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

NCT07634718 | Not Yet Recruiting

• 2 other identifiers: RC25_02532025-A01341-48
• Study Type: interventional
• Target: 125,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Renal Failure , Chronic

Keywords

implementation; heatlh-related message; Renal and cardiovascular event

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years after randomization and dissemination of health-related messages

Secondary Outcomes (4)

• Specific health outcomes

  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

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

• Biological characteristics

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

• Impact on medical costs

  2 years after randomization and dissemination of health-related messages

Study Arms (2)

health-related arm

EXPERIMENTAL

Participants will receive an health-related message included in the biological results form. A short graphical illustration will indicate the patient-risk level according the biological results and video detailing national recommendations. HCPs will receive a SIGNAL BIO message which was elaborated on evidence-based treatments and/or strategy for patients with diabetes.

Other: Health-related messages

Control group

NO INTERVENTION

Participants will get as in the routine care, no message will be disseminated for this group.

Interventions

Health-related messages OTHER

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.

health-related arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Nantes University Hospital: lead
• 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

Study Sites (1)

Biogroup laboratories

Nantes, 44000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samy Hadjadj, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samy Hadjadj, PU-PH

CONTACT

+33244768545; samy.hadjadj@univ-nantes.fr

Sonia Brinet

CONTACT

+33253526126; sonia.brinet@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ITINERANCE is a controlled, multicentric, randomized cluster trial in two parallel arms. Randomization units will be Medical Laboratories (ML) sites. All ML sites will be randomized concomitantly.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)