A Feasibility Study of a Chronic Pain Self-management Intervention for Older Adults Incorporating Podcasts and Patient Priorities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Pain Interference 6-item Subscale From PROMIS-43 Adult Profile
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: STEP-UP (Behavioral)
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.
Outcomes
Primary Outcomes
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
- Global Impression of Change in Pain(8 weeks from baseline)
- Global Impression of Change in Functioning(8 weeks from baseline)
- Participant Satisfaction(8 weeks from baseline)
- Engagement as Measured by Number of Sessions Completed(8 weeks from baseline)
Investigators
Mary Janevic
Research Associate Professor
University of Michigan