Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Video Telehealth Pulmonary Rehabilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05119556

IRB-300008210

1UG3HL155806-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 768 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

768 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Participants 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 Comparator group

Description:

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.

Treatment:

Behavioral: Video Telehealth Pulmonary Rehabilitation