation 6.1 |
| Resourcefulness Training Intervention© | Depressive Cognitions | 6 weeks- Time 2 | 8.62 score on a scale | Standard Deviation 6.27 |
p-value: <0.05Mixed Models Analysis
Primary
Depressive Symptoms
Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symptoms Patient Reported Outcomes Measurement Information System (PROMIS)Short Form Version 1.0 - Depression 8a. Assess self-reported negative mood , views of self , social cognition, and decreased positive affect and engagement. Eight (8) Items. Score Range: 5 (Min)-40 (Max). Total Score is reported. The score is converted to a T-Score metric. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept (depression) being measured thus a T-score of 60 is one standard deviation worse related to the concept of depression than average.
Time frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Population: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Depressive Symptoms | Baseline- Time 1 | 51.80 score on a scale | Standard Deviation 7.56 |
| Attention Control | Depressive Symptoms | 6 months- Time 4 | 50.20 score on a scale | Standard Deviation 8.45 |
| Attention Control | Depressive Symptoms | 3 months- Time 3 | 50.10 score on a scale | Standard Deviation 8.3 |
| Attention Control | Depressive Symptoms | 9 months- Time 5 | 49.90 score on a scale | Standard Deviation 8.74 |
| Attention Control | Depressive Symptoms | 6 weeks- Time 2 | 51.00 score on a scale | Standard Deviation 7.53 |
| Resourcefulness Training Intervention© | Depressive Symptoms | 9 months- Time 5 | 50.80 score on a scale | Standard Deviation 7.86 |
| Resourcefulness Training Intervention© | Depressive Symptoms | Baseline- Time 1 | 55.10 score on a scale | Standard Deviation 7.87 |
| Resourcefulness Training Intervention© | Depressive Symptoms | 6 weeks- Time 2 | 53.10 score on a scale | Standard Deviation 8.36 |
| Resourcefulness Training Intervention© | Depressive Symptoms | 3 months- Time 3 | 52.20 score on a scale | Standard Deviation 8.11 |
| Resourcefulness Training Intervention© | Depressive Symptoms | 6 months- Time 4 | 50.90 score on a scale | Standard Deviation 9.05 |
p-value: <0.05Mixed Models Analysis
Primary
Physical Outcome
(The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Physical Health (GPH) score converted to a T-Score metric - produces a physical health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Higher T-score means better physical health.
Time frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Population: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Physical Outcome | 9 months- Time 5 | 46.00 score on a scale | Standard Deviation 7.23 |
| Attention Control | Physical Outcome | Baseline- Time 1 | 44.90 score on a scale | Standard Deviation 7.58 |
| Attention Control | Physical Outcome | 6 weeks- Time 2 | 46.00 score on a scale | Standard Deviation 7.22 |
| Attention Control | Physical Outcome | 3 months- Time 3 | 45.00 score on a scale | Standard Deviation 7.31 |
| Attention Control | Physical Outcome | 6 months- Time 4 | 45.10 score on a scale | Standard Deviation 8.07 |
| Resourcefulness Training Intervention© | Physical Outcome | 6 months- Time 4 | 46.40 score on a scale | Standard Deviation 8.53 |
| Resourcefulness Training Intervention© | Physical Outcome | 3 months- Time 3 | 46.10 score on a scale | Standard Deviation 8.01 |
| Resourcefulness Training Intervention© | Physical Outcome | Baseline- Time 1 | 44.00 score on a scale | Standard Deviation 7.28 |
| Resourcefulness Training Intervention© | Physical Outcome | 9 months- Time 5 | 48.20 score on a scale | Standard Deviation 8.19 |
| Resourcefulness Training Intervention© | Physical Outcome | 6 weeks- Time 2 | 45.00 score on a scale | Standard Deviation 8.07 |
p-value: <0.05Mixed Models Analysis
Primary
Positive Health Practices
Personal Lifestyle Questionnaire- Positive Health Practices Personal Lifestyle Questionnaire (PLQ). Measures the positive health practices of exercise, substance use, nutrition, relaxation, safety, and health promotion. Twenty-four (24) items 4-point summated rating scale with a range of possible scores from 24 to 96 Higher scores reflect the practice of more health behaviors. Total scores are reported.
