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Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT) (DKD-TMT)

2022年4月12日 更新者:Asia Diabetes Foundation

Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT) (DKD-TMT)

In this quality improvement program (DKD-TMT), patients will be recruited from multiple sites across Asia, with each site recruiting at least 300 type 2 diabetic patients with Diabetic Kidney Disease (DKD). After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to the UC (n=100, usual care) group, the EC (n=100, empowered care) group, or the TEC (n=100, team-based, empowered care) group. Patients in all 3 groups will undergo a comprehensive assessment (CA) guided by the templates in the Joint Asia Diabetes Evaluation (JADE) portal at baseline and at month 12. They will also self-administer a set of questionnaires for assessing quality of life and psychological distress during the CA at both time points.

During the 12 months between the 2 CAs:

  • Patients in the UC group will receive UC in accordance to the practice of the health institution.
  • Patients in the EC group will receive a JADE summary report with personalized risk prediction, treatment targets and decision support with explanation from the doctor and nurse. In addition to receiving UC in accordance to the practice of the health institution, the nurse will telephone the patient 3-monthly to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns.
  • Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to achieve multiple targets, but tailored to patients' risk profile. The patients will receive telephone reminders and also be given a JADE follow up report 3-monthly.

The primary composite endpoint is attainment of treatment goals and/or control of risk factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The tertiary changes are behavioral changes, psychological well-being and quality of life.

調査の概要

詳細な説明

Hypothesis: Patient empowerment and team-based care augmented by the JADE program with features of risk stratification and decision support improves multiple risk factor control in Asian type 2 diabetic patients with chronic kidney disease. Attaining multiple treatment targets reduces all diabetes-related endpoints in these high risk patients.

Objectives: To use the JADE program which 1) includes task delegation and change in workflow augmented by 2) a web-based portal consisting of features of risk stratification, feedback, recommendations and decision support to set up a DKD registry in order to 1) document control of risk factors and care standards in real practice in Asian type 2 diabetic patients; 2) empower doctors and patients to make informed decisions and 3) use a team approach to treat to multiple targets and reduce all diabetes related clinical outcomes.

Study design: This will be a multicentre randomized translational program to compare the effects of usual care (UC) versus empowered care (EC) versus team-based, empowered care (TEC) on risk factor control and clinical outcomes in 3000 patients with DKD in Asian countries.

Intervention: All patients will undergo a comprehensive assessment (CA) guided by the templates in the JADE portal at baseline and at month 12. All patients will also self-administer a set of questionnaires for assessing quality of life (EQ-5D-3L, WHOQOL-BREF, and a Time Trade-Off (TTO) question) and psychological distress (PHQ-9 and DASS-21) during the CA at baseline and at month 12.

During the 12 months between the 2 CAs:

  • Patients in the UC group will receive UC in accordance to the practice of the health institution.
  • Patients in the EC group will receive a JADE summary report with personalized risk prediction, treatment targets and decision support with explanation from the doctor and nurse. In addition to receiving UC in accordance to the practice of the health institution, the nurse will telephone the patient 3-monthly to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns.
  • Patients in the TEC group will be followed by a doctor-nurse team at least 3 monthly to achieve multiple targets, but tailored to patients' risk profile. The patients will receive telephone reminders and also be given a JADE follow up report 3-monthly.

Outcome: The primary composite endpoint is attainment of treatment goals and/or control of risk factors. The secondary composite endpoint is all-diabetes related clinical endpoints. The tertiary changes are behavioral changes, psychological well-being and quality of life.

研究の種類

介入

入学 (実際)

2400

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Bangkok、タイ、10110
        • Theptarin Hospital
      • Ho Chi Minh、ベトナム
        • Hoa Hao MEDIC Company LMT
      • Kuala Lumpur、マレーシア
        • University Malaya Medical Centre, University of Malaya
    • Kelantan
      • Kubang Kerian、Kelantan、マレーシア
        • Universiti Sains Malysia
      • Shengyang、中国
        • The Forth Affiliated Hospital of China Medical University
      • Taipei、台湾
        • Taipei Veterans General Hospital
      • Gyeonggi-do、大韓民国
        • Hally University Dongtan Sacred Heart Hospital
      • Seoul、大韓民国、137-701
        • Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
    • Gyenonggo-do
      • Seoul、Gyenonggo-do、大韓民国
        • Bucheon St. Mary's Hospital, The Catholic University of Korea
      • Hong Kong、香港
        • Chinese University of Hong Kong, Prince of Wales Hospital
      • Hong Kong、香港
        • Department of Medicine, Alice Ho Miu Ling Nethersole Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Type 2 diabetic patients with serum creatinine above 30% upper limit of normal of the laboratory range and/or estimated glomerular filtration rate (eGFR)< 65ml/min/1.73m2; or type 2 diabetic patients with both eGFR between 60 to 90ml/min/1.73m2 and urine albumin creatinine ratio (ACR) ≥ 25 mg/mmol.
  • Willingness to return for regular follow up visits

Exclusion Criteria:

  • Inability to give informed consent
  • Life threatening condition with reduced life expectancy
  • Patients on dialysis or eGFR<15 ml/min/1.732

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
介入なし:Usual Care Group

Usual care (UC) group:

After undergoing a comprehensive assessment, all patients will receive UC in accordance to the practice of the health institution and return at 12 months for a repeat comprehensive assessment.

実験的:Empowered Care Group

Empowered care (EC) group:

After undergoing a comprehensive assessment, all patients will be given a JADE comprehensive assessment report which is a personalize risk report with treatment targets and decision support with explanation from the doctor and nurse. In addition to receiving UC in accordance to the practice of the health institution, the nurse will provide telephone reminder to patient 3-monthly to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns. All patients will return at 12 month for a repeat comprehensive assessment.

Nurse will provide telephone contact to patients every 3 month to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
実験的:Team-based, Empowered Care Group

Team-based, empowered care (TEC) group:

After undergoing a comprehensive assessment, patients randomized to the TEC group will be given a JADE comprehensive assessment report which is a personalized risk report for patient empowerment. They will receive telephone reminders and doctor-nurse follow up at least 3 monthly to achieve multiple targets recommended. The patients will also be given JADE reports 3-monthly and return at 12 month for a repeat comprehensive assessment.

Nurse will provide telephone contact to patients every 3 month to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Patient will be followed by a doctor-nurse team at least 3 monthly to achieve multiple targets recommended as A1c<7%, BP<130/80 mmHg, LDL-C<1.8 mmol/l, triglyceride<1.7 mmol/l and persistence with RAS inhibitors taking into consideration safety and tolerability (e.g. hypoglycemia, hypotension, changes in electrolytes). Patient report will be given after follow up.

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
Attainment of at least 3 treatment targets
時間枠:1 year

Attainment of at least 3 treatment targets of

  • A1c<7%
  • BP<130/80 mmHg