Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Feasibility Study of a Chronic Pain Self-management Intervention for Older Adults Incorporating Podcasts and Patient Priorities

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: STEP-UP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEP-UP intervention group<br>Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker. | Behavioral: STEP-UP<br>* 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.<br>* Other names: Support, Training, and Education for Pain self-management, Using Podcasts;|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile | 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. | Baseline, 8 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Impression of Change in Pain | How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). | 8 weeks from baseline | 
| Global Impression of Change in Functioning | How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)). | 8 weeks from baseline | 
| Engagement as measured by number of sessions completed | Number of sessions out of 7 completed 8 weeks from baseline | 8 weeks from baseline | 
| Participant Satisfaction | 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 |