Time frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Population: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Positive Health Practices | Female 3 months- Time 3 | 66.805 score on a scale | Standard Deviation 9.159 |
| Attention Control | Positive Health Practices | Male Baseline- Time 1 | 63.227 score on a scale | Standard Deviation 8.433 |
| Attention Control | Positive Health Practices | Female 6 weeks- Time 2 | 65.767 score on a scale | Standard Deviation 9.054 |
| Attention Control | Positive Health Practices | Male 6 weeks- Time 2 | 64.233 score on a scale | Standard Deviation 8.714 |
| Attention Control | Positive Health Practices | Female 6 months- Time 4 | 67.743 score on a scale | Standard Deviation 8.421 |
| Attention Control | Positive Health Practices | Male 3 months- Time 3 | 65.439 score on a scale | Standard Deviation 8.844 |
| Attention Control | Positive Health Practices | Female Baseline- Time 1 | 64.515 score on a scale | Standard Deviation 8.963 |
| Attention Control | Positive Health Practices | Male 6 months- Time 4 | 66.329 score on a scale | Standard Deviation 8.156 |
| Attention Control | Positive Health Practices | Male 9 months- Time 5 | 65.269 score on a scale | Standard Deviation 8.288 |
| Attention Control | Positive Health Practices | Female 9 months- Time 5 | 66.642 score on a scale | Standard Deviation 8.433 |
| Resourcefulness Training Intervention© | Positive Health Practices | Male 9 months- Time 5 | 67.597 score on a scale | Standard Deviation 9.565 |
| Resourcefulness Training Intervention© | Positive Health Practices | Female Baseline- Time 1 | 64.4 score on a scale | Standard Deviation 8.357 |
| Resourcefulness Training Intervention© | Positive Health Practices | Female 6 weeks- Time 2 | 65.811 score on a scale | Standard Deviation 9.727 |
| Resourcefulness Training Intervention© | Positive Health Practices | Female 3 months- Time 3 | 67.352 score on a scale | Standard Deviation 8.626 |
| Resourcefulness Training Intervention© | Positive Health Practices | Female 6 months- Time 4 | 68.277 score on a scale | Standard Deviation 8.592 |
| Resourcefulness Training Intervention© | Positive Health Practices | Female 9 months- Time 5 | 69.0 score on a scale | Standard Deviation 9.987 |
| Resourcefulness Training Intervention© | Positive Health Practices | Male Baseline- Time 1 | 63.35 score on a scale | Standard Deviation 8.158 |
| Resourcefulness Training Intervention© | Positive Health Practices | Male 6 weeks- Time 2 | 64.757 score on a scale | Standard Deviation 9.379 |
| Resourcefulness Training Intervention© | Positive Health Practices | Male 3 months- Time 3 | 66.254 score on a scale | Standard Deviation 8.397 |
| Resourcefulness Training Intervention© | Positive Health Practices | Male 6 months- Time 4 | 67.2 score on a scale | Standard Deviation 8.337 |
Primary
Psychological Outcome- Health Related Quality of Life
Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health.
