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Peer Support & Storytelling for COPD (ImPReSS-COPD Trial)

N/A
Recruiting
Led By Peter Lindenauer, MD, MSc
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received treatment for COPD exacerbation in either inpatient or outpatient setting
40 years or older
Must not have
Comfort measures only or Hospice care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial 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.

Who is the study for?
This trial is for individuals over 40 with COPD who've been treated for an exacerbation and referred to pulmonary rehabilitation (PR). Participants must be willing to engage in peer coaching calls, watch storytelling videos, have a working phone, and communicate in English. Those not eligible or unwilling to attend PR, in hospice care, living in long-term facilities, or who have already completed significant PR are excluded.
What is being tested?
The study tests two strategies aimed at increasing participation in PR post-exacerbation: video narratives from patients sharing their experiences with overcoming challenges related to PR and telephonic peer coaching by someone familiar with COPD. These methods will be compared against each other and enhanced usual care.
What are the potential side effects?
Since the interventions involve non-medical approaches like storytelling and peer support via telephone calls rather than drugs or medical procedures, there are no direct physical side effects expected from participating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated for a COPD flare-up.
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am receiving care focused on comfort or am in hospice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Enhanced usual care + Peer supportActive Control1 Intervention
Subjects 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.
Group II: Enhanced usual careActive Control1 Intervention
Enhanced 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.
Group III: Enhanced usual care + StorytellingActive Control1 Intervention
Subjects 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.

Find a Location

Who is running the clinical trial?

Baystate Medical CenterLead Sponsor
66 Previous Clinical Trials
44,192 Total Patients Enrolled
University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,268 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
362 Previous Clinical Trials
992,415 Total Patients Enrolled
COPD FoundationOTHER
17 Previous Clinical Trials
238,005 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,638 Total Patients Enrolled
Peter Lindenauer, MD, MScPrincipal InvestigatorBaystate Health
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Enhanced usual care + Peer support Clinical Trial Eligibility Overview. Trial Name: NCT05399056 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Enhanced usual care + Peer support, Enhanced usual care, Enhanced usual care + Storytelling
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Enhanced usual care + Peer support Highlights & Side Effects. Trial Name: NCT05399056 — N/A
Enhanced usual care + Peer support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399056 — N/A
~119 spots leftby Feb 2026