Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events

N/ANot Yet RecruitingNCT07634718

Nantes University Hospital125,000 enrolled

Overview

The goal of this clinical study is to establish if the use of public health-related messages, designed and disseminated to a targeted population, will result in tangible improvements in patient outcomes and healthcare practices. Specific health-related messages oriented towards patients, through their biological results and HealthCare Professionals (HCPs), will be sent to participants included in the intervention group. The control group will not receive any health-related message (routine care). The aim is to evaluate if this intervention leads to differences in Major Adverse Renal and Cardiovascular Events (MARCE), compared to routine care (no dissemination of health messages) in patients suffering in diabetes and renal failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

125,000

Conditions

Diabetes Renal Failure , Chronic

Interventions

Patient will be included in the intervention according to the laboratory's randomization arm.The intervention consists in delivering patient information messages in laboratory reports, providing access to an educational video for patients and a specific message for the prescribing physician in the intervention arm, without modifying patient care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Main inclusion criteria: * Subject attending a ML participating to the study * Subject presenting a HbA1c ≥ 6.5% and an estimated GFR (CKD-EPI formula) in the range 60 to 15 ml/min (included) and/or albumin to creatinine ratio ≥ 300 mg albumin/g creatinine (or 30 mg/mmol creatinine), on the same biological determination. Main exclusion criteria: * Subject previously identified as opposed to the use of their medical data and/or access of their SNDS data, * Subject not registered to the French social security system, * Subject with estimated GFR \< 15 ml/min on the day of inclusion

Outcomes

Primary Outcomes

Major Adverse Renal and Cardiovascular Events (MARCE) occurrence

Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring): * All-cause death * Myocardial infarction (universal definition) * Stroke (universal definition) * Sustained (over 45 days) use of renal replacement therapy * Heart failure leading to hospitalization (definition by the European Society of Cardiology)

Time frame: 2 years after randomization and dissemination of health-related messages

Secondary Outcomes

Specific health outcomes

Change in specific health outcomes (separately analysed): * All-cause death * Myocardial infarction * Stroke * Sustained (over 1 month) use of renal replacement therapy * Heart failure leading to hospitalization * Lower limb amputation, with special information on the site of amputation (toe, transmetatarsal, transtibial, transfemoral) * Arterial revascularization in the coronary, cerebrovascular and/or lower aorta/lower limb territories * Severe diabetic retinopathy (laser procedure, eye surgery for diabetes complication and intravitreal injection associated with specific drug delivery and/or their combinations

Time frame: 2 years after the randomization and dissemination of health-related messages

Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology

Change in Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology

Time frame: 6 months and 2 years after randomization and dissemination of health-related messages

Biological characteristics

Changes in biological results of: lipids, liver and renal functions, blood cell count, HbA1c, CRP , Blood chemistry and Blood and urine urea

Time frame: 2 years before and after randomization and dissemination of health-related messages

Impact on medical costs

Changes between groups: * in euros of patients healthcare costs, * in type of costs (consultation, hospitalisation, etc), * in euros of the intervention impact, * in QALY of cost-effectiveness