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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06390345
Other study ID # 1766415
Secondary ID TE-2022C3-30598
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date October 1, 2028

Study information

Verified date April 2024
Source Seattle Institute for Biomedical and Clinical Research
Contact Brianna Moss
Phone 206.277.4166
Email brianna.moss@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with COPD and OSA. We will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. We 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, we 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. Our 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, we will also conduct a concurrent implementation process evaluation using the RE-AIM framework.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date October 1, 2028
Est. primary completion date July 1, 2028
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 - = 40 years old 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

Study Design


Intervention

Other:
FOCuSEd Integrated Intervention
Participants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of = 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.
Enhanced Usual Care
Participants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider.

Locations

Country Name City State
United States Boise VA Medical Center Boise Idaho
United States Jesse Brown VA Medical Center Chicago Illinois
United States Minneapolis VA Health Care System Minneapolis Minnesota
United States VA Puget Sound Health Care System Seattle Washington
United States Mann-Grandstaff VA Medical Center Spokane Washington

Sponsors (2)

Lead Sponsor Collaborator
Seattle Institute for Biomedical and Clinical Research Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health-Related Quality of life Physical Component Score (PCS) of Short Form (SF) - 12 1 year
Secondary Sleep-related impairment Patient-Reported Outcomes Information System (PROMIS) Sleep-Related Impairment (SRI) 1 year
Secondary Sleep-related impairment Patient-Reported Outcomes Information System (PROMIS) Sleep-Related Impairment (SRI) 3 months
Secondary Health-related Quality of Life Physical Component Score (PCS) of Short Form (SF) - 12 3 months
Secondary Health-Related Impairment Mental Component Score (MCS) of SF-12 3 months
Secondary Health-Related Impairment Mental Component Score (MCS) of SF-12 1 year
Secondary Sleep Disturbance PROMIS Sleep Disturbance (SDA) 3 months
Secondary Sleep Disturbance PROMIS Sleep Disturbance (SDA) 1 year
Secondary Clinical Outcomes Death or Exacerbations 3 months
Secondary Clinical Outcomes Death or Exacerbations 1 year
Secondary Disease-specific quality of life COPD Assessment Test (CAT) 3 months
Secondary Disease-specific quality of life COPD Assessment Test (CAT) 1 year
Secondary Weight Loss Total (kg) 3 months
Secondary Weight Loss Total (kg) 1 year
Secondary Clinically Significant Weight Loss 5% weight loss met 3 months
Secondary Clinically Significant Weight Loss 5% weight loss met 1 year
Secondary Cardiovascular risk Framingham risk score 3 months
Secondary Cardiovascular risk Framingham risk score 1 year
Secondary Social Support Social Support for diet and exercise scales 3 months
Secondary Social Support Social Support for diet and exercise scales 1 year
Secondary Depression PHQ-8 Depression scale 3 months
Secondary Depression PHQ-8 Depression scale 1 year
Secondary Strength and endurance 30 second chair stand 3 months
Secondary Strength and endurance 30 second chair stand 1 year
Secondary OSA Severity Home-Sleep Apnea Testing: Respiratory Event Index 1 Year
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