Telehealth Pulmonary Rehabilitation for COPD

Recruiting at 13 trial locations

Overseen By Elizabeth Plan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe heart failure, Asthma, Active cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 50

Duration: 12 weeks

768 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Video Telehealth Pulmonary Rehabilitation, Telehealth Pulmonary Rehabilitation, Virtual Pulmonary Rehabilitation, Telerehabilitation for COPD?

Research shows that telehealth pulmonary rehabilitation for COPD patients is feasible and can provide positive clinical and social benefits, making it a promising alternative to traditional in-person programs, especially when access to such programs is limited. ^{1 2 3 4 5}

Is telehealth pulmonary rehabilitation safe for people with COPD?

Research shows that telehealth pulmonary rehabilitation is safe for people with COPD, with no major adverse events reported in studies. ^{4 5 6 7 8}

How is the treatment 'Video Telehealth Pulmonary Rehabilitation' different from other treatments for COPD?

Video Telehealth Pulmonary Rehabilitation is unique because it allows COPD patients to participate in rehabilitation programs from home using video technology, making it more accessible and convenient compared to traditional in-person rehabilitation sessions. This approach can enhance patient participation and provide clinical and social benefits, especially for those who have limited access to conventional rehabilitation centers. ^{1 2 3 4 5}

Research Team

Surya Bhatt, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults aged 40-85 hospitalized with a flare-up of COPD, willing to follow the study plan and give consent. Excluded are those with terminal illnesses, severe heart failure, cognitive issues preventing safe participation, non-English speakers, certain immunosuppressed states or active cancers, recent heart attacks or on invasive ventilation.

Inclusion Criteria

I am in the hospital for a severe COPD flare-up.

I have been diagnosed with COPD.

I am between 40 and 85 years old.

Exclusion Criteria

I have a terminal illness and/or am receiving hospice care.

I have severe heart failure with significant symptoms or very poor heart pump function.

I am currently receiving chemotherapy or radiation for my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive video telehealth pulmonary rehabilitation sessions three times a week for 12 weeks

12 weeks

36 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 13 weeks and 52 weeks

39 weeks

Monthly phone calls, assessments at 13 and 52 weeks

Treatment Details

Interventions

• Video Telehealth Pulmonary Rehabilitation

Trial Overview The study tests if video telehealth pulmonary rehabilitation can reduce hospital readmissions in COPD patients compared to standard care. It will assess effectiveness and safety of this method and its cost-effectiveness.

Participant Groups

Group I: Standard of Care Active Control 1 Intervention

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.

Group II: Video Telehealth Pulmonary Rehabilitation Active Control 1 Intervention

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.

Video Telehealth Pulmonary Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Video Telehealth Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)

Approved in European Union as Telerehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Other chronic lung diseases

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Tele-pulmonary rehabilitation has emerged as a feasible and effective alternative to traditional in-person pulmonary rehabilitation for patients with chronic obstructive pulmonary disease (COPD), especially during the COVID-19 pandemic.

A hybrid model combining both in-person and remote components may be the best approach for delivering pulmonary rehabilitation in the future, but further high-quality studies and collaboration are needed to optimize this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. Wen, J., Milne, S., Sin, DD.[2023]

Telerehabilitation for COPD patients is a safe and effective alternative to conventional pulmonary rehabilitation, showing no inferior results in improving functional exercise capacity and quality of life across ten studies involving 1492 participants.

Despite the positive outcomes, the study highlights a significant variability in telerehabilitation methods, indicating a need for a standardized approach to therapy and technology use in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Home-Based Training with Internet Telehealth Guidance in COPD Patients Entering Pulmonary Rehabilitation: A Systematic Review. Hartman, M., Mináriková, J., Batalik, L., et al.[2023]

Telehealthcare significantly improves physical activity levels in patients with chronic obstructive pulmonary disease (COPD), with an average increase of 64.7 minutes compared to standard care, based on a systematic review of 9 studies involving 982 patients.

However, telehealthcare did not show significant differences in physical capacity or dyspnea levels, indicating that while it can enhance activity, it may not directly improve other aspects of COPD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Lundell, S., Holmner, Å., Rehn, B., et al.[2022]

Telehealth with video components for real-time pulmonary rehabilitation is feasible and acceptable for COPD patients, suggesting it can effectively support their rehabilitation at home.

The review of seven studies indicates that telehealth can offer clinical and social benefits for COPD patients, but there remains a knowledge gap regarding its overall effectiveness and acceptance in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease at Home Using Telehealth: A Review of the Literature. Almojaibel, AA.[2020]

A telehealth-based maintenance program for COPD patients after intensive pulmonary rehabilitation was found to be feasible and safe, but it did not show significant superiority over usual care in sustaining physical benefits like the 6-minute walk distance.

While the tele-rehabilitation group did experience some improvements in quality of life measures, such as mental health scores, these were not linked to compliance, and acute exacerbations negatively impacted long-term physical function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial. Galdiz, JB., Gómez, A., Rodriguez, D., et al.[2021]

The study successfully implemented a province-wide tele-pulmonary rehabilitation (tele-PR) program for individuals with COPD, demonstrating high accessibility and feasibility with over 70% program completion and no major adverse events reported.

Both tele-PR and standard PR showed significant improvements in physical performance and quality of life, with tele-PR participants maintaining better long-term improvements in quality of life scores compared to those in standard PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accessibility, Feasibility, and Safety of a Standardized Community-based Tele-Pulmonary Rehab Program for Chronic Obstructive Pulmonary Disease: A 3-Year Real-World Prospective Study. Alwakeel, AJ., Sicondolfo, A., Robitaille, C., et al.[2022]

A study involving 14 participants who completed an online pulmonary rehabilitation (PR) program showed significant improvements in various health outcomes, including physical performance and mental health measures, indicating that online PR can be effective for patients referred to traditional face-to-face programs.

Participants and staff reported that the online format allowed for better incremental progression of exercises and improved engagement, although educational sessions were perceived as less effective compared to in-person delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an online platform delivery of pulmonary rehabilitation for individuals with chronic respiratory disease. Lewis, A., Knight, E., Bland, M., et al.[2021]

Tele-rehabilitation (Tele-R) significantly improves exercise capacity and reduces dyspnea and COPD symptoms in patients compared to no rehabilitation, with improvements of 48 meters in the 6-minute walk test and reductions in dyspnea and COPD assessment scores, based on a meta-analysis of 758 COPD patients.

When compared to traditional center-based rehabilitation, Tele-R showed no significant differences in exercise capacity or symptom control, suggesting it is a valid alternative but highlighting the need for further research to optimize patient selection and Tele-R methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of respiratory tele-rehabilitation in COPD patients: Systematic review and meta-analysis. Ora, J., Prendi, E., Attinà, ML., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Home-Based Training with Internet Telehealth Guidance in COPD Patients Entering Pulmonary Rehabilitation: A Systematic Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Delivering Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease at Home Using Telehealth: A Review of the Literature. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Accessibility, Feasibility, and Safety of a Standardized Community-based Tele-Pulmonary Rehab Program for Chronic Obstructive Pulmonary Disease: A 3-Year Real-World Prospective Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of an online platform delivery of pulmonary rehabilitation for individuals with chronic respiratory disease. [2021]

8. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of respiratory tele-rehabilitation in COPD patients: Systematic review and meta-analysis. [2022]