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

University of Michigan

Status: Active, not recruiting

Conditions: Chronic Pain

Treatments: Behavioral: STEPS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05278234

HUM00206235

1R01AG071511 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 414 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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414 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Participants will engage in a 7-week multicomponent chronic pain self-management program.

Treatment:

Behavioral: STEPS

Usual care control arm

No Intervention group

Description:

After completing the 12 month telephone survey, control group participants will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a workshop that provides key intervention content and individualized goal-setting guidance.