STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults
NCT ID: NCT05278234
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
414 participants
INTERVENTIONAL
2022-11-29
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention arm
Participants will engage in a 7-week multicomponent chronic pain self-management program.
STEPS
Participants 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.
Usual care control arm
After completing the 12 month telephone survey, control group participants will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a workshop that provides key intervention content and individualized goal-setting guidance.
No interventions assigned to this group
Interventions
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STEPS
Participants 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a cell or landline phone
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \>= 3 months); \>=4 (0-10 scale) average pain level over last week; \>=1 day/previous 30 when pain made it difficult to do usual activities.
* Able to converse comfortably in English
Exclusion Criteria
* Planned major surgery in 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 study team to pose significant barrier to participation
50 Years
ALL
No
Sponsors
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University of Michigan
OTHER
National Institute on Aging (NIA)
NIH
Henry Ford Health System
OTHER
Responsible Party
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Mary Janevic
Associate Research Scientist
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Janevic MR, Lindsay R, Brines E, Wisdom K, Robinson-Lane SG, Brewer R, Murphy SL, Piette J, Grijalva L, Anderson M, Clement J, Latimer C. A community health worker-delivered intervention (STEPS) to support chronic pain self-management among older adults in an underserved urban community: protocol for a randomized trial. Trials. 2025 Jun 2;26(1):186. doi: 10.1186/s13063-025-08892-w.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00206235
Identifier Type: -
Identifier Source: org_study_id