Kidney AI-enabled Care Transformation
調査の概要
詳細な説明
The Advancing American Kidney Health (AAKH) initiative has the goal of an ambitious 25% reduction of ESRD incidence by 2030. There is a lack of successful integrated care programs to reach this goal. The CKD population is very heterogeneous, this explains the different risk of progression to ESRD in different patients. However, Guidelines (GLs) for the treatment of CKD patients address risk factors identified in the CKD population at large. Thus, all CKD patients at the same stage receive similar treatments no matter the specific risk of developing ESRD. Up to 5.9% of Europeans have CKD stages 3-5. Treating this huge number of patients would strain health systems from both the organizational and economical point of view. It is reasonable to think that dedicating a personalized management specifically to CKD patients at high risk of progression would be cost-effective.
GLs include behavioral (e.g. lifestyle, nutrition) as well as medical (e.g. drug therapy) interventions. Although patient's engagement and empowerment play a pivotal role in successful disease treatment, there is lack of evidence on practices to foster them in CKD patients.
Kidney ACTion is a program that supports nephrologists in predicting disease progression for CKD patients and developing multidisciplinary, personalized, evidence-based treatment and care plans. Patient engagement and empowerment is a fundamental part of the program.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Alexander H Kirsch, MD
- 電話番号:12170 +43316385
- メール:alexander.kirsch@medunigraz.at
研究連絡先のバックアップ
- 名前:Kathrin Eller, MD
- 電話番号:12170 +43316385
- メール:kathrin.eller@medunigraz.at
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female aged ≥18 years at the time of signing the informed consent
- Chronic kidney disease with eGFR <45 mL/min/1.73 m2 and UACR >300 mg/g creatinine (eGFR=estimated glomerular filtration rate; UACR=Urine Albumin-to-Creatinine Ratio)
- Patient is willing to comply with the study requirements for therapy during the entire study period
- Patient is capable of providing written informed consent to participate in the study
Exclusion Criteria:
- Patients with underlying renal disease likely to receive disease-specific therapy other than SoC (Standard of Care)
- Patient expected to require renal replacement therapy within less than one year from study 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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Standard of care
CKD care, as routinely provided in the respective nephrology outpatient clinic.
|
標準治療
|
実験的:Intervention
standard of care + Kidney ACTion AI-supported software for chronic kidney disease care.
|
AI-supported software for chronic kidney disease care
|
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 |
---|---|---|
Urinary Albumin to Creatinine Ratio (UACR)
時間枠:1 year after start of treatment
|
Urine Albumin (mg/dL) / Urine Creatinine (g/dL) = UACR in mg/g ≈ Albumin excretion in mg/day
|
1 year after start of treatment
|
協力者と研究者
協力者
捜査官
- 主任研究者:Alexander H Kirsch, MD、Medical University of Graz
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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