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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ImPReSS-COPD Trial 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.Check my eligibility
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.See study design
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.
ImPReSS-COPD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated for a COPD flare-up.
Select...
I am 40 years old or older.
ImPReSS-COPD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Pulmonary Rehabilitation (PR) sessions: Completion of ≥6 PR sessions within 6 months of randomization
Secondary outcome measures
Any attendance (yes/no) at PR within 6 months of randomization.
Time to first PR session attended
Total number of PR sessions completed within 6 months of randomization.
Other outcome measures
Activation (Self Efficacy for Managing Chronic Diseases 6)
Change in Activation (Self Efficacy for Managing Chronic Diseases 6) from enrollment to 12 months - For Peer Coach subjects
Change in Clinical COPD Questionnaire (CCQ) from enrollment to 12 months- For Peer Coach subjects
+12 moreImPReSS-COPD 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
63 Previous Clinical Trials
43,968 Total Patients Enrolled
University of MichiganOTHER
1,797 Previous Clinical Trials
6,377,753 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
343 Previous Clinical Trials
986,305 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been referred for lung rehab.I am not a candidate for pulmonary rehabilitation based on my lung function tests.I have been treated for a COPD flare-up.I am willing to engage in calls with a peer coach and watch videos.I am receiving care focused on comfort or am in hospice.I am not willing to attend pulmonary rehabilitation.I am 40 years old or older.You have a phone that works.I have completed at least 12 sessions of pulmonary rehabilitation.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced usual care + Peer support
- Group 2: Enhanced usual care
- Group 3: Enhanced usual care + Storytelling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively seeking participants?
"According to the information on clinicaltrials.gov, enrollment for this specific medical trial is now closed as it was last updated on May 26th 2022. Nevertheless, there are still 477 other studies actively recruiting individuals at present."
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