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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Samy Hadjadj, PU-PH
- 電話番号：+33244768545 +33244768545
- メール：samy.hadjadj@univ-nantes.fr
研究連絡先のバックアップ
- 名前：Sonia Brinet
- 電話番号：+33253526126
- メール：sonia.brinet@chu-nantes.fr
研究場所
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Nantes、フランス、44000
- Biogroup laboratories
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コンタクト：
- Claire Vignault, MD
- 電話番号：0645644018
- メール：claire.vignault@biogroup.fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：Control group
Participants will get as in the routine care, no message will be disseminated for this group.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Major Adverse Renal and Cardiovascular Events (MARCE) occurrence
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Specific health outcomes
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
協力者
捜査官
- 主任研究者：Samy Hadjadj, MD、Nantes University Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RC25_0253
- 2025-A01341-48 (レジストリ識別子：IDRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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