Overview
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 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.
Principal investigator
Eligibility criteria
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
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