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

Обзор

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.

Вмешательства

• Другое Health-related messages
  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.

Первичные конечные точки

• Major Adverse Renal and Cardiovascular Events (MARCE) occurrence [Срок оценки: 2 years after randomization and dissemination of health-related messages]

Вторичные конечные точки (4)

• Specific health outcomes [Срок оценки: 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 [Срок оценки: 6 months and 2 years after randomization and dissemination of health-related messages]
• Biological characteristics [Срок оценки: 2 years before and after randomization and dissemination of health-related messages]
• Impact on medical costs [Срок оценки: 2 years after randomization and dissemination of health-related messages]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Biogroup laboratories — Nantes

Идентификаторы

NCT: NCT07634718 · RC25_0253 · 2025-A01341-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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