- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06185101
Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial (STEP-UP)
January 7, 2026 updated by: Mary Janevic, University of Michigan
A Feasibility Study of a Chronic Pain Self-management Intervention for Older Adults Incorporating Podcasts and Patient Priorities
This randomized Stage 1 pilot trial tests the feasibility of a community health worker (CHW) delivered chronic pain self-management intervention for older adults ("STEP-UP"; Support, Training, and Education for Pain Self-Management - Using Podcasts) in a primary care setting.
A total of 40 participants aged 50+ with high-impact chronic pain will be randomized to intervention or control groups.
The STEP-UP intervention will feature an educational podcast series teaching core pain self-management skills.
Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period.
The Community Health Worker will guide participants in a modified Patient Priorities of Care approach to help them identify their values and priorities and develop goals that reflect these.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age > 50 years
- Have a mobile or landline phone
- Report high-impact chronic musculoskeletal pain (defined as pain in muscles or joints for > 3 months "most days" or "every day" on a scale of never, some days, most days, or every day) AND their pain limited life or work activities over the past 3 months "most days" or "every day"
- Have not participated in another chronic pain self-management intervention in the last 5 years.
- Able to converse comfortably in English
Exclusion Criteria:
- Serious acute illness or hospitalization in the last month;
- Planned major surgery in the next three months that would interfere with program participation (e.g., knee or hip replacement)
- Severe cognitive impairment or other severe physical or psychiatric disorder judged by the study team to pose a significant barrier to participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STEP-UP intervention group
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
|
The STEP-UP chronic pain self-management intervention (Support, Training, and Education for Pain Self-Management - Using Podcasts) will feature an educational podcast series teaching core pain self-management skills.
Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period.
The Community Health Worker will guide participants in a modified Patient Priorities of Care (PPC) approach to help them identify their values and priorities and develop goals that reflect these.
Other Names:
|
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No Intervention: Control group
Members of the control group will not initially receive the STEP-UP intervention.
After completing the 8-week follow-up telephone survey, individuals in the control group will be invited to take part in the STEP-UP intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Interference 6-item Subscale From PROMIS-43 Adult Profile
Time Frame: Baseline, 8 weeks from baseline
|
Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference).
Scores are converted to a standardized T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population.
A higher score means more of the concept being measured.
Change scores are calculated as [8 week score] - [baseline score]; therefore, a greater negative value means a greater reduction in pain interference.
|
Baseline, 8 weeks from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Impression of Change in Pain
Time Frame: 8 weeks from baseline
|
How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)).
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8 weeks from baseline
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Global Impression of Change in Functioning
Time Frame: 8 weeks from baseline
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How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).
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8 weeks from baseline
|
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Participant Satisfaction
Time Frame: 8 weeks from baseline
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Items ask about overall satisfaction with the program, e.g., whether participation increased understanding of pain management (1= Strongly Disagree to 5= Strongly Agree).
A higher score indicates higher patient satisfaction.
|
8 weeks from baseline
|
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Engagement as Measured by Number of Sessions Completed
Time Frame: 8 weeks from baseline
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Number of sessions out of 6 completed 8 weeks from baseline
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8 weeks from baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2024
Primary Completion (Actual)
January 29, 2025
Study Completion (Actual)
January 29, 2025
Study Registration Dates
First Submitted
December 14, 2023
First Submitted That Met QC Criteria
December 14, 2023
First Posted (Actual)
December 29, 2023
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00240183
- 5P30AG022845-20 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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