RecruitingNot applicable

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 60 years
  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Simple blood and urine tests can tell how well the kidneys are working."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether AI tools, remote health monitors, and support for patients can reduce problems from heart, kidney, and blood sugar diseases. It is for adults over 18 who have at least one of the listed health conditions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be over 18 years old.
  • Have at least one of these: diabetes with an A1C of 7.5 or higher (a measure of average blood sugar); heart disease treated with a stent (a small tube that keeps a blood vessel open); heart bypass surgery in the past 12 months; or long-term kidney disease at stage 2, 3, or 4.
  • If you have heart failure (the heart does not pump well), you must have been hospitalized within one week before joining.

Who can't join

  • Not willing to sign a form agreeing to join the study after learning about it.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Those subjects who are not willing to sign an informed consent

Study sites (4)

AZ