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Telehealth Pulmonary Rehabilitation for COPD

N/A

Recruiting

Led By Surya P Bhatt, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized for acute exacerbation of COPD.

Clinical diagnosis of COPD

Must not have

Participants with any terminal medical illnesses as diagnosed by a physician, and/or on hospice

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of a real-time video telehealth intervention for pulmonary rehabilitation vs. standard care for COPD patients hospitalized for an exacerbation. The study will look at readmission rates and respiratory morbidity, as well as the cost-effectiveness of the intervention.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves exercise through video telehealth rather than medication, side effects may include typical risks associated with physical activity such as muscle strain or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with COPD.

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I am between 40 and 85 years old.

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I am in the hospital for a sudden worsening of my COPD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am currently receiving chemotherapy or radiation for my cancer.

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I have a condition like uncontrolled HIV that often requires hospital stays.

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My chest pain is not well-managed with medication.

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I cannot understand or speak English during exercise sessions.

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I am currently in a lung rehab program.

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I am on dialysis therapy.

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I do not have irregular heartbeats that are severe or uncontrolled.

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I cannot join an exercise program due to physical health issues.

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I need more than 5 liters of oxygen per minute, whether I'm resting or moving.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-cause hospitalization within 30 days post discharge for an index admission for COPD exacerbation

Change in the University of California, San Diego Shortness of Breath Questionnaire

Cost Savings

+1 more

Secondary study objectives

90-days all cause readmission rate

Change in the Clinical visit-PROactive Physical Activity Score

The adverse events (AEs) and serious adverse events (SAEs)

Other study objectives

12-month all-cause hospitalizations

All-cause mortality

Change in 30-second Sit-to-Stand Test

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard of CareActive Control1 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 RehabilitationActive Control1 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.

0 / 15Eligibility criteria met