Recruiting

CHAPERONE-CKMCKM Health Assessment and Patient Empowerment in Chronic Disease using Health Coach Intervention

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Study Aim

This study aims to improve your health outcomes by using a health coach intervention, focusing on reducing kidney failure, heart failure, acute heart events, diabetes complications, hospitalization, and all-cause mortality over 30, 90, and 180 days if you have Chronic Kidney Disease (CKD).

What is being tested

CHAPERONE AI

+ CKMiq AI

+ Quality of Life

OtherDevice
Who is being recruted

Urogenital Diseases+11

+ Cardiovascular Diseases

+ Diabetes Mellitus

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorAventyn, Inc.
Study ContactNavin Govind Steering Committtee, MSMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on the connection between diabetes, heart disease, and kidney disease, often referred to as Cardio Kidney Metabolic (CKM) diseases. These conditions are increasingly common, leading to poor quality of life, premature death, and significant economic burden. The study aims to improve the health of individuals with these chronic diseases using a unique Health Coach Intervention Model. This model is designed to address risk factors such as high blood pressure, high cholesterol, smoking, obesity, unhealthy eating, lack of exercise, and life stressors that contribute to the onset and progression of CKM diseases. The study involves the use of a health coach intervention, known as CHAPERONE AI Treatment. Participants will receive guidance and support to manage their health and reduce the risk of complications. The effectiveness of this treatment will be measured by tracking improvements in patient outcomes. These include the reduction of kidney failure or progression of kidney disease, heart failure, heart attacks, diabetes complications, hospitalizations, and overall mortality rate at 30, 90, and 180 days.

Official TitleCardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial
Principal SponsorAventyn, Inc.
Study ContactNavin Govind Steering Committtee, MSMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesCardiovascular DiseasesDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHeart DiseasesHeart FailureKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesGlucose Metabolism DisordersFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Eligible subjects must have one of the risk factor/ disease component of CKM

Diabetes with A1C of 7.5 or higher

or Heart disease with stent placement

or Coronary Artery Bypass Graft (CABG) in the last 12 months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

100% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Patients receive AI-based treatment using CHAPERONE AI and CKMiq AI. These tools aim to improve heart and kidney health, reduce hospitalizations, and enhance quality of life. No placebo is used in this group.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Gilbert Cardiology

Gilbert, United StatesOpen Gilbert Cardiology in Google Maps
Recruiting

Arizona Heart Foundation

Phoenix, United States
Completed

Fountains Family Care

Chandler, United States
Completed

East Valley Diabetes

San Tan Valley, United States
Recruiting
5 Study Centers
CHAPERONE-CKM | CKM Health Assessment and Patient Empowerment in Chronic Disease using Health Coach Intervention | PatLynk