Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling
ImPReSS-COPD
2 other identifiers
interventional
305
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Feb 2023
Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedDecember 12, 2025
March 1, 2025
3 years
May 24, 2022
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Pulmonary Rehabilitation (PR) sessions: Completion of ≥6 PR sessions within 6 months of randomization
6 months
Secondary Outcomes (3)
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
Other Outcomes (16)
Change in Modified Medical Research Council (mMRC) dyspnea scale from randomization to 6 months
6 months
Change in Clinical COPD Questionnaire (CCQ) from randomization to 6 months
6 months
Change in Hospital Anxiety and Depression Scale (HADS) from randomization to 6 months
6 months
- +13 more other outcomes
Study Arms (3)
Enhanced usual care
NO INTERVENTIONEnhanced usual care describes a process in which automated surveillance is used to identify individuals experiencing a COPD exacerbation. This is followed by direct outreach - either through in-person visits while a patient is hospitalized, or by mail and telephone in the outpatient setting, to facilitate referral to PR. Subjects randomized to this arm will be given a pamphlet describing the benefits of PR.
Enhanced usual care + Storytelling
ACTIVE COMPARATORSubjects randomized to the eUC + Storytelling intervention will view the video narrative(s) of one or more individuals with COPD who has overcome similar barriers and has attended a program of PR. Subjects will be shown the first chapter of the story immediately after randomization and will receive email and/or text messages to prompt viewing of subsequent chapters at 2 weeks, 1 month, 2 months, 3 months and 5 months. Emails and text messages will include a link to a REDCap document that contains a set of embedded video clips representing the next chapter in each storyteller's narrative.
Enhanced usual care + Peer support
ACTIVE COMPARATORSubjects randomized to the eUC + Peer support intervention will be matched with a peer coach of the same gender, race, and approximate age. For those enrolled during a hospitalization, coaches will be instructed to attempt the initial phone contact prior to the patient's discharge; for patients enrolled after an ED visit or outpatient exacerbation, coaches will be instructed to contact the patients within 72 hours of randomization. Peer coaches will be asked to complete at least one call each week during months 1-2, biweekly calls during months 3-4, and monthly calls during months 5-6. Coaches will be asked to follow a conversation guide, provided during the initial training, to structure phone conversations with their paired patient.
Interventions
Video narratives of an individual with lived experience with COPD and Pulmonary Rehabilitation describing their journey through Pulmonary Rehabilitation
Telephonic Peer Coaching from an individual with lived experience with COPD and Pulmonary Rehabilitation trained in motivational interviewing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baystate Medical Centerlead
- University of Michigancollaborator
- COPD Foundationcollaborator
- University of Massachusetts, Worcestercollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Baystate Health
Springfield, Massachusetts, 01199, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Lindenauer, MD, MSc
Baystate Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes will be collected by a member of the research staff blinded to participant treatment arm
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 1, 2022
Study Start
February 24, 2023
Primary Completion
February 28, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
December 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- We will share deidentified IPD based on our criteria within 3 months after publication of our study results in scientific journals without any time limit to share thereafter.
- Access Criteria
- Access will be based on receipt of research question/s and analysis strategies planned by a researcher. Approval to access the deidentified IDP will be granted to the researcher if deemed relevant by the study PI.
We will share deidentified individual participant data upon receipt and approval of research question and analysis plan from a researcher; or for teaching purposes.