Clinical trial NCT05119556: Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease
Official title: Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Pulmonary Rehabilitation
Telehealth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-11-15
Enrollment: 768
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 52 week, prospective, randomized controlled, phase 3, multi-center clinical trial.
Primary purpose: TREATMENT

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 14 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.

Eligibility criteria: Inclusion Criteria:

1. Age 40 or greater
2. Clinical diagnosis of COPD
3. Hospitalized for acute exacerbation of COPD.
4. Be willing to adhere to trial and follow-up procedures and give informed consent

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

Primary outcomes:
measure: All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation
timeFrame: 30 days
measure: Change in St. George's Respiratory Questionnaire
timeFrame: 13 weeks
measure: Change in six-minute walk distance
timeFrame: 13 weeks
measure: Change in the University of California, San Diego Shortness of Breath Questionnaire
timeFrame: 13 weeks
measure: Cost Savings
timeFrame: 30 days
measure: Cost per Quality Adjusted Life Year Gained
timeFrame: 52 weeks
Secondary outcomes:
measure: 90-days all cause readmission rate
timeFrame: 13 weeks
measure: The adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 13 weeks
measure: Change in COPD Assessment Test score
timeFrame: 13 weeks
measure: Change in 30-second Sit-to-Stand Test
timeFrame: 13 weeks
measure: Change in the Clinical visit-PROactive Physical Activity Score
timeFrame: 13 weeks
measure: Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy
timeFrame: 13 weeks
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: 13 weeks
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: 13 weeks
measure: Change in The modified Medical Research Council score
timeFrame: 13 weeks
Other outcomes:
measure: 12-month all-cause hospitalizations
timeFrame: 52 weeks
measure: Change in COPD Assessment Test score
timeFrame: 52 weeks
measure: Change in 30-second Sit-to-Stand Test
timeFrame: 52 weeks
measure: Change in Clinical visit-PROactive Physical Activity Score
timeFrame: 52 weeks
measure: Change in Pulmonary Rehabilitation Adapted Index of Self-Efficacy
timeFrame: 52 weeks
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: 52 weeks
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: 52 weeks
measure: Change in The modified Medical Research Council score
timeFrame: 52 weeks
measure: Change in St. George's Respiratory Questionnaire
timeFrame: 52 weeks
measure: Change in six-minute walk distance
timeFrame: 52 weeks
measure: Change in University of California, San Diego Shortness of Breath Questionnaire score
timeFrame: 52 weeks
measure: All-cause mortality
timeFrame: 52 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Boston VA Hospital
state: Massachusetts
city: Bloomington
country: United States
facility: HealthPartners Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota VA HealthCare System
state: Minnesota
city: Chappaqua
country: United States
facility: Northern Westchester Hospital/Northwell Health
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: Surya P Bhatt, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: