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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG071511 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Henry Ford Health System | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Participants will engage in a 7-week multicomponent chronic pain self-management program. |
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| Usual care control arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Participant Global Impression of Change - Functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40457457 | Derived | Janevic MR, Lindsay R, Brines E, Wisdom K, Robinson-Lane SG, Brewer R, Murphy SL, Piette J, Grijalva L, Anderson M, Clement J, Latimer C. A community health worker-delivered intervention (STEPS) to support chronic pain self-management among older adults in an underserved urban community: protocol for a randomized trial. Trials. 2025 Jun 2;26(1):186. doi: 10.1186/s13063-025-08892-w. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2024 | Nov 6, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2024 | Nov 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| 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 |