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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01341-48 | Registry Identifier | IDRB |
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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
| University Hospital, Toulouse | OTHER |
| University Hospital, Tours | OTHER |
| Biogroup Laboratoire de biologie médicale |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | No Intervention | Participants will get as in the routine care, no message will be disseminated for this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| 2 years after randomization and dissemination of health-related messages |
| Measure | Description | Time Frame |
|---|---|---|
| Specific health outcomes | Change in specific health outcomes (separately analysed):
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Main inclusion criteria:
Main exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samy Hadjadj, PU-PH | Contact | +33244768545 | +33244768545 | samy.hadjadj@univ-nantes.fr |
| Sonia Brinet | Contact | +33253526126 | sonia.brinet@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Samy Hadjadj, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biogroup laboratories | Nantes | 44000 | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| UNKNOWN |
| Santé publique France-InVS (Institut National de Veille sanitaire) | UNKNOWN |
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.
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| 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 | 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 | 2 years before and after randomization and dissemination of health-related messages |
| Impact on medical costs | Changes between groups:
| 2 years after randomization and dissemination of health-related messages |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |