Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Health-related messages.
- Who it may be relevant to
- Registry conditions: Diabetes, Renal Failure , Chronic. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Other 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.
Primary outcome measures
- Major Adverse Renal and Cardiovascular Events (MARCE) occurrence [Time frame: 2 years after randomization and dissemination of health-related messages]
Secondary outcome measures (4)
- Specific health outcomes [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 [Time frame: 6 months and 2 years after randomization and dissemination of health-related messages]
- Biological characteristics [Time frame: 2 years before and after randomization and dissemination of health-related messages]
- Impact on medical costs [Time frame: 2 years after randomization and dissemination of health-related messages]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Biogroup laboratories — Nantes
Identifiers
NCT: NCT07634718 · RC25_0253 · 2025-A01341-48