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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Health-related messages

Treatment groups

125,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nantes University Hospital

Lead sponsor

Hospices Civils de Lyon

Collaborator

University Hospital, Toulouse

Collaborator

University Hospital, Tours

Collaborator

Biogroup Laboratoire de biologie médicale

Collaborator

Santé publique France-InVS (Institut National de Veille sanitaire)

Collaborator