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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Cognitive Impairment
• Intervention / Treatment: Behavioral: STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary R. Janevic, PhD; Phone Number: 734 647 3194; Email: mjanevic@umich.edu
• Study Contact Backup: Name: Rebecca Lindsay, MPH; Phone Number: 734 763 6369; Email: reblin@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	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).	Baseline, 10 weeks from baseline
Change in subjective cognitive functioning	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.	Baseline, 10 weeks from baseline

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Neurocognitive Disorders; Cognition Disorders; Chronic Pain; Cognitive Dysfunction
• Other Study ID Numbers: HUM00237064; R01AG071511-02S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No