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The purpose of this pilot study is to explore the use of a large language model (LLM) in providing education and behavioral health coaching for individuals with Systemic Sclerosis (SSc). The goal of the LLM is to help user set or modify behavioral goals, provide education, or emotional support as needed by the participant. The primary outcome for this study is to assess the feasibility and acceptability of using an AI-supported health coaching tool over a four-week period.
The study is supported by Dan Barry Trainee Research Program through the Department of Physical Medicine and Rehabilitation at Michigan Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RENEW-AI Chat arm | Experimental | Participants (n=20) who participated in the original RENEW trial will get access to a chat functionality within the RENEW app. The chat functionality in the RENEW app is powered by a large language model and tailored using prompt engineering techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENEW-AI | Behavioral | AI assisted health coaching using the LLM-driven chat functionality. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engagement with the AI chat feature | Engagement is measured through app analytics (It will be reported as the proportion of participants who use the chat feature.) | Up to 4 weeks |
| Satisfaction with AI-generated health coaching | Satisfaction is self-reported on the mhealth satisfaction survey v 1. It is a 14-item survey with Likert like questions ranging from 1, strongly disagree to 5, strongly agree. Higher scores imply more satisfaction | 4 weeks |
| Acceptability of RENEW | Assessed via focus groups | 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue | Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue short form (FACIT-F) is a 13 item subscale that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varies from 0-52 with a lower score indicating a more severe fatigue level. | Baseline, week 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirali Shah | University of Michigan | Principal Investigator |
| Susan Murphy | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
IPD can be shared upon requests to the PI. Requests will be considered on an individual basis.
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Phase 2 will involve a single-arm, pre-post study design where 20 participants of the original RENEW trial will use the NLP-chat feature integrated into the RENEW app over a 4-week period.
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The study team members who interact with participants during the enrollment process will be blinded to participant feedback provided during the study to avoid any influence on the participants' experience or outcomes.
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| Change in Pain interference | Assessed using the PROMIS Pain Interference short form - 4 item Likert like questions ranging from 1, not at all to 5, very much. Higher scores imply more pain interference | Baseline, week 4 |
| Change in Depressive symptoms | Assessed using the PROMIS Depression short form - 4 item Likert like questions ranging from 1, never to 5, always Higher scores imply more depression | Baseline, week 4 |
| Change in Resilience | Assessed using the Connor-Davidson Resilience Scale - 10 item Likert like questions ranging from 0, not true at all to 4, true nearly all the time Higher scores imply more resilience | Baseline, week 4 |