STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: STEPS

• Registration Number: NCT05278234
• Lead Sponsor: University of Michigan

Brief Summary

The goal of this study is to determine whether community health workers (CHWs)-i.e., lay health workers with close ties to the communities they serve - can effectively teach cognitive-behavioral pain management strategies to older adults in a disadvantaged urban setting. Specific aims are: to test, in a sample of 414 primarily African American older adults, whether the STEPS pain self-management intervention, delivered over 7 weeks through telephone sessions with a CHW and mobile health tools, improves pain outcomes at 2 and 12 months compared to a usual care control group. We will also assess the mechanisms by which the intervention may bring about positive changes in pain outcomes. We will use mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and factors affecting implementation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-11-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

• Community-living
• Have a cell or landline phone
• Self-reported chronic musculoskeletal pain (pain in muscles or joints for >= 3 months); >=4 (0-10 scale) average pain level over last week; >=1 day/previous 30 when pain made it difficult to do usual activities.
• 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 or hip replacement);
• Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	STEPS	Participants will engage in a 7-week multicomponent chronic pain self-management program.

Primary Outcome Measures

Name	Time	Method
Change in Pain Interference	Baseline, 2 months from baseline, and 12 months 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 worse outcome.

Secondary Outcome Measures

Name	Time	Method
Participant Global Impression of Change - Functioning	2 months from baseline, and 12 months from baseline	How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Participant Global Impression of Change--Pain	2 months from baseline, and 12 months from baseline	How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Change in pain intensity	Baseline, 2 months from baseline, and 12 months from baseline	A numeric rating scale ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States