Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease

Last updated: April 2, 2026
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Video Telehealth Pulmonary Rehabilitation

Clinical Study ID

NCT05119556
IRB-300008210
1UG3HL155806-01A1
  • Ages > 40
  • All Genders

Study Summary

The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 40 or greater

  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

Exclusion Criteria:

  1. Secondary diagnosis of congestive heart failure that is severe as documented byactive symptoms, New York Heart Association (NYHA) functional classification IV orleft ventricular ejection fraction <25% on echocardiography

  2. Other respiratory conditions that could confound the diagnosis such as asthma,pulmonary fibrosis, bronchiectasis, and lung cancer. Participants with pneumonicexacerbations of COPD will be included.

  3. Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVIDor persistently positive for COVID but deemed to be convalescent will not beexcluded.

  4. Active cancers on chemotherapy or radiation therapy

  5. Immunosuppressed states predisposing to frequent hospitalizations includinguncontrolled 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 orwith exertion

  10. Significant cognitive dysfunction, including dementia, that in opinion ofinvestigator would impair ability to safely or effectively engage in study protocol

  11. Participants with any terminal medical illnesses as diagnosed by a physician, and/oron hospice

  12. Currently enrolled in and participating in pulmonary rehabilitation

  13. Treatment with chronic or newly initiated home ventilatory support. Those onin-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 thatpreclude 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 outlinedin the protocol

Study Design

Total Participants: 768
Treatment Group(s): 1
Primary Treatment: Video Telehealth Pulmonary Rehabilitation
Phase:
Study Start date:
June 28, 2022
Estimated Completion Date:
July 31, 2027

Study Description

This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial (n=768 at 14 clinical sites) comparing the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for COPD exacerbation to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.

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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland

    College Park, Maryland 20742
    United States

    Site Not Available

  • Boston VA Hospital

    Boston, Massachusetts 02130
    United States

    Site Not Available

  • HealthPartners Institute

    Bloomington, Minnesota 55440
    United States

    Site Not Available

  • Minnesota VA HealthCare System

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Northern Westchester Hospital/Northwell Health

    Chappaqua, New York 10514
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem, North Carolina 27109
    United States

    Site Not Available

  • Cincinnati VA Hospital

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19122
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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