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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brianna Moss; Phone Number: 206.277.4166; Email: brianna.moss@va.gov

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83702
      • Recruiting
      • Boise VA Medical Center
      • Contact: Brianna Moss; Email: brianna.moss@va.gov
      • Principal Investigator: Paula Carvalho, MD
      • Principal Investigator: William Weppner, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Jesse Brown VA Medical Center
      • Contact: Brianna Moss; Email: brianna.moss@va.gov
      • Principal Investigator: Min Joo, MD
      • Principal Investigator: Stephanie LaBedz, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Minneapolis VA Health Care System
      • Contact: Brianna Moss; Email: brianna.moss@va.gov
      • Principal Investigator: Charles Billington, MD
      • Principal Investigator: Benjamin Henkle, MD
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • VA Puget Sound Health Care System
      • Contact: Brianna Moss; Phone Number: 206.277.4166; Email: brianna.moss@va.gov
      • Principal Investigator: Laura C Feemster, MD MS
      • Principal Investigator: Lucas M Donovan, MD MS
    • Spokane, Washington, United States, 99205
      • Recruiting
      • Mann-Grandstaff VA Medical Center
      • Principal Investigator: Allison A Lambert, MD
      • Contact: Brianna Moss; Phone Number: 206-277-4166; Email: Brianna.Moss@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ≥1

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FOCuSEd Intervention; Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.	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.
Active Comparator: Usual Care- Enhanced; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The SF-12 PCS	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	Total (kg)	3 months
Weight Loss	Total (kg)	1 year
Clinically Significant Weight Loss	5% weight loss met	3 months
Clinically Significant Weight Loss	5% weight loss met	1 year
Social Support	Social Support for diet and exercise scales	3 months
Social Support	Social Support for diet and exercise scales	1 year
Depression	PHQ-8 Depression scale	3 months
Depression	PHQ-8 Depression scale	1 year
Strength and endurance	30 second chair stand	3 months
Strength and endurance	30 second chair stand	1 year
OSA Severity	Home-Sleep Apnea Testing: Respiratory Event Index	1 Year
PROMIS Sleep-related impairment	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.	1 year
PROMIS Sleep-related impairment	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.	3 months
SF-12 PCS	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.	3 months
SF-12 MCS	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.	3 months
SF-12 MCS	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.	1 year
PROMIS Sleep Disturbance	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.	3 months
PROMIS Sleep Disturbance	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.	1 year
COPD exacerbation or death	Proportion of patients with COPD exacerbation or Death (composite outcome) [ Time Frame: 3 months after randomization ]	3 months
COPD exacerbation or death	Proportion of patients with COPD exacerbation or Death (composite outcome) [ Time Frame: 12 months after randomization ]	1 year
COPD Assessment Test (CAT)	The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.	3 months
COPD Assessment Test (CAT)	The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.	1 year
Cardiovascular risk score	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.	3 months
Cardiovascular risk score	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.	1 year

Collaborators and Investigators

• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Nutrition Disorders; Chronic Disease; Disease Attributes; Overnutrition; Body Weight; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive
• Other Study ID Numbers: 1766415; TE-2022C3-30598 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share a de-identified data set with the Patient-Centered Outcomes Research Institute-designated repository
• IPD Sharing Time Frame: data will be available after 2029 for at least 6 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No