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

Chronic Pain Clinical Trial

— STEP-UP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185101
• Other study ID #: HUM00240183
• Secondary ID: 5P30AG022845-20
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Mary Janevic, PhD
• Phone: 734 647 3194
• Email: mjanevic[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• STEP-UP
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA), Weill Medical College of Cornell University, Western Wayne Family Health Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Engagement as measured by number of sessions completed	Number of sessions out of 7 completed 8 weeks from baseline	8 weeks from baseline
Secondary	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