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

Обзор

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.

Вмешательства

• Другое 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 add
• Другое 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.

Первичные конечные точки

• The SF-12 PCS [Срок оценки: 1 year]

Вторичные конечные точки (12)

• PROMIS Sleep-related impairment [Срок оценки: 1 year]
• PROMIS Sleep-related impairment [Срок оценки: 3 months]
• SF-12 PCS [Срок оценки: 3 months]
• SF-12 MCS [Срок оценки: 3 months]
• SF-12 MCS [Срок оценки: 1 year]
• PROMIS Sleep Disturbance [Срок оценки: 3 months]
• PROMIS Sleep Disturbance [Срок оценки: 1 year]
• COPD exacerbation or death [Срок оценки: 3 months]
• COPD exacerbation or death [Срок оценки: 1 year]
• COPD Assessment Test (CAT) [Срок оценки: 3 months]
• COPD Assessment Test (CAT) [Срок оценки: 1 year]
• Weight Loss [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Boise VA Medical Center — Boise
• Jesse Brown VA Medical Center — Chicago
• Minneapolis VA Health Care System — Minneapolis
• VA Puget Sound Health Care System — Seattle
• Mann-Grandstaff VA Medical Center — Spokane

Идентификаторы

NCT: NCT06390345 · 1766415 · TE-2022C3-30598

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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