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

NCT06182423 | Completed

• 2 other identifiers: HUM00237064R01AG071511-02S1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in pain interference

  The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing a worse outcome.

  Baseline, 10 weeks from baseline

Secondary Outcomes (2)

• Change in pain intensity

  Baseline, 10 weeks from baseline

• Change in subjective cognitive functioning

  Baseline, 10 weeks from baseline

Study Arms (2)

STEPS-CI Intervention Group

EXPERIMENTAL

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.

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

STEPS-CI Control Group

NO INTERVENTION

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.

Interventions

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain; Cognitive Dysfunction

Interventions

Palliative Care; Educational Status

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: June 25, 2024
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)