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NCT05119556 | RECRUITING | Chronic Obstructive Pulmonary Disease

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

University of Alabama at Birmingham

Information provided by (Responsible Party):

Surya P Bhatt

Brief 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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

Video Telehealth Pulmonary Rehabilitation

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 768 participants
Masking : SINGLE
Masking Description : A blinded adjudication committee will evaluate all hospitalizations.
Primary Purpose : TREATMENT
Official Title : Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)
Actual Study Start Date : 2022-06-28
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2028-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease

Location Details

NCT05119556

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35233

RECRUITING

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Maryland

University of Maryland

College Park, Maryland, United States, 20742

RECRUITING

United States, Massachusetts

Boston VA Hospital

Boston, Massachusetts, United States, 02130

RECRUITING

United States, Minnesota

HealthPartners Institute

Bloomington, Minnesota, United States, 55440

RECRUITING

United States, Minnesota

Minnesota va Healthcare System

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, New York

Northern Westchester Hospital/Northwell Health

Chappaqua, New York, United States, 10514

RECRUITING

United States, North Carolina

Wake Forest University

Winston-Salem, North Carolina, United States, 27109

RECRUITING

United States, Ohio

Cincinnati VA Hospital

Cincinnati, Ohio, United States, 45220

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Pennsylvania

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19122

SUSPENDED

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

RECRUITING

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030