RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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The study is supported by Dan Barry Trainee Research Program through the Department of Physical Medicine and Rehabilitation at Michigan Medicine.

Conditions

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Scleroderma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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RENEW-AI Chat arm

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.

Group Type EXPERIMENTAL

RENEW-AI

Intervention Type BEHAVIORAL

AI assisted health coaching using the LLM-driven chat functionality.

Interventions

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RENEW-AI

AI assisted health coaching using the LLM-driven chat functionality.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No