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

Chronic Pain Clinical Trial

Official title:

An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-Management Support for Vulnerable Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278234
• Other study ID #: HUM00206235
• Secondary ID: 1R01AG071511
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: April 2026

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: Mary Janevic
• Phone: 7346473194
• Email: mjanevic[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• STEPS
Participants will initially meet with a community health worker (CHW) for a 1-hour orientation at the participant's home, a Henry Ford Health System site or the University of Michigan Detroit Center, or virtual. The CHW will show participants how to use the web modules. Participants will be given (or mailed) a wearable activity tracker to use throughout the course of the 7-week program. Each week participants will watch a brief video on the STEPS website; they may also be asked to complete handouts in the workbook. They will have a weekly 30-minute telephone session with the CHW. CHWs will review the weekly topic, help participants practice new skills, and set a related goal. CHWs will screen for social needs and make appropriate community referrals. Participants will set walking goals each week, using step-count data from the physical activity tracker. Participants will track daily step counts.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Henry Ford Health System, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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