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Completed

NCT Number: NCT06185101

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

STEP-UP

Behavioral

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: Support, Training, and Education for Pain self-management, Using Podcasts

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)).

  2. Global Impression of Change in Functioning

    Time frame: 8 weeks from baseline

    How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).

  3. Engagement as Measured by Number of Sessions Completed

    Time frame: 8 weeks from baseline

    Number of sessions out of 6 completed 8 weeks from baseline

  4. Participant Satisfaction

    Time frame: 8 weeks from baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)
  • Weill Medical College of Cornell University
  • Western Wayne Family Health Centers

Registry information

Official study title

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

Acronym: STEP-UP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2023
Registry last updated
Jan 26, 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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