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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG022845 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Northern Michigan Health Consortium | UNKNOWN |
| Weill Medical College of Cornell University | OTHER |
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The goal of this clinical trial is to test a new community health worker-delivered program (Strengthening COnnections to Overcome Pain, or SCOOP) that teaches strategies for managing chronic pain and loneliness to older adults living in rural areas. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCOOP Intervention Group | Experimental | SCOOP is a 7-week intervention, delivered primarily over the telephone by community health workers, to support chronic pain self-management and social connectedness. |
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| Control group | No Intervention | Control group participants receive usual care between the baseline and 8-week follow-up survey. After completing the follow-up survey, control participants will be invited to take part in an educational workshop about pain and loneliness and will receive all intervention materials. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strengthening COnnections to Overcome Pain (SCOOP) | Behavioral | Each week for 7 weeks, SCOOP intervention group participants will watch a brief video on the study website teaching a pain management or social connectedness skill and have a session with a community health worker, where they will receive support with behavioral goal-setting related to pain management and/or social connections. Participants will be screened for unmet social needs and connected to appropriate resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement as measured by number of sessions completed | Number of sessions out of 7 that participants have completed 8 weeks from baseline. | 8 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Participant satisfaction with the SCOOP intervention | Items ask about overall satisfaction with the program, i.e., whether participation increased understanding of pain management and increased knowledge of strategies to improve social connection (1= Strongly Disagree to 5= Strongly Agree). The mean of the two items will be calculated. A higher score indicates greater participant satisfaction with the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Impression of Change in Pain, Functioning, and Loneliness | Three items, analyzed separately: 1) How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). 2) How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)). 3) How participant thinks their feelings of loneliness have changed from baseline (much worse (-3) to much better(+3)). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary R. Janevic, PhD | Contact | 734-647-3194 | mjanevic@umich.edu | |
| Rebecca Lindsay, MPH | Contact | 734-763-6369 | reblin@umich.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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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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| 8 weeks from baseline |
| Change in Loneliness as measured by the UCLA 8-item Loneliness Scale | Eight items ask about feelings of loneliness and social isolation. Each question is rated on a 4-point scale: 1=never, 2=rarely, 3=sometimes, and 4 =always. Two positively worded items ("I am an outgoing person" and "I can find companionship when I want it" are reverse-scored. All items are summed to give a total score of 8 to 32 points. A higher score indicates a greater degree of loneliness. | Baseline, 8 weeks from baseline |
| Change in Pain Interference 6-item subscale from 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). Scores are converted to a standardized T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured. | Baseline, 8 weeks from baseline |
| 8 weeks from baseline |