Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Behavioral: Video Telehealth Pulmonary Rehabilitation
- Registration Number
- NCT05119556
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 768
- Age 40 or greater
- Clinical diagnosis of COPD
- Hospitalized for acute exacerbation of COPD.
- Be willing to adhere to trial and follow-up procedures and give informed consent
- 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
- 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.
- Primary diagnosis of COVID pneumonia. Individuals with incidentally detected COVID or persistently positive for COVID but deemed to be convalescent will not be excluded.
- Active cancers on chemotherapy or radiation therapy
- Immunosuppressed states predisposing to frequent hospitalizations including uncontrolled HIV/AIDS
- Active or recent (within 1 month) myocardial infarction
- Angina not well-controlled by medication
- Unstable cardiac arrhythmias, atrial or ventricular
- Supplemental oxygen requirement greater than 5 liters per minute at either rest or with exertion
- Significant cognitive dysfunction, including dementia, that in opinion of investigator would impair ability to safely or effectively engage in study protocol
- Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice
- Currently enrolled in and participating in pulmonary rehabilitation
- Treatment with chronic or newly initiated home ventilatory support. Those on in-patient short-term non-invasive ventilation will not be excluded.
- Special patient groups such as prisoners and institutionalized patients
- Participants with musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program
- Current participation in any other interventional clinical trial
- Inability to understand and speak English during exercise sessions
- Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Video Telehealth Pulmonary Rehabilitation Video Telehealth Pulmonary Rehabilitation In addition to standard of care, participants will be asked to participate in rehabilitation sessions administered at home via live videoconferencing for approximately 60 minutes a session, three times a week. A total of 36 sessions will be planned to be completed by week 13 post-discharge. Exacerbations and health status will be ascertained every 4-weeks for 13 weeks.
- Primary Outcome Measures
Name Time Method All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation 30 days Hospitalizations will be ascertained via weekly phone calls. Hospitalization for any reason will be considered a primary event when it occurs within the first 30 days after index hospitalization.
Change in six-minute walk distance 13 weeks The six-minute walk test is an assessment of functional capacity, and is the distance walked in 6 minutes. The minimum clinically important difference (MCID) for COPD is 26 m.
Change in St. George's Respiratory Questionnaire 13 weeks The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. It consists of 40 questions, and scores range from 0 to 100, with higher scores indicating worse quality of life. The minimum clinically important difference (MCID) is 4 units.
Cost Savings 30 days Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.
Change in the University of California, San Diego Shortness of Breath Questionnaire 13 weeks The University of California, San Diego Shortness of Breath Questionnaire (SOBQ) is a 24-question, self-administered questionnaire which rates dyspnea associated with activities of daily living. Scores range from 0 to 120, with higher scores indicating greater dyspnea. The minimum clinically important difference (MCID) is 5.
Cost per Quality Adjusted Life Year Gained 52 weeks Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios.
- Secondary Outcome Measures
Name Time Method 90-days all cause readmission rate 13 weeks Hospitalizations will be ascertained by healthcare utilization questionnaire at the weekly phone calls.
The adverse events (AEs) and serious adverse events (SAEs) 13 weeks Safety of video telehealth PR intervention as determined by adverse events (AEs) and serious adverse events (SAEs)
Change in COPD Assessment Test score 13 weeks The COPD Assessment Test (CAT) survey is a validated, short (8-item) and simple patient completed questionnaire, and measures the health status of patients with COPD. This score is responsive to interventions such as pulmonary rehabilitation with a minimum clinically important difference (MCID) of 2 units.
Change in 30-second Sit-to-Stand Test 13 weeks The 30-second Sit-to-Stand test is an assessment of skeletal muscle dysfunction, leg strength and endurance. Scores range from 4 to 14, depending on age and sex, and higher scores indicate higher levels of functioning. The minimum clinically important difference (MCID) is 2.
Change in the Clinical visit-PROactive Physical Activity Score 13 weeks The Clinical visit-PROactive Physical Activity in COPD (C-PPAC) questionnaire will be used to generate scores for amount of physical activity, difficulty with physical activity and total physical activity experience. C-PPAC scores will be calculated by combining questionnaire items with two variables from activity monitors (steps/day and vector magnitude units (VMU)/min). Scores range from 0 to 100, where higher numbers indicate a better score. The minimum clinically important difference (MCID) is 6 for the amount and difficulty scores and 4 for the total score.
Change in Pittsburgh Sleep Quality Index 13 weeks The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval. It has 7 components (sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction) that are each scored from 0 to 3 for a total PSQI score of 0 to 21, with higher scores indicating worse sleep quality. The minimum clinically important difference (MCID) is 3 units.
Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy 13 weeks The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool is a 15-item disease-specific questionnaire that measures pulmonary rehabilitation-specific self-efficacy. The score ranges from 15 to 60, with higher scores indicating high levels of self-efficacy. The minimum clinically important difference (MCID) is 1.5 units.
Change in Hospital Anxiety and Depression Scale 13 weeks The Hospital Anxiety and Depression Scale (HADS) will be used to measure symptoms of anxiety and depression. The HADS contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, with maximum scores of 21 for anxiety and depression. The minimum clinically important difference (MCID) is 1.5 units.
Change in The modified Medical Research Council score 13 weeks The modified Medical Research Council (mMRC) has 5 questions that assess dyspnea in a graded fashion and quantify symptoms in COPD. The minimum clinically important difference (MCID) is 0.7.
Trial Locations
- Locations (14)
Northern Westchester Hospital/Northwell Health
🇺🇸Chappaqua, New York, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Maryland
🇺🇸College Park, Maryland, United States
Boston VA Hospital
🇺🇸Boston, Massachusetts, United States
HealthPartners Institute
🇺🇸Bloomington, Minnesota, United States
Minnesota VA HealthCare System
🇺🇸Minneapolis, Minnesota, United States
Cincinnati VA Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States