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Clinical Trial 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.


Clinical Trial Description

This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial (n=768 at 10 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 7 (-2 to +3) 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. The control arm will receive additional weekly phone calls to ascertain any exacerbations. Questionnaires and assessments of function will be administered at the baseline 7 day visit and at completion of the intervention at 13 weeks. Participants in both arms will be contacted 4-weekly throughout the intervention period to ascertain healthcare utilization. Questionnaires and assessments of function will be repeated at the end of the follow-up period at 52 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05119556
Study type Interventional
Source University of Alabama at Birmingham
Contact Surya P Bhatt, MD, MSPH
Phone 205-934-5555
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date June 1, 2022
Completion date August 31, 2027

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