Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Wake Disorders
- Sponsor
- VA Office of Research and Development
- Locations
- 1
- Primary Endpoint
- Multidimensional Treatment Satisfaction Measure
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.
Detailed Description
Aim 1 will involve formative work to optimize the TranS-C manual and protocol for delivery in Cardiac Rehabilitation, with input from Veterans and provider stakeholders. Aim 2 will involve a preliminary test and refinement of the adapted TranS-C manual and protocol with a small sample of Veterans who are participating in cardiac rehabilitation and report sleep disturbance and/or sleep-related impairment. Aim 3 will involve a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures. Veterans in cardiac rehabilitation with sleep disturbance and/or sleep-related impairment will be randomized to TranS-C + Usual Care or Usual Care. Treatment satisfaction will be assessed at 3-months; sleep disturbance and sleep-related impairment, disability and functioning, and health-related quality of life will be assessed at baseline, 3-months, and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects. Of note, information provided in this entry (e.g., design, eligibility criteria, outcomes, etc.) pertains only to Aim 3 which includes the pilot randomized trial. Consistent with Stage I of the NIH stage model of behavioral intervention development research, results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Referred for VAPHS cardiac rehabilitation
- •Self-reported sleep disturbance or sleep-related impairment, determined by PROMIS Sleep Disturbance T-score at least 55 (raw score at least 25) or PROMIS Sleep-Related Impairment T-score at least 55 (raw score at least 20)
- •English language fluency
- •Willing and able to voluntarily participate in a behavioral sleep intervention clinical research study
- •Willing to permit study personnel access to VA EHR
- •Willing to permit study personnel to communicate with routine VA healthcare providers
- •Willing and able to participate in outpatient cardiac rehabilitation at VAPHS
Exclusion Criteria
- •Moderate to severe cognitive impairment
- •Active suicidal ideation, plan, or intent
- •Current moderate to severe alcohol or substance use disorder
- •Current severe symptoms of depression, anxiety, mania/hypomania, psychosis, or PTSD
- •Currently engaged in a non-pharmacological intervention for sleep
- •Currently working night shifts
- •Currently pregnant and/or breast-feeding
Outcomes
Primary Outcomes
Multidimensional Treatment Satisfaction Measure
Time Frame: 3 months
Self-report measure of patient satisfaction with behavioral intervention process and outcomes. Subscale scores range from 0-4. Higher scores are suggestive of greater satisfaction with treatment.
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Disturbance 8a from Baseline to 3 and 6 months
Time Frame: Baseline to 3 and 6 months
Validated self-report measure of global sleep disturbance over the preceding 7 days. Produces raw score and T-score values, where 50 is the mean of the reference population and 10 is the standard deviation. Higher scores are indicative of greater sleep disturbance.
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Related Impairment 8a from Baseline to 3 and 6 months
Time Frame: Baseline to 3 and 6 months
Validated self-report measure of sleep-related impairment over the preceding 7 days. Produces raw score and T-score values, where 50 is the mean of the reference population and 10 is the standard deviation. Higher scores are indicative of greater sleep-related impairment.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) from Baseline to 3 and 6 months
Time Frame: Baseline to 3 and 6 months
Validated self-report measure of disability and functioning associated with physical and mental disorders. The WHODAS 2.0 contains 36-items that assess functioning in the domains of cognition, mobility, self-care, getting along, life activities, and participation over the preceding 30 days. The outcome of interest is the WHODAS 2.0 summary score. Using the complex scoring method, scores range from 0 to 100. Higher scores are indicative of greater disability.
MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew) from Baseline to 3 and 6 months
Time Frame: Baseline to 3 months and 6 months
Validated self-report measure of health-related quality of life in patients with heart disease. Contains 27 items that assess physical limitations, emotional function, social function, and symptoms common in heart disease (e.g., angina/chest pain, shortness of breath, fatigue, aching legs). The outcome of interest is the total health-related quality of life score. Scores range from 1 to 7. Higher scores are indicative of higher levels of health-related quality of life.
Secondary Outcomes
- Short Physical Performance Battery (SPPB) from Baseline to 3 and 6 months(Baseline to 3 and 6 months)
- Life Space Assessment from Baseline to 3 and 6 months(Baseline to 3 and 6 months)
- Physical Performance Test (PPT)from Baseline to 3 and 6 months(Baseline to 3 and 6 months)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) from Baseline to 3 and 6 months(Baseline to 3 and 6 months)