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Completed

NCT Number: NCT05278234

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STEPS

Behavioral

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.

Other names: Seniors using Technology to Engage in Pain Self-management

Primary outcomes

  1. Change in Pain Interference

    Time frame: 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 outcomes

  1. Participant Global Impression of Change--Pain

    Time frame: 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.

  2. Participant Global Impression of Change - Functioning

    Time frame: 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.

  3. Change in pain intensity

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Henry Ford Health System
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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