Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

Not Applicable

Recruiting

• Conditions: Overweight and Obesity; Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea
• Interventions: Other: FOCuSEd Integrated Intervention; Other: Enhanced Usual Care

• Registration Number: NCT06390345
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Brief Summary

The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Status Verified: 2024-07
• Study Start: 2024-07-29
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2028-07-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
• ≥10 pack year history of tobacco use
• Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
• BMI ≥ 25 kg/m2
• Symptoms of dyspnea defined by MMRC score of ≥2

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Exclusion Criteria

• Self-report of weight change >15 lbs. during prior 3 months
• Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
• Severe illness from any cause
• Diagnosis of bulimia or history of purging behavior
• Active enrollment in pulmonary rehabilitation
• Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy < 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.
• Pregnant, lactating, or planning to become pregnant during the study period
• Participation in other intervention studies.
• Prisoner
• Unable to complete surveys in English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOCuSEd Intervention	FOCuSEd Integrated Intervention	Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.
Usual Care- Enhanced	Enhanced Usual Care	For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs.

Primary Outcome Measures

Name	Time	Method
The SF-12 PCS	1 year	The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.

Secondary Outcome Measures

Name	Time	Method
PROMIS Sleep-related impairment	3 months	The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
SF-12 PCS	3 months	The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.
Weight Loss	1 year	Total (kg)
Cardiovascular risk score	1 year	Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Strength and endurance	1 year	30 second chair stand
SF-12 MCS	1 year	The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Social Support	1 year	Social Support for diet and exercise scales
Depression	1 year	PHQ-8 Depression scale
PROMIS Sleep Disturbance	1 year	The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
COPD exacerbation or death	1 year	Proportion of patients with COPD exacerbation or Death (composite outcome) \[ Time Frame: 12 months after randomization \]
COPD Assessment Test (CAT)	1 year	The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
OSA Severity	1 Year	Home-Sleep Apnea Testing: Respiratory Event Index
Clinically Significant Weight Loss	1 year	5% weight loss met

Trial Locations

Locations (5)

Jesse Brown VA Medical Center; 🇺🇸 Chicago, Illinois, United States

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States

Minneapolis VA Health Care System; 🇺🇸 Minneapolis, Minnesota, United States

Boise VA Medical Center; 🇺🇸 Boise, Idaho, United States

Mann-Grandstaff VA Medical Center; 🇺🇸 Spokane, Washington, United States