Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
NCT ID: NCT05119556
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
768 participants
INTERVENTIONAL
2022-06-28
2028-07-31
Brief Summary
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Detailed Description
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All patients with a clinical diagnosis of COPD who are hospitalized for an acute exacerbation of COPD at each clinical site will be considered for inclusion. Interested participants will be seen at 8 (-3 to +4) days after discharge from the hospital. At this visit, participants will be randomized 1:1, in varying blocks, stratified by site, to video telehealth PR plus standard of care versus standard of care alone. The telehealth intervention will involve 3 exercise sessions a week for 12 weeks. Exercise sessions will be provided in real-time via live two-way videoconferencing using a HIPAA-compliant app on an encrypted smart phone or similar device. Each session will be standardized to include cardiovascular (aerobic) training, strength (resistance) training, breathing exercises, and education that includes smoking cessation counselling where applicable, inhaler use techniques, diet, and nutrition. Participants in both the intervention and control arms will receive standard of care per local guidance. During the period of active intervention, participants in both arms will be contacted monthly to ascertain any exacerbations. Questionnaires and assessments of function will be administered at the baseline 8 day visit and at completion of the intervention at 13 weeks. Subsequently, participants in both arms will be called 3-monthly to ascertain healthcare utilization, and questionnaires and assessments of function will be repeated at the end of the follow-up period at 52 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of Care
Participants will receive standard of care for COPD management per local guidance. In addition, they will receive 4-weekly phone calls for 13 weeks post discharge to inquire about health status and exacerbations.
No interventions assigned to this group
Video Telehealth Pulmonary Rehabilitation
In addition to standard of care, participants will be asked to participate in rehabilitation sessions administered at home via live videoconferencing for approximately 60 minutes a session, three times a week. A total of 36 sessions will be planned to be completed by week 13 post-discharge. Exacerbations and health status will be ascertained every 4-weeks for 13 weeks.
Video Telehealth Pulmonary Rehabilitation
Participant will be asked to exercise 3 times a week at their home for 60 minutes each session, via live two-way videoconferencing using a data-enabled smart phone or similar device. A total of 36 sessions will be administered over 13 weeks post-discharge. Sessions will be administered by exercise physiologists located at the University of Alabama at Birmingham. Each session will be scheduled with up to three other participants at a time to mimic group sessions as delivered at center-based pulmonary rehabilitation programs. Exercise sessions will include aerobics, strength or resistance training, breathing exercises, and education sessions. The exercise plans will be tailored according to the participants' baseline exercise tolerance as determined by an initial six minute walk test and their answers to the questionnaires at the baseline visit.
Interventions
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Video Telehealth Pulmonary Rehabilitation
Participant will be asked to exercise 3 times a week at their home for 60 minutes each session, via live two-way videoconferencing using a data-enabled smart phone or similar device. A total of 36 sessions will be administered over 13 weeks post-discharge. Sessions will be administered by exercise physiologists located at the University of Alabama at Birmingham. Each session will be scheduled with up to three other participants at a time to mimic group sessions as delivered at center-based pulmonary rehabilitation programs. Exercise sessions will include aerobics, strength or resistance training, breathing exercises, and education sessions. The exercise plans will be tailored according to the participants' baseline exercise tolerance as determined by an initial six minute walk test and their answers to the questionnaires at the baseline visit.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of COPD
3. Hospitalized for acute exacerbation of COPD.
4. Be willing to adhere to trial and follow-up procedures and give informed consent
Exclusion Criteria
2. Other respiratory conditions that could confound the diagnosis such as asthma, pulmonary fibrosis, bronchiectasis, and lung cancer. Participants with pneumonic exacerbations of COPD will be included.
3. Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded.
4. Active cancers on chemotherapy or radiation therapy
5. Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS
6. Active or recent (within 1 month) myocardial infarction
7. Angina not well-controlled by medication
8. Unstable cardiac arrhythmias, atrial or ventricular
9. Supplemental oxygen requirement greater than 5 liters per minute at either rest or with exertion
10. Significant cognitive dysfunction, including dementia, that in opinion of investigator would impair ability to safely or effectively engage in study protocol
11. Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice
12. Currently enrolled in and participating in pulmonary rehabilitation
13. Treatment with chronic or newly initiated home ventilatory support. Those on in-patient short-term non-invasive ventilation will not be excluded.
14. Special patient groups such as prisoners and institutionalized patients
15. Participants with musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program
16. Current participation in any other interventional clinical trial
17. Inability to understand and speak English during exercise sessions
18. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
40 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Surya P Bhatt
Professor of Medicine
Principal Investigators
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Surya P Bhatt, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland
College Park, Maryland, United States
Boston VA Hospital
Boston, Massachusetts, United States
HealthPartners Institute
Bloomington, Minnesota, United States
Minnesota VA HealthCare System
Minneapolis, Minnesota, United States
Northern Westchester Hospital/Northwell Health
Chappaqua, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Cincinnati VA Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300008210
Identifier Type: -
Identifier Source: org_study_id
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