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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pulmonary rehab exercises via video calls help people with COPD (a lung disease that makes breathing difficult) avoid hospital visits more effectively than the usual care plan. One group of participants will perform these exercises three times a week at home through live video sessions, while the other group will adhere to their regular COPD care plan with occasional phone check-ins. The trial seeks individuals who have been hospitalized due to a COPD flare-up and are willing to follow the study plan from home. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance the quality of life for COPD patients.

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 prior data suggests that video telehealth pulmonary rehabilitation is safe for COPD patients?

Research has shown that pulmonary rehabilitation through video calls is generally safe for individuals with long-term lung diseases like COPD. Studies have found that this type of rehab can significantly reduce hospital readmissions, indicating it is well-received by patients. No major reports of negative effects directly related to video call use for this rehab have emerged. It functions similarly to traditional pulmonary rehab, which is known for its safety and effectiveness. In this study, participants will conduct sessions at home using video, which may be more convenient and just as safe as clinic visits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about video telehealth pulmonary rehabilitation for COPD because it offers a unique delivery method that brings rehab sessions directly to patients' homes via live videoconferencing. This approach is distinct from traditional in-person rehab, making it more accessible, especially for those with mobility issues or living in remote areas. By integrating frequent, structured rehab sessions into the home environment, this method aims to improve patient adherence and outcomes. Plus, the convenience of telehealth could enhance monitoring and early intervention for exacerbations, potentially reducing hospital readmissions.

What evidence suggests that video telehealth pulmonary rehabilitation is effective for COPD?

Research has shown that pulmonary rehabilitation (PR) can greatly benefit individuals with long-term lung diseases like COPD. One study found that PR reduced hospital visits by 56% within about nine months after patients were discharged. This indicates that PR improves lung health and reduces the need for hospital readmissions. In this trial, participants in one arm will receive Video Telehealth Pulmonary Rehabilitation, which delivers PR through video calls. This approach makes access easier for many patients and may offer similar benefits. It is particularly useful for those unable to attend in-person sessions due to location or mobility issues. ^{1 2 3 4 6}

Who Is on the Research Team?

Surya Bhatt, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6701038/

Video Telehealth Pulmonary Rehabilitation Intervention in ... In this regard, pulmonary rehabilitation (PR) is associated with a 56% reduction in hospital readmission over a median duration of 9 months after discharge (5), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05119556

Study Details | NCT05119556 | Video Telehealth ... 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 ...

3. atsjournals.org atsjournals.org/doi/10.1164/rccm.202402-0392VP

Telehealth Pulmonary Rehabilitation: A Call for Minimum ... Pulmonary rehabilitation (PR) is a highly effective therapy for patients with chronic respiratory disease (1). PR is delivered most commonly at ...

4. heartandlung.org heartandlung.org/article/S0147-9563(24)00013-X/fulltext

Effectiveness of virtual reality-based therapy in pulmonary ... VRBT is suggested to be effective in increasing functional capacity, pulmonary function, and functional mobility in patients with COPD.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0147-9563(24)00013-X

Effectiveness of virtual reality-based therapy in pulmonary ... VRBT is suggested to be effective in increasing functional capacity, pulmonary function, and functional mobility in patients with COPD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8867356/

Video Telehealth Pulmonary Rehabilitation for Chronic ... The video sessions also incorporated education on disease management, monitoring for exacerbations, smoking cessation, diet, and appropriate inhaler techniques.