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

NCT ID: NCT06182423

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-06-11

Brief 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.

Conditions

Chronic Pain; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STEPS-CI Intervention Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.

STEPS-CI Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Janevic

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AG071511-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00237064

Identifier Type: -

Identifier Source: org_study_id