300 Participants Needed

Health AI for Kidney Disease

(CHAPERONE-CKM Trial)

Recruiting at 2 trial locations
NG
Overseen ByNavin Govind Steering Committtee, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Aventyn, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new Health AI tool, CHAPERONE AI, can manage kidney disease using smart technology like chatbots and sensors. The goal is to determine if these tools can ease living with kidney-related issues and improve long-term health outcomes. Participants will either use the AI tool or be in a control group to compare results. The trial seeks individuals with diabetes and high blood sugar, heart disease with recent stent placement, recent coronary surgery, or moderate chronic kidney disease. Those with heart failure must have been hospitalized within a week before joining the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance kidney disease management for many.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Health AI solution is safe for kidney disease patients?

Research shows that the CHAPERONE AI is under careful monitoring to assess its effectiveness and safety. The goal is to determine if it can manage kidney disease without causing significant issues for patients. Other studies have generally found similar health AI tools to be well-tolerated, with most users not experiencing severe side effects.

Treatments that reach advanced research stages typically demonstrate some safety in early tests. Since this trial involves a health AI, potential side effects may relate more to user interaction than physical effects. So far, there has been little information about serious problems related to CHAPERONE AI, which is encouraging.

Overall, while more data is needed, existing studies suggest that CHAPERONE AI might be safe for managing kidney disease.12345

Why are researchers excited about this trial?

Researchers are excited about CHAPERONE AI for kidney disease because it leverages advanced artificial intelligence to personalize treatment plans for patients with cardio kidney metabolic issues, including those with congestive heart failure. Unlike traditional treatments, which often follow a one-size-fits-all approach, CHAPERONE AI analyzes individual patient data to optimize care. This could lead to more effective management of kidney disease by precisely targeting each patient’s specific needs, potentially improving outcomes and reducing side effects.

What evidence suggests that the CHAPERONE AI is effective for reducing CKM disease burden?

Research has shown that Health AI tools like CHAPERONE, which participants in this trial may receive, can significantly aid in managing kidney disease. Studies indicate that AI tools, such as chatbots and devices monitoring vital signs, reduce risks and improve kidney health. AI helps by predicting the progression of kidney disease and creating personalized treatment plans for each person. Other research has found that AI decreases the risk of poor kidney outcomes, especially when used for tailored care. These findings suggest that AI could be a promising way to manage and lessen the impact of kidney disease.12678

Who Is on the Research Team?

KV

Kris Vijay Study Chair, MD

Principal Investigator

Aventyn, Inc.

ZL

Zaki Lababidi PI, MD

Principal Investigator

Gilbert Cardiology

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diabetes (A1C ≥ 7.5), heart disease post-stent or CABG within the last year, or CKD stages 2-4. Heart failure patients must have been hospitalized within a week of enrollment.

Inclusion Criteria

I am over 18 years old.
My A1C level is 7.5 or higher.
I have heart disease and have had a stent placed.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with Health AI Chatbot, Copilot, LLM, and vital sign monitoring device to reduce CKM disease burden

24 weeks
Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on reduction of kidney failure, heart failure, and diabetes complications

26 weeks
3 visits (virtual) at 30, 90, and 180 days

Extension

Optional long-term monitoring and engagement with AI tools for continued health assessment

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • CHAPERONE AI

Trial Overview

The CHAPERONE solution uses Health AI Chatbot, Copilot, LLM, and vital sign monitors to manage cardiovascular, kidney, and metabolic health. It aims to reduce disease burden through technology tools and patient empowerment.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: ControlActive Control1 Intervention
Group II: InterventionPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aventyn, Inc.

Lead Sponsor

Trials
5
Recruited
28,100+

Karolinska University Hospital

Collaborator

Trials
509
Recruited
1,319,000+

Partnership for Economic Innovation Arizona

Collaborator

Kanasu Labs

Collaborator

Intel Corporation

Industry Sponsor

Trials
10
Recruited
28,800+

Dignity Health

Collaborator

Trials
3
Recruited
350+

Arizona Heart Foundation

Collaborator

Arizona State University

Collaborator

Trials
311
Recruited
109,000+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

University of Phoenix College of Nursing

Collaborator

Citations

Cardiovascular Kidney and Metabolic Health Assessment ...

The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health AI ...

Health AI for Kidney Disease (CHAPERONE-CKM Trial)

The CHAPERONE solution uses Health AI Chatbot, Copilot, LLM, and vital sign monitors to manage cardiovascular, kidney, and metabolic health. It aims to reduce ...

Kidney care: the economics of innovation

“The future of kidney care includes a personalised approach to reducing risk factors and addressing the individual concerns of each patient,” ...

Improving Kidney Outcomes in Patients With Nondiabetic ...

The utilization of the KidneyOnline intelligent care system was associated with reduced risk of unfavorable kidney outcomes in nondiabetic ...

Artificial Intelligence for Chronic Kidney Disease Early ...

This research explores the transformative role of AI, particularly machine learning (ML) and deep learning (DL), in predicting CKD progression and facilitating ...

Cardiovascular Kidney and Metabolic Health Assessment and ...

The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy ...

Using the American heart association's new 'cardiovascular ...

Obesity, diabetes mellitus, and chronic kidney disease (CKD) are strongly associated with cardiovascular disease (CVD) and all-cause mortality [ ...

Study Identifies Prevalence of Cardio-Renal-Metabolic ...

More than 1 in 4 adults have 1 or more conditions that fall into the cardio-renal-metabolic category, according to findings released during ...