An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-Management Support for Vulnerable Older Adults
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- University of Michigan
- Enrollment
- 414
- Locations
- 1
- Primary Endpoint
- Change in Pain Interference
- Status
- Active, Not Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Mary Janevic
Associate Research Scientist
University of Michigan
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Participant Global Impression of Change - Functioning(2 months from baseline, and 12 months from baseline)
- Participant Global Impression of Change--Pain(2 months from baseline, and 12 months from baseline)
- Change in pain intensity(Baseline, 2 months from baseline, and 12 months from baseline)