Skip to main content
OpenTrials
Completed

NCT Number: NCT06182423

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Pain Interference

    Time frame: Baseline, 10 weeks from baseline

    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. Change score represents [follow-up score - baseline score].

Secondary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline, 10 weeks from baseline

    A numeric rating scale of pain in the last week ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome). Change score represents [follow-up score - baseline score].

  2. Change in Subjective Cognitive Functioning

    Time frame: Baseline, 10 weeks from baseline

    The 4-item PROMIS Cognitive Function-Abilities Short Form 4a V. 2.0 measures perceived cognitive functioning in the last 4 days (e.g., "My mind has been as sharp as usual") on a scale from 1=not at all to 5=very much. Scores are converted to a standardized T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means better cognitive functioning. Change score represents [follow-up score - baseline score].

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: STEPS-CI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.