Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial (STEPS-CI)

University of Michigan

Status: Completed

Conditions: Cognitive Impairment; Chronic Pain

Treatments: Behavioral: STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06182423

HUM00237064

R01AG071511-02S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

STEPS-CI Intervention Group

Experimental group

Description:

Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.

Treatment:

Behavioral: STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)

STEPS-CI Control Group

No Intervention group

Description:

Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.