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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an AI health coaching tool, RENEW-AI, designed to help individuals with systemic sclerosis (a chronic connective tissue disease) manage their condition more effectively. Over four weeks, the AI provides education, goal-setting advice, and emotional support. The study aims to assess the tool's ease of use and usefulness for participants. It targets individuals who participated in a previous trial, have systemic sclerosis, experience significant fatigue, and have internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance disease management for many.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot start any new treatments for fatigue, pain, or mood symptoms during the study.

What prior data suggests that this AI health coaching tool is safe for individuals with Systemic Sclerosis?

Research shows that the RENEW-AI treatment, which uses an AI health coach, helps people with scleroderma set health goals, learn about their condition, and receive emotional support. Studies have mainly focused on the tool's ease of use and acceptability over a short period.

Since RENEW-AI is neither a drug nor an invasive treatment, it lacks the typical side effects associated with medications. Instead, the study evaluates how effectively people can use and benefit from the AI tool. No evidence of physical harm exists, as it's a digital assistant meant to provide support and education.

For those considering joining a trial with RENEW-AI, the goal is to enhance the experience of managing scleroderma through digital support, which is generally considered safe. Previous studies have not shown any safety issues, as the AI is designed to support rather than physically treat. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for scleroderma, which often involve medications to manage symptoms and immune system activity, the RENEW-AI app features a unique AI-driven chat functionality. This chat, powered by a large language model and fine-tuned with prompt engineering, offers personalized support and guidance to participants. Researchers are excited because this innovative approach could provide tailored, real-time assistance, potentially improving the quality of life for those with scleroderma by addressing individual needs in a dynamic way.

What evidence suggests that the AI Health Coach is effective for Scleroderma?

Research has shown that an AI health coach can help people manage Systemic Sclerosis (SSc), also known as scleroderma. In this trial, participants will use the RENEW-AI Chat, an AI tool designed to educate and assist in setting or adjusting personal health goals, which is crucial for those with this condition. Studies have found that combining technology with health coaching can improve how well people with SSc manage their health. This approach aims to empower individuals by helping them understand the disease better and manage their symptoms more effectively. While the main goal is to assess the tool's practicality, the AI health coach is expected to assist in handling the challenges of scleroderma. ^{1 2 3 5 6}

Who Is on the Research Team?

Nirali Shah

Principal Investigator

University of Michigan

Susan Murphy

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06999226

RENEW-AI: Personalizing Scleroderma Management With ... 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.

2. trials.arthritis.org trials.arthritis.org/trials/NCT06999226

RENEW-AI: Personalizing Scleroderma Management With an AI ... 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 ...

3. academic.oup.com academic.oup.com/rheumap/article/8/2/rkae040/7624628

Impact of a resilience-building energy management ... Incorporating peer health coaches and technology is beneficial for self-management interventions for people with SSc. Future tailoring of RENEW based on SSc ...

4. withpower.com withpower.com/trial/phase-scleroderma-systemic-4-2025-547b6

AI Health Coach for Scleroderma · Info for Participants ... RENEW-AI will have tolerable side effects & efficacy for patients with Systemic Sclerosis, Systemic Sclerosis and Scleroderma. Learn more about the study.

5. researchprotocols.org researchprotocols.org/2020/4/e16799/

The Scleroderma Patient-Centered Intervention Network ... Conclusions: The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc.

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0013449

Scleroderma (DBCOND0013449) Phase, Status. NCT06999226. RENEW-AI: Personalizing Scleroderma Management With an AI Health Coach, No drug interventions, supportive_care, Not Available ...