A New Model to Reach Vulnerable Older Adults With Pain Self-management Support

Study Overview
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Brief Summary
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Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.

Official Title
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A New Model to Reach Vulnerable Older Adults With Pain Self-management Support

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: STEPS (Seniors using Technology to Engage in Pain Self-management)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-proficient Age >= 60 years Ambulatory with or without assistive device Community-living Have a cell or landline phone Have Internet access (home or elsewhere) 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 Ability to attend a one-time study orientation session Exclusion Criteria: Serious acute illness or hospitalization in last month Planned surgery in next three months Significant cognitive impairment as indicated by affirmative response to question: Do you have significant difficulties with your memory that get in the way of your usual daily activities? Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will engage in a 7-week chronic pain self-management program. | Behavioral: STEPS (Seniors using Technology to Engage in Pain Self-management)<br>* Participants will meet with a community health worker (CHW) at a one-hour in-person study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and associated materials, and schedule six weekly telephone sessions with the CHW. Participants will be given a wearable physical activity tracker to use throughout the course of the program. They can choose to report daily step counts by automatically syncing to an app or via text message. Each week during the study period, participants will engage with content on the website, have a session with the community health worker, track their daily steps, and set and work toward pain-management goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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).. | baseline and 8 weeks | 
| Participant engagement | Number of completed sessions with the community health worker (range 1 to 7). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Global Impression of Change | Two items: 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)). | 8 weeks | 
| Participant satisfaction: Likert-scale questions | Likert-scale questions about participant satisfaction with the program; e.g., whether participation increased understanding of pain management (Strongly Agree=1 to Strongly Disagree=5), and with selected program elements (e.g., community health workers, videos, website). | 8 weeks |