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RECRUITING
NCT07403669
NA

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment

Sponsor: Aventyn, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-10-22

Completion Date

2027-04-22

Last Updated

2026-02-12

Healthy Volunteers

No

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

Locations (5)

Fountains Family Care

Chandler, Arizona, United States

Gilbert Cardiology

Gilbert, Arizona, United States

Arizona Heart Foundation

Phoenix, Arizona, United States

East Valley Diabetes

San Tan Valley, Arizona, United States

Karolinska University Hospital

Stockholm, Sweden