NCT06999226Completed
RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach
Source: ClinicalTrials.gov · Last updated 20 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 22 May 2025
- Start date
- 19 May 2025
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- University of Michigan
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06999226
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 19 May 2025 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.