Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

NCT04506112 | Withdrawn

• 2 other identifiers: E3393-WRX003393
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Wake Disorders; Sleep Disturbance; Sleep-Related Impairment

Keywords

Veterans; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Short Physical Performance Battery (SPPB) 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

• Life Space Assessment 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

Other Outcomes (2)

• Pittsburgh Sleep Quality Index from Baseline to 3 and 6 months

  Baseline to 3 and 6 months

• Insomnia Severity Index from Baseline to 3 and 6 months

  Baseline to 3 and 6 months

Study Arms (2)

TranS-C + Usual Care

EXPERIMENTAL

Participants in this group will receive TranS-C and will continue with care in cardiac rehabilitation as usual.

Behavioral: Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation

Usual Care

NO INTERVENTION

Participants in this group will receive only usual care and thus will continue with care in cardiac rehabilitation as usual.

Interventions

Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation BEHAVIORAL

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.

Also known as: TranS-C

TranS-C + Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Parasomnias

Interventions

Acclimatization; Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Caitlan A. Tighe, PhD MA

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Pilot randomized trial with participants assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: January 27, 2022
• Primary Completion: April 16, 2023
• Study Completion: April 16, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Prior to the end of the study.
• Access Criteria: A Limited Dataset (LDS) may be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Locations

US (1)