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

Chronic Obstructive Pulmonary Disease Clinical Trial

— FOCuSEd  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Obstructive Sleep Apnea
• Overweight
• Overweight and Obesity
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea, Obstructive

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