[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06390345":3,"trial-entities:NCT06390345":203,"trial-summary:NCT06390345":207},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":98,"minimum_age":99,"maximum_age":16,"healthy_volunteers":100,"eligibility_criteria":101,"std_ages":120,"locations":123,"central_contacts":198,"overall_officials":200,"references":201,"see_also_links":202},"NCT06390345","1766415","Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention","RECRUITING","2028-10-01","2026-07","2026-07-22","2024-07-29","Seattle Institute for Biomedical and Clinical Research","OTHER",true,"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. \\\u003C 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.",null,[18,19,20],"Chronic Obstructive Pulmonary Disease","Obstructive Sleep Apnea","Overweight and Obesity",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},400,"ESTIMATED",[30,35],{"type":13,"name":31,"description":32,"armGroupLabels":33},"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\u002Fm2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.",[34],"FOCuSEd Intervention",{"type":13,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Usual Care- Enhanced",[41],{"measure":42,"description":43,"timeFrame":44},"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",[46,49,51,53,56,57,60,61,64,66,69,70,73,74,77,78,81,82,85,86,89,90,93,94],{"measure":47,"description":48,"timeFrame":44},"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.",{"measure":47,"description":48,"timeFrame":50},"3 months",{"measure":52,"description":43,"timeFrame":50},"SF-12 PCS",{"measure":54,"description":55,"timeFrame":50},"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.",{"measure":54,"description":55,"timeFrame":44},{"measure":58,"description":59,"timeFrame":50},"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.",{"measure":58,"description":59,"timeFrame":44},{"measure":62,"description":63,"timeFrame":50},"COPD exacerbation or death","Proportion of patients with COPD exacerbation or Death (composite outcome) \\[ Time Frame: 3 months after randomization \\]",{"measure":62,"description":65,"timeFrame":44},"Proportion of patients with COPD exacerbation or Death (composite outcome) \\[ Time Frame: 12 months after randomization \\]",{"measure":67,"description":68,"timeFrame":50},"COPD Assessment Test (CAT)","The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.",{"measure":67,"description":68,"timeFrame":44},{"measure":71,"description":72,"timeFrame":50},"Weight Loss","Total (kg)",{"measure":71,"description":72,"timeFrame":44},{"measure":75,"description":76,"timeFrame":50},"Clinically Significant Weight Loss","5% weight loss met",{"measure":75,"description":76,"timeFrame":44},{"measure":79,"description":80,"timeFrame":50},"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.",{"measure":79,"description":80,"timeFrame":44},{"measure":83,"description":84,"timeFrame":50},"Social Support","Social Support for diet and exercise scales",{"measure":83,"description":84,"timeFrame":44},{"measure":87,"description":88,"timeFrame":50},"Depression","PHQ-8 Depression scale",{"measure":87,"description":88,"timeFrame":44},{"measure":91,"description":92,"timeFrame":50},"Strength and endurance","30 second chair stand",{"measure":91,"description":92,"timeFrame":44},{"measure":95,"description":96,"timeFrame":97},"OSA Severity","Home-Sleep Apnea Testing: Respiratory Event Index","1 Year","ALL","18 Years",false,{"inclusion":102,"exclusion":108,"raw_text":119},[103,104,105,106,107],"COPD: Defined by presence of airflow obstruction (FEV1\u002FFVC \\\u003C 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\u002Fm2","Symptoms of dyspnea defined by MMRC score of ≥1",[109,110,111,112,113,114,115,116,117,118],"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\u002For adherence concerns due to severe physical or mental health issues or life expectancy \\\u003C 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","Inclusion Criteria:\n\n* COPD: Defined by presence of airflow obstruction (FEV1\u002FFVC \\\u003C 0.70) on post-bronchodilator spirometry\n* ≥10 pack year history of tobacco use\n* Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)\n* BMI ≥ 25 kg\u002Fm2\n* Symptoms of dyspnea defined by MMRC score of ≥1\n\nExclusion Criteria:\n\n* Self-report of weight change \\>15 lbs. during prior 3 months\n* 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.