Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

Sleep Disturbance Clinical Trial

Official title:

Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04506112
• Other study ID #: E3393-W
• Secondary ID: RX003393
• Status: Withdrawn
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: April 16, 2023

Study information

• Verified date: May 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 16, 2023
• Est. primary completion date: April 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran

• 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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders
• Sleep-Related Impairment

Intervention

Behavioral:
• Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation
Participants will complete the TranS-C intervention as adapted for cardiac rehabilitation. TranS-C is a behavioral intervention that is rooted in basic sleep and circadian science and draws from empirically-supported treatments including Cognitive Behavioral Therapy for Insomnia (CBT-I), Interpersonal and Social Rhythm Therapy (IPSRT), chronotherapy, and light therapy. It was designed to promote sleep health across a range of sleep problems. Participants in this group will also continue to receive care as usual, cardiac/sleep-related or otherwise.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh Sleep Quality Index from Baseline to 3 and 6 months	Validated self-report measure of global sleep quality. Items assess past-month subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Global sleep quality scores range from 0 to 21. Higher scores are indicative of worse sleep quality.	Baseline to 3 and 6 months
Other	Insomnia Severity Index from Baseline to 3 and 6 months	Validated self-report measure of insomnia symptoms over the past 2 weeks. Contains 7 items assessing severity of insomnia symptoms. Scores range from 0 to 28. Higher scores are indicative of greater insomnia severity.	Baseline to 3 and 6 months
Primary	Multidimensional Treatment Satisfaction Measure	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.	3 months
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Disturbance 8a from 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.	Baseline to 3 and 6 months
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Related Impairment 8a from 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.	Baseline to 3 and 6 months
Primary	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) from 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.	Baseline to 3 and 6 months
Primary	MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew) from Baseline to 3 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.	Baseline to 3 months and 6 months
Secondary	Short Physical Performance Battery (SPPB) from Baseline to 3 and 6 months	Validated performance-based measure of physical function. Includes assessments of gait speed, functional strength, and standing balance. Total scores range from 0 to 12. Higher scores are indicative of better performance.	Baseline to 3 and 6 months
Secondary	Physical Performance Test (PPT)from Baseline to 3 and 6 months	Validated performance-based measure of physical functioning. Requires participants to perform 7 activities that simulate activities of daily living (e.g., writing a sentence, putting on a jacket). Scores range from 0 to 28. Higher scores are indicative of better performance.	Baseline to 3 and 6 months
Secondary	Life Space Assessment from Baseline to 3 and 6 months	Validated self-report measure of life space mobility (i.e., the spatial area in which a person navigates). Respondents indicate how far and how often they have traveled to various places (e.g., in immediate neighborhood, outside immediate town or community) in the past 4 weeks. Composite scores range from 0 to 120. Higher scores are suggestive of greater life space mobility.	Baseline to 3 and 6 months
Secondary	World Health Organization Quality of Life-BREF (WHOQOL-BREF) from Baseline to 3 and 6 months	Validated self-report measure of quality of life. Contains 26 items that assess and yield scores representative of quality of life in the domains of physical health, psychological health, social relationships, and environment. Domain scores range from 0 to 100. Higher scores are indicative of higher quality of life.	Baseline to 3 and 6 months