Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events (ITINERANCE)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Samy Hadjadj, PU-PH
- 전화번호: +33244768545 +33244768545
- 이메일: samy.hadjadj@univ-nantes.fr
연구 연락처 백업
- 이름: Sonia Brinet
- 전화번호: +33253526126
- 이메일: sonia.brinet@chu-nantes.fr
연구 장소
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Nantes, 프랑스, 44000
- Biogroup laboratories
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연락하다:
- Claire Vignault, MD
- 전화번호: 0645644018
- 이메일: claire.vignault@biogroup.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: health-related arm
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. |
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.
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간섭 없음: Control group
Participants will get as in the routine care, no message will be disseminated for this group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Major Adverse Renal and Cardiovascular Events (MARCE) occurrence
기간: 2 years after randomization and dissemination of health-related messages
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Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring):
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2 years after randomization and dissemination of health-related messages
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Specific health outcomes
기간: 2 years after the randomization and dissemination of health-related messages
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Change in specific health outcomes (separately analysed):
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2 years after the randomization and dissemination of health-related messages
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Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology
기간: 6 months and 2 years after randomization and dissemination of health-related messages
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Change in Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology
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6 months and 2 years after randomization and dissemination of health-related messages
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Biological characteristics
기간: 2 years before and after randomization and dissemination of health-related messages
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Changes in biological results of: lipids, liver and renal functions, blood cell count, HbA1c, CRP , Blood chemistry and Blood and urine urea
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2 years before and after randomization and dissemination of health-related messages
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Impact on medical costs
기간: 2 years after randomization and dissemination of health-related messages
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Changes between groups:
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2 years after randomization and dissemination of health-related messages
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Samy Hadjadj, MD, Nantes University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC25_0253
- 2025-A01341-48 (레지스트리 식별자: IDRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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