\n* Severe illness from any cause\n* Diagnosis of bulimia or history of purging behavior\n* Active enrollment in pulmonary rehabilitation\n* Safety and\u002For adherence concerns due to severe physical or mental health issues or life expectancy \\\u003C 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.\n* Pregnant, lactating, or planning to become pregnant during the study period\n* Participation in other intervention studies.\n* Prisoner\n* Unable to complete surveys in English",[121,122],"ADULT","OLDER_ADULT",[124,143,157,171,186],{"facility":125,"status":7,"city":126,"state":127,"zip":128,"country":129,"contacts":130,"geoPoint":140},"Boise VA Medical Center","Boise","Idaho","83702","United States",[131,135,138],{"name":132,"role":133,"email":134},"Brianna Moss","CONTACT","brianna.moss@va.gov",{"name":136,"role":137},"Paula Carvalho, MD","PRINCIPAL_INVESTIGATOR",{"name":139,"role":137},"William Weppner, MD",{"lat":141,"lon":142},43.6135,-116.20345,{"facility":144,"status":7,"city":145,"state":146,"zip":147,"country":129,"contacts":148,"geoPoint":154},"Jesse Brown VA Medical Center","Chicago","Illinois","60612",[149,150,152],{"name":132,"role":133,"email":134},{"name":151,"role":137},"Min Joo, MD",{"name":153,"role":137},"Stephanie LaBedz, MD",{"lat":155,"lon":156},41.85003,-87.65005,{"facility":158,"status":7,"city":159,"state":160,"zip":161,"country":129,"contacts":162,"geoPoint":168},"Minneapolis VA Health Care System","Minneapolis","Minnesota","55417",[163,164,166],{"name":132,"role":133,"email":134},{"name":165,"role":137},"Charles Billington, MD",{"name":167,"role":137},"Benjamin Henkle, MD",{"lat":169,"lon":170},44.97997,-93.26384,{"facility":172,"status":7,"city":173,"state":174,"zip":175,"country":129,"contacts":176,"geoPoint":183},"VA Puget Sound Health Care System","Seattle","Washington","98108",[177,179,181],{"name":132,"role":133,"phone":178,"email":134},"206.277.4166",{"name":180,"role":137},"Laura C Feemster, MD MS",{"name":182,"role":137},"Lucas M Donovan, MD MS",{"lat":184,"lon":185},47.60621,-122.33207,{"facility":187,"status":7,"city":188,"state":174,"zip":189,"country":129,"contacts":190,"geoPoint":195},"Mann-Grandstaff VA Medical Center","Spokane","99205",[191,193],{"name":132,"role":133,"phone":192,"email":134},"206-277-4166",{"name":194,"role":137},"Allison A Lambert, MD",{"lat":196,"lon":197},47.65966,-117.42908,[199],{"name":132,"role":133,"phone":178,"email":134},[],[],[],{"nct_id":4,"conditions":204,"biomarkers":206},[18,19,205],"Overweight",[],{"nct_id":4,"found":14,"summary":208,"prompt_version":216},{"design":209,"status":210,"heading":6,"summary":211,"follow_up":209,"word_count":212,"commitments":213,"compensation":214,"drugs_mentioned":215},"Not specified.","completed","{\n   \"Telehealth Lifestyle and Exercise for COPD and OSA\",\n   \"This study is testing a telehealth (remote healthcare) program called FOCuSEd Integrated Intervention for people with Chronic Obstructive Pulmonary Disease (COPD), Obstructive Sleep Apnea (OSA), and who are overweight or obese. The program focuses on healthy eating and 150 minutes of moderate exercise each week. It's being compared to \\\"Enhanced Usual Care,\\\" which includes referrals to the VA's MOVE! weight loss program and pulmonary rehabilitation. The study aims to see if the FOCuSEd Integrated Intervention improves your physical health, measured by a health survey after one year. You might be able to join if you have COPD, a history of smoking, diagnosed OSA, a BMI of 25 or higher, and experience shortness of breath. The study plans to enroll 400 participants.\",\n  \"design\": \"This study will include 400 participants who will be randomly assigned to either the FOCuSEd Integrated Intervention or Enhanced Usual Care. This is an interventional study, meaning participants will receive specific treatments.\",\n  \"commitments\": \"Participants in the intervention group will receive a telehealth-delivered lifestyle program and supervised pulmonary rehabilitation. Participants in the usual care group will be referred to MOVE! and pulmonary rehabilitation. The primary outcome will be measured at 1 year.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Your physical health will be assessed at 1 year after starting the intervention.\",\n}",224,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]