Pulmonary Rehabilitation for Rural Patients With COPD

Mayo Clinic

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease (COPD

Treatments: Behavioral: Pulmonary rehabilitation program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06847061

1R01NR021634-01 (U.S. NIH Grant/Contract)

24-008332

Details and patient eligibility

About

The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.

Enrollment: 306 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 40 years of age or older
• Physician-diagnosed COPD
• Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
• mMRC score>=1
• English Speaking

Exclusion Criteria

• Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
• Cognitive impairment or inability to understand and follow instructions.
• Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.
• Traditional center-based PR was completed within 3 months of initial study recruitment.
• Transition to hospice or end-of-life care at the time of screening.
• Acute exacerbation at the time of screening.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.

Treatment:

Behavioral: Pulmonary rehabilitation program

Waitlist Control

Experimental group

Description:

Subjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period.

Treatment:

Behavioral: Pulmonary rehabilitation program