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临床试验/NCT07403669
NCT07403669招募中不适用

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

Aventyn, Inc.5 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2025年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Aventyn, Inc.
入组人数
300
试验地点
5
主要终点
CHAPERONE AI Treatment

研究概览

简要总结

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.

详细描述

The interconnectedness between Diabetes, Heart disease and Kidney disease (Cardio Kidney Metabolic) has never been more important to recognize than the present day as the current data on the prevalence of this trifecta suggests an exponential increase in comorbidity, death, poor quality of life and a colossal economic burden on the society. Risk factors such as hypertension, high cholesterol, smoking, prediabetes states, obesity, unhealthy eating habits, lack of exercise, micro particle air pollution, high inflammatory markers, life stressors and genetics play a significant role in triggering the onset of these diseases and their complications. Half a Billion people in the world are expected to be having diabetes by 2023; another 150 million with prediabetes and one billion with hypertension ( Already 130Million in the US have Hypertension now )

Problem of Kidney Disease:

More than 37 million Americans have kidney disease and millions more are at risk. According to the Centers for Disease Control and Prevention (CDC), 9 out of 10 people with early kidney disease don't know they have it because it usually has no symptoms until the late stages. Simple blood and urine tests can tell how well the kidneys are working. Diabetes and high blood pressure are the two leading causes of kidney disease. Kidney disease can lead to heart attack, stroke, kidney failure and death. With recent advances in research, Kidney disease can be treated if caught and treated early and it is often possible to slow or stop the progress of kidney disease with diet, exercise, lifestyle modifications and a few newer medications. Besides diabetes and high blood pressure, other common risks for kidney disease include having a family history of kidney disease, Black heritage, Hispanic, Asian American, or Native American. Black Americans are 3.4 times more likely than whites to develop kidney failure if over 60 years of age, and Hispanics are 1.5 times more likely than non- Hispanics to develop kidney failure. There are more than 785,000 people with kidney failure in the United States-an increase of more than 100% since 2000.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Those subjects who are not willing to sign an informed consent

研究组 & 干预措施

Intervention

Placebo Comparator

All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm

干预措施: CHAPERONE AI (Other)

Intervention

Placebo Comparator

All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm

干预措施: CKMiq AI (Device)

Intervention

Placebo Comparator

All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm

干预措施: Quality of Life (Other)

Control

No Intervention

All qualified cardio kidney metabolic patients including CHF subjects in control arm

结局指标

主要结局

CHAPERONE AI Treatment

时间窗: 30 days, 90 days and 180 days in patients CKM

Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, Acute Mi events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in patients CKM

次要结局

  • CHAPERONE AI Reduced Readmissions(30, 90 and 180 days.)

研究者

发起方
Aventyn, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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