Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- University of Michigan
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change in pain interference
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Mary Janevic
Research Associate Professor
University of Michigan
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in subjective cognitive functioning(Baseline, 10 weeks from baseline)
- Change in pain intensity(Baseline, 10 weeks from baseline)