Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
2 other identifiers
interventional
301
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Jun 2022
Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedStudy Start
First participant enrolled
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2028
ExpectedApril 13, 2026
April 1, 2026
3.7 years
October 26, 2021
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
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.
30 days
Change in St. George's Respiratory Questionnaire
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.
13 weeks
Change in six-minute walk distance
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.
13 weeks
Change in the University of California, San Diego Shortness of Breath Questionnaire
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.
13 weeks
Cost Savings
Cost saving will be estimated by comparing costs of the intervention and savings resulting from readmission reduction within 30 days.
30 days
Cost per Quality Adjusted Life Year Gained
Cost-effectiveness will be calculated by comparing Telehealth PR with Standard of Care using incremental cost-effectiveness ratios.
52 weeks
Secondary Outcomes (9)
90-days all cause readmission rate
13 weeks
The adverse events (AEs) and serious adverse events (SAEs)
13 weeks
Change in COPD Assessment Test score
13 weeks
Change in 30-second Sit-to-Stand Test
13 weeks
Change in the Clinical visit-PROactive Physical Activity Score
13 weeks
- +4 more secondary outcomes
Other Outcomes (12)
12-month all-cause hospitalizations
52 weeks
Change in COPD Assessment Test score
52 weeks
Change in 30-second Sit-to-Stand Test
52 weeks
- +9 more other outcomes
Study Arms (2)
Standard of Care
NO INTERVENTIONParticipants will receive standard of care for COPD management per local guidance. In addition, they will receive 4-weekly phone calls for 13 weeks post discharge to inquire about health status and exacerbations.
Video Telehealth Pulmonary Rehabilitation
ACTIVE COMPARATORIn 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.
Interventions
Participant will be asked to exercise 3 times a week at their home for 60 minutes each session, via live two-way videoconferencing using a data-enabled smart phone or similar device. A total of 36 sessions will be administered over 13 weeks post-discharge. Sessions will be administered by exercise physiologists located at the University of Alabama at Birmingham. Each session will be scheduled with up to three other participants at a time to mimic group sessions as delivered at center-based pulmonary rehabilitation programs. Exercise sessions will include aerobics, strength or resistance training, breathing exercises, and education sessions. The exercise plans will be tailored according to the participants' baseline exercise tolerance as determined by an initial six minute walk test and their answers to the questionnaires at the baseline visit.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Maryland
College Park, Maryland, 20742, United States
Boston VA Hospital
Boston, Massachusetts, 02130, United States
HealthPartners Institute
Bloomington, Minnesota, 55440, United States
Minnesota VA HealthCare System
Minneapolis, Minnesota, 55455, United States
Northern Westchester Hospital/Northwell Health
Chappaqua, New York, 10514, United States
Wake Forest University
Winston-Salem, North Carolina, 27109, United States
Cincinnati VA Hospital
Cincinnati, Ohio, 45220, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19122, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surya P Bhatt, MD, MSPH
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A blinded adjudication committee will evaluate all hospitalizations.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 15, 2021
Study Start
June 28, 2022
Primary Completion
February 28, 2026
Study Completion (Estimated)
February 27, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available 12 months after study completion.
- Access Criteria
- With approval from the Publications and Presentations Committee
De-identified data will be shared through a password-protected website maintained without cost to researchers after requests are vetted by the principal investigators at UAB. The investigators will make the data and associated documentation available to users under a data sharing agreement that accounts for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Users must also agree to the conditions of use governing access to the public release of data, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Research data will be de-identified to prevent disclosure of personal identifiers and presented in a summary format.