Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05399056
• Lead Sponsor: Baystate Medical Center

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) affects approximately 16 million Americans and is characterized by recurrent exacerbations that lead to 1.5 million Emergency Department visits and 700,000 hospitalizations annually. Pulmonary rehabilitation (PR) is a structured program of exercise and self-management support that has been proven to relieve shortness of breath and increase quality of life when initiated after an exacerbation, but unfortunately, few eligible patients participate. This project will compare the effectiveness of two novel strategies - one involving video narratives of other patients telling their story of how they overcame challenges and completed PR, the other involving telephonic peer coaching with an individual with lived experience - to enhanced usual care, and to each other, at increasing patient participation in PR after an exacerbation.

Detailed Description

Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) lead to roughly 1.5 million ED visits and 700,000 hospitalizations annually. Recovery is slow and accompanied by high levels of acute care utilization and mortality. Pulmonary Rehabilitation (PR) is a structured program of exercise and self-management support that has been shown to relieve dyspnea and improve quality of life. Clinical guidelines recommend PR for patients with stable COPD and after an exacerbation. Unfortunately, even when referred by physicians, research has shown that few patients who might benefit from PR ever begin treatment.

The primary goal of this project is to identify effective strategies for promoting and sustaining participation in PR. Peer Support involves pairing a patient with a trained peer from a similar background, and facing similar health challenges, who has completed PR. There is a growing body of evidence demonstrating the feasibility, acceptability, and effectiveness of telephonic peer support for chronic disease management. Narrative interventions, or 'Storytelling', are novel approaches for changing attitudes and behaviors of patients that involve creating and disseminating videos narrated by individuals with lived experience with the same condition or facing the same treatment. Storytelling interventions have been shown to help individuals achieve better blood pressure control, and storytelling is being studied in a variety of other clinical contexts.

In the R61 Phase, the investigators will recruit and train a cohort of peer coaches in behavior change techniques, and will recruit a diverse group of storytellers, capture their narratives on video, and create a library of 6-8 powerful stories. The investigators will finalize the protocol, trial infrastructure, and pilot the recruitment strategy. During the R33 Phase, the investigators will recruit 305 adults treated for exacerbation of COPD, and randomize them to 1) Enhanced "Usual Care" (eUC); 2) eUC + Storytelling; or 3) eUC + Peer Support. The investigators will evaluate the effectiveness of each strategy compared to eUC, and to each other, at promoting participation in PR at 6 months.

Using a mixed-methods approach, the investigators will evaluate intervention acceptability, sustainability, and cost, from the perspectives of the patients and peer coaches as well as PR program staff and hospital leadership. This information will be uses to refine the strategies and to disseminate an implementation package that will enable other PR programs to adopt these approaches.

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2023-02-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

• 40 years or older
• Received treatment for COPD exacerbation in either inpatient or outpatient setting
• Referred for pulmonary rehabilitation
• Ability to understand and communicate in English
• Willingness to participate in calls with peer coach and to view storytelling videos
• Working phone

Exclusion Criteria

• Unwilling to attend PR
• Not eligible for PR based on spirometry or other clinical contraindications as determined by PR staff
• Currently enrolled in, or completion of 12 or more sessions of PR in the past
• Comfort measures only or Hospice care
• Resident of long-term care facility
• Unable or unwilling to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Pulmonary Rehabilitation (PR) sessions: Completion of ≥6 PR sessions within 6 months of randomization	6 months

Secondary Outcome Measures

Name	Time	Method
Any attendance (yes/no) at PR within 6 months of randomization.	6 months
Total number of PR sessions completed within 6 months of randomization.	6 months
Time to first PR session attended	6 months

Trial Locations

Locations (1)

Baystate Health; 🇺🇸 Springfield, Massachusetts, United States