Clinical trial NCT04506112: Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
Official title: Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Wake Disorders
Sleep Disturbance
Sleep-Related Impairment
Keywords: Veterans
Cardiac Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized trial with participants assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional Treatment Satisfaction Measure
timeFrame: 3 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Disturbance 8a from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v 1.0-Sleep Related Impairment 8a from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew) from Baseline to 3 and 6 months
timeFrame: Baseline to 3 months and 6 months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB) from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: Physical Performance Test (PPT)from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: Life Space Assessment from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF) from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
Other outcomes:
measure: Pittsburgh Sleep Quality Index from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
measure: Insomnia Severity Index from Baseline to 3 and 6 months
timeFrame: Baseline to 3 and 6 months
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Caitlan A. Tighe, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: