RecruitingNot ApplicableNCT07403669

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment

Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial

Sponsor

Aventyn, Inc.

Enrollment

300 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Diabetes Mellitus Kidney Disease Acute MI

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is assessing how well patients with heart, kidney, and metabolic conditions (a combination called CKM syndrome) understand and manage their own health. The goal is to improve patient education and empowerment through regular check-ins and health assessments. **You may be eligible if...** - You are 18 years or older - You have at least one of the following: - Diabetes with an HbA1c (blood sugar average) of 7.5% or higher - Heart disease with a stent placed in a coronary artery - Heart bypass surgery (CABG) in the last 12 months - Chronic kidney disease (stage 2–4) - If you have heart failure, you must have been hospitalized within the past week **You may NOT be eligible if...** - You are unwilling to sign an informed consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCHAPERONE 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

DEVICECKMiq 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.

OTHERQuality 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