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NCT Number: NCT06390345

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Apnea Body Weight Chronic Disease Disease Attributes Dyssomnias Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstructive Sleep Apnea Overnutrition Overweight Overweight and Obesity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boise VA Medical Center, Boise, Idaho, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOCuSEd Integrated Intervention

Other

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

Other

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.

Primary outcomes

  1. The SF-12 PCS

    Time frame: 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 outcomes

  1. PROMIS Sleep-related impairment

    Time frame: 1 year

    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.

  2. PROMIS Sleep-related impairment

    Time frame: 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.

  3. SF-12 PCS

    Time frame: 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.

  4. SF-12 MCS

    Time frame: 3 months

    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.

  5. SF-12 MCS

    Time frame: 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.

  6. PROMIS Sleep Disturbance

    Time frame: 3 months

    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.

  7. PROMIS Sleep Disturbance

    Time frame: 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.

  8. COPD exacerbation or death

    Time frame: 3 months

    Proportion of patients with COPD exacerbation or Death (composite outcome) [ Time Frame: 3 months after randomization ]

  9. COPD exacerbation or death

    Time frame: 1 year

    Proportion of patients with COPD exacerbation or Death (composite outcome) [ Time Frame: 12 months after randomization ]

  10. COPD Assessment Test (CAT)

    Time frame: 3 months

    The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.

  11. COPD Assessment Test (CAT)

    Time frame: 1 year

    The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.

  12. Weight Loss

    Time frame: 3 months

    Total (kg)

  13. Weight Loss

    Time frame: 1 year

    Total (kg)

  14. Clinically Significant Weight Loss

    Time frame: 3 months

    5% weight loss met

  15. Clinically Significant Weight Loss

    Time frame: 1 year

    5% weight loss met

  16. Cardiovascular risk score

    Time frame: 3 months

    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.

  17. Cardiovascular risk score

    Time frame: 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.

  18. Social Support

    Time frame: 3 months

    Social Support for diet and exercise scales

  19. Social Support

    Time frame: 1 year

    Social Support for diet and exercise scales

  20. Depression

    Time frame: 3 months

    PHQ-8 Depression scale

  21. Depression

    Time frame: 1 year

    PHQ-8 Depression scale

  22. Strength and endurance

    Time frame: 3 months

    30 second chair stand

  23. Strength and endurance

    Time frame: 1 year

    30 second chair stand

  24. OSA Severity

    Time frame: 1 Year

    Home-Sleep Apnea Testing: Respiratory Event Index

Study contacts

Contact information is provided by the study sponsor or research team.

Brianna Moss

CONTACT

[email protected]

206.277.4166

Sponsors and collaborators

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: FOCuSEd

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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