This is a prospective randomized controlled phase 2b multicenter trial comparing a real-time video telehealth PR intervention with usual medical care, with the following Specific Aims: (1) To determine if a video telehealth PR intervention reduces 30-day all-cause readmissions in patients hospitalized for acute exacerbation of COPD compared with standard of care, (2) To evaluate the effects of the video telehealth PR intervention on dyspnea, functional capacity, and respiratory-quality of life in COPD post hospital discharge, and (3) To evaluate the cost-effectiveness of the video telehealth PR on program compared with usual care for the reduction of COPD readmissions. We will enroll 768 COPD patients at hospitalization and randomize them in a 1:1 fashion at the 7-day visit to receive video telehealth PR or usual care for 3 months, and compare 30-day readmission rates. Video telehealth PR will comprise all components of traditional PR including aerobic exercise, resistance training, breathing exercises, nutrition, self-efficacy, and disease education. We will assess 90-day and 12-month readmission rates as secondary outcomes. Dr. Kalhan will serve as the site-PI at Northwestern University. He and his team will be responsible for screening, recruiting, consenting, and randomizing participants into the trial. He will also be responsible for the collection and timely and accurate submission of all trial data required by the study protocol. In performing these services, Dr. Kalhan and his team agree to expend their best efforts in obtaining informed consent, collecting and submitting participant information, and performing tests and procedures as outlined in the study protocol. He will report adverse events occurring during the trial to the DCC in a timely fashion and maintain appropriate documentation. He and his team will participate in investigator/coordinator training, participate in steering committee calls monthly and more often as needed, attend meetings, and academic publications stemming from the work.
|Effective start/end date||9/1/21 → 7/31/27|
- University of Alabama at Birmingham (000530409-SC006/1UG3HL155806-01A1)
- National Heart, Lung, and Blood Institute (000530409-SC006/1UG3HL155806-01A1)
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