Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment

Summary

The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health Artificial Intelligence (AI) Chatbot, Copilot, Large Language Model (LLM) and vital sign monitoring device in reducing CKM disease burden using an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment.

Conditions

• Acute MI
• Heart Failure
• Diabetes Mellitus
• Kidney Disease

Interventions

OTHER

CHAPERONE AI

The primary objective of this study is to evaluate the efficacy of treatment strategy on the impact of an intervention that is AI, Machine Learning (ML) based using Chatbot and Copilot with algorithm based intervention in CKM subjects in reducing progression of CKM diseases. This will be based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, acute myocardial infarction (AMI) events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in CKM patients

DEVICE

CKMiq AI

To evaluate the effect of treatment in: reducing readmission's from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from info graphic resources provided by American Heart Association. Improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization. Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and cardiovascular mortality from hospitalization through 30, 90 and 180 days. New York Heart Association (NYHA) Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) will be captured.

OTHER

Quality of Life

Secondary and tertiary objectives of this study are to evaluate the effect of CHAPERONE intervention in: Improving LIFE ESSENTIAL-8 Score and Health Related Quality of Life (HRQOL) measured with the 12-item Short Form (SF-12) survey, which reflects general health status and leads to 2 scores

Sponsors & Collaborators

• Dignity Health

  collaborator OTHER

• Arizona Heart Foundation

  collaborator UNKNOWN

• Arizona State University

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• University of Phoenix College of Nursing

  collaborator UNKNOWN

• Creighton School of Medicine, Phoenix Arizona

  collaborator UNKNOWN

• Karolinska University Hospital

  collaborator OTHER

• Partnership for Economic Innovation Arizona

  collaborator UNKNOWN

• Kanasu Labs

  collaborator UNKNOWN

• Intel Corporation

  collaborator INDUSTRY

• Aventyn, Inc.

  lead INDUSTRY

Principal Investigators

• Kris Vijay Study Chair, MD · Aventyn, Inc.

• Zaki Lababidi PI, MD · Gilbert Cardiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-22

Primary Completion

2026-10-22

Completion

2027-04-22

FDA Device

Yes

Countries

• United States
• Sweden

Study Locations