Video telehealth program for COPD rehabilitation

Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)

This study tests if a video telehealth program for COPD rehabilitation can help people recover better and avoid going back to the hospital compared to regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 768 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 15 sites (Birmingham, Alabama and 14 other locations)
• Trial ID: NCT05119556 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effectiveness of a real-time video telehealth pulmonary rehabilitation program against standard care for patients hospitalized due to chronic obstructive pulmonary disease (COPD) exacerbations. Over 52 weeks, 768 participants will be randomized to receive either the telehealth intervention, which includes exercise sessions and education, or standard care alone. The study aims to assess the impact on hospital readmissions, respiratory health, and the cost-effectiveness of the telehealth approach.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 or older with a clinical diagnosis of COPD who have been hospitalized for an acute exacerbation.

Not a fit: Patients with severe congestive heart failure or other significant respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce hospital readmissions and improve the quality of life for patients with COPD.

How similar studies have performed: Other studies have shown promising results with telehealth interventions for chronic conditions, suggesting potential success for this approach in COPD rehabilitation.

Eligibility criteria

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 Criteria:

1. Secondary diagnosis of congestive heart failure that is severe as documented by active symptoms, New York Heart Association (NYHA) functional classification IV or left 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 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

Where this trial is running

Birmingham, Alabama and 14 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (RECRUITING)
• University of Iowa — Iowa City, Iowa, United States (RECRUITING)
• Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
• University of Maryland — College Park, Maryland, United States (RECRUITING)
• Boston VA Hospital — Boston, Massachusetts, United States (RECRUITING)
• HealthPartners Institute — Bloomington, Minnesota, United States (RECRUITING)
• Minnesota VA HealthCare System — Minneapolis, Minnesota, United States (RECRUITING)
• Northern Westchester Hospital/Northwell Health — Chappaqua, New York, United States (RECRUITING)
• Wake Forest University — Winston-Salem, North Carolina, United States (RECRUITING)
• Cincinnati VA Hospital — Cincinnati, Ohio, United States (RECRUITING)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (SUSPENDED)
• Baylor College of Medicine — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Surya P Bhatt, MD, MSPH — University of Alabama at Birmingham
• Study coordinator: Surya P Bhatt, MD, MSPH

Conditions: Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Rehabilitation, Telehealth