N/A
N=57
Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
Chronic Pain · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT06182423 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
May 2026
Primary outcome: Primary: Change in Pain Interference — -0.9; 0.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version) (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Interference |
-0.9; 0.2 | — |
| SECONDARY Change in Pain Intensity |
-0.1; -0.2 | — |
| SECONDARY Change in Subjective Cognitive Functioning |
1.2; 1.9 | — |
Summary
The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.
Eligibility Criteria
Inclusion Criteria
- Age > 50 years;
- Have a cell or landline phone and internet access;
- Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >1 day/previous 30 when pain made it difficult to do usual activities.
- Self-reported mild cognitive impairment (MCI)/memory difficulties that at least sometimes interfere with usual daily activities
- Willingness to meet by phone or video with a community health worker to learn potentially new ways to manage pain and commit to the duration of the program
- Able to converse comfortably in English.
Exclusion Criteria
- Serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement)
- Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder).
- Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.
Data sourced from ClinicalTrials.gov (NCT06182423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.