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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women over 18 years of age are included

• 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;

• or Chronic Kidney Disease (CKD) stage 2- 4

• and, in those with Heart failure, a recent hospitalization within one week of enrollment is required

Locations
United States
Arizona
Fountains Family Care
COMPLETED
Chandler
Gilbert Cardiology
RECRUITING
Gilbert
Arizona Heart Foundation
RECRUITING
Phoenix
East Valley Diabetes
COMPLETED
San Tan Valley
Other Locations
Sweden
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Navin Govind Steering Committtee, MS
info@aventyn.com
2317942328
Backup
Aditya Vijay, MS
2317942328
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2027-04-22
Participants
Target number of participants: 300
Treatments
Placebo_comparator: Intervention
All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm
No_intervention: Control
All qualified cardio kidney metabolic patients including CHF subjects in control arm
Sponsors
Collaborators: Arizona State University, Intel Corporation, University of Arizona, Karolinska University Hospital, Creighton School of Medicine, Phoenix Arizona, University of Phoenix College of Nursing, Arizona Heart Foundation, Partnership for Economic Innovation Arizona, Dignity Health, Kanasu Labs
Leads: Aventyn, Inc.

This content was sourced from clinicaltrials.gov