Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- 否
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
All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm
干预措施: CHAPERONE AI (Other)
Intervention
All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm
干预措施: CKMiq AI (Device)
Intervention
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
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.)
