AI Health Coach for Scleroderma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: No internet, Non-English, New treatments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nirali Shah

Principal Investigator

University of Michigan

Susan Murphy

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with Systemic Sclerosis (SSc), also known as scleroderma. It's designed to see if an AI Health Coach, called RENEW-AI, can help them set health goals, learn about their condition, and offer emotional support over four weeks.

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 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

I speak and understand English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the AI-supported health coaching tool to set or modify behavioral goals, receive education, and emotional support

4 weeks

Virtual interactions via app

Follow-up

Participants are monitored for changes in fatigue, resilience, pain interference, and depressive symptoms

4 weeks

Treatment Details

Interventions

• RENEW-AI

Trial Overview RENEW-AI is being tested in this pilot study. Participants will interact with a large language model AI that acts as a health coach. The study aims to determine how feasible and acceptable it is for patients to use this tool.

Participant Groups

Group I: RENEW-AI Chat arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+