Status:
COMPLETED
RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
Lead Sponsor:
University of Michigan
Conditions:
Scleroderma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
The study is supported by Dan Barry Trainee Research Program through the Department of Physical Medicine and Rehabilitation at Michigan Medicine.
Eligibility Criteria
Inclusion
- Participants from our previous clinical trial, who received the original RENEW intervention (n=66), will be invited to participate in this study.
- Participants who have a medical diagnosis of systemic sclerosis, any subtype (diffuse, limited, Sine, or overlap)
- Participants who report a mean score 4 or more on the Fatigue Severity Scale, indicative of problematic fatigue; potential mean range 1-9
- Participants who have access to a computer and an internet connection
- Participants who are able to speak and read English.
Exclusion
- Individuals who did not participate in the original RENEW trial
- Individuals who lack access to reliable high-speed internet will be excluded to ensure they can fully engage with the AI-supported health coaching and digital components of the study
- Non-English speakers will be excluded because the current version of the AI tool is available only in English
- Individuals planning to initiate any new treatments specifically targeting fatigue, pain, or mood symptoms (such as psychological therapy, structured rehabilitation, or new medications) during the 4-week study period will be excluded, to avoid confounding effects on the study outcomes.
- Individuals with other significant medical or logistical issues that would impede meaningful participation, such as severe concurrent medical conditions, inability to access the RENEW intervention, or cognitive impairments that prevent them from engaging with study procedures, will also be excluded.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06999226
Start Date
May 19 2025
End Date
August 1 2025
Last Update
August 20 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109