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Active Not RecruitingNCT05278234

STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults

An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-Management Support for Vulnerable Older Adults

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
414 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to determine whether community health workers (CHWs)-i.e., lay health workers with close ties to the communities they serve - can effectively teach cognitive-behavioral pain management strategies to older adults in a disadvantaged urban setting. Specific aims are: to test, in a sample of 414 primarily African American older adults, whether the STEPS pain self-management intervention, delivered over 7 weeks through telephone sessions with a CHW and mobile health tools, improves pain outcomes at 2 and 12 months compared to a usual care control group. We will also assess the mechanisms by which the intervention may bring about positive changes in pain outcomes. We will use mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and factors affecting implementation.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSTEPSParticipants will initially meet with a community health worker (CHW) for a 1-hour orientation at the participant's home, a Henry Ford Health System site or the University of Michigan Detroit Center, or virtual. The CHW will show participants how to use the web modules. Participants will be given (or mailed) a wearable activity tracker to use throughout the course of the 7-week program. Each week participants will watch a brief video on the STEPS website; they may also be asked to complete handouts in the workbook. They will have a weekly 30-minute telephone session with the CHW. CHWs will review the weekly topic, help participants practice new skills, and set a related goal. CHWs will screen for social needs and make appropriate community referrals. Participants will set walking goals each week, using step-count data from the physical activity tracker. Participants will track daily step counts.

Timeline

Start date
2022-11-29
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2022-03-14
Last updated
2025-11-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05278234. Inclusion in this directory is not an endorsement.