Time frame: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Population: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Psychological Outcome- Health Related Quality of Life | Baseline- Time 1 | 40.5 score on a scale | Standard Deviation 9.21 |
| Attention Control | Psychological Outcome- Health Related Quality of Life | 6 months- Time 4 | 42.60 score on a scale | Standard Deviation 9.41 |
| Attention Control | Psychological Outcome- Health Related Quality of Life | 3 months- Time 3 | 41.7 score on a scale | Standard Deviation 8.23 |
| Attention Control | Psychological Outcome- Health Related Quality of Life | 9 months- Time 5 | 42.40 score on a scale | Standard Deviation 8.87 |
| Attention Control | Psychological Outcome- Health Related Quality of Life | 6 weeks- Time 2 | 41.9 score on a scale | Standard Deviation 8.95 |
| Resourcefulness Training Intervention© | Psychological Outcome- Health Related Quality of Life | 9 months- Time 5 | 42.50 score on a scale | Standard Deviation 8.61 |
| Resourcefulness Training Intervention© | Psychological Outcome- Health Related Quality of Life | Baseline- Time 1 | 37.0 score on a scale | Standard Deviation 8.85 |
| Resourcefulness Training Intervention© | Psychological Outcome- Health Related Quality of Life | 6 weeks- Time 2 | 39.70 score on a scale | Standard Deviation 9.31 |
| Resourcefulness Training Intervention© | Psychological Outcome- Health Related Quality of Life | 3 months- Time 3 | 40.70 score on a scale | Standard Deviation 9.04 |
| Resourcefulness Training Intervention© | Psychological Outcome- Health Related Quality of Life | 6 months- Time 4 | 41.00 score on a scale | Standard Deviation 10 |
p-value: <0.05Mixed Models Analysis
Primary
Self-Management- Sleep- Subjective
Appraised Sleep Quality (Pittsburgh Sleep Quality Index), Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI). Assesses sleep quality and disturbances over a l-month time interval. Nineteen (19) items are grouped into seven component scores, each weighted equally on a 0-3 scale. Score Range (Global PSQI Score) is 0-21. Higher scores indicate worse sleep quality. Sub Scales are summed
Time frame: Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baseline
Population: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attention Control | Self-Management- Sleep- Subjective | Baseline- Time 1 | 7.134 score on a scale | Standard Deviation 3.239 |
| Attention Control | Self-Management- Sleep- Subjective | 3 months- Time 3 | 6.278 score on a scale | Standard Deviation 3.4 |
| Attention Control | Self-Management- Sleep- Subjective | 6 months- Time 4 | 6.058 score on a scale | Standard Deviation 3.014 |
| Attention Control | Self-Management- Sleep- Subjective | 9 months- Time 5 | 6.254 score on a scale | Standard Deviation 2.93 |
| Resourcefulness Training Intervention© | Self-Management- Sleep- Subjective | 9 months- Time 5 | 6.161 score on a scale | Standard Deviation 2.729 |
| Resourcefulness Training Intervention© | Self-Management- Sleep- Subjective | Baseline- Time 1 | 7.59 score on a scale | Standard Deviation 2.903 |
| Resourcefulness Training Intervention© | Self-Management- Sleep- Subjective | 6 months- Time 4 | 6.406 score on a scale | Standard Deviation 2.866 |
| Resourcefulness Training Intervention© | Self-Management- Sleep- Subjective | 3 months- Time 3 | 6.768 score on a scale | Standard Deviation 2.68 |
Secondary
Number of Technology-Dependent Children With ER Visits
Number of Technology-Dependent Children with ER Visits over the time period the parent was enrolled and participating in the study from review of the children's charts.
Time frame: Up to 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Number of Technology-Dependent Children With ER Visits | 0.9592 Number of ER visits | Standard Deviation 1.566 |
| Resourcefulness Training Intervention© | Number of Technology-Dependent Children With ER Visits | 0.9108 Number of ER visits | Standard Deviation 1.569 |
p-value: <0.05t-test, 2 sided
Secondary
Number of Technology-Dependent Children With Rehospitalizations
Number of Technology-Dependent Children with Rehospitalizations over the time period the parent was enrolled and participating in the study from review of the children's charts.
Time frame: Up to 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Number of Technology-Dependent Children With Rehospitalizations | 0.7755 Number of rehospitalizations | Standard Deviation 1.343 |
| Resourcefulness Training Intervention© | Number of Technology-Dependent Children With Rehospitalizations | 0.8415 Number of rehospitalizations | Standard Deviation 1.384 |