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NCT Number: NCT05399056

Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location status: Recruiting

Location contact

Rajashree Kotejoshyer

CONTACT

[email protected]

9787618709

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephonic Peer Coaching

Behavioral

Telephonic Peer Coaching from an individual with lived experience with COPD and Pulmonary Rehabilitation trained in motivational interviewing

Storytelling

Behavioral

Video narratives of an individual with lived experience with COPD and Pulmonary Rehabilitation describing their journey through Pulmonary Rehabilitation

Primary outcomes

  1. Number of Pulmonary Rehabilitation (PR) sessions: Completion of ≥6 PR sessions within 6 months of randomization

    Time frame: 6 months

Secondary outcomes

  1. Any attendance (yes/no) at PR within 6 months of randomization.

    Time frame: 6 months

  2. Total number of PR sessions completed within 6 months of randomization.

    Time frame: 6 months

  3. Time to first PR session attended

    Time frame: 6 months

Other outcomes

  1. Change in Modified Medical Research Council (mMRC) dyspnea scale from randomization to 6 months

    Time frame: 6 months

  2. Change in Clinical COPD Questionnaire (CCQ) from randomization to 6 months

    Time frame: 6 months

  3. Change in Hospital Anxiety and Depression Scale (HADS) from randomization to 6 months

    Time frame: 6 months

  4. Activation (Self Efficacy for Managing Chronic Diseases 6)

    Time frame: 6 months

  5. Change in Medical Outcomes Survey (MOS) Social Support Survey from randomization to 6 months

    Time frame: 6 months

  6. Change in UCLA Loneliness Scale from randomization to 6 months

    Time frame: 6 months

  7. Total # of COPD Exacerbations

    Time frame: 6 months

  8. Total # of ED visits

    Time frame: 6 months

  9. Total # of Hospitalizations

    Time frame: 6 months

  10. Change in Modified Medical Research Council (mMRC) dyspnea scale from enrollment to 12 months - For Peer Coach subjects

    Time frame: 12 months

  11. Change in Clinical COPD Questionnaire (CCQ) from enrollment to 12 months- For Peer Coach subjects

    Time frame: 12 months

  12. Change in Activation (Self Efficacy for Managing Chronic Diseases 6) from enrollment to 12 months - For Peer Coach subjects

    Time frame: 12 months

  13. Change in Hospital Anxiety and Depression Scale (HADS) from enrollment to 12 months - For Peer Coach subjects

    Time frame: 12 months

  14. Change in UCLA Loneliness Scale from enrollment to 12 months - For Peer Coach subjects

    Time frame: 12 months

  15. Change in Satisfaction with life scale (SWLS) from enrollment to 12 months - For Peer Coach subjects

    Time frame: 12 months

  16. Breathlessness belief questionnaire

    Time frame: 6-months.

    11-item scale to measure activity avoidance due to dyspnea.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Hazelton

CONTACT

[email protected]

978-337-0340

Rajashree Kotejoshyer, ScD

CONTACT

[email protected]

978-761-8709

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Collaborators

  • COPD Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Massachusetts, Worcester
  • University of Michigan

Registry information

Acronym: ImPReSS-COPD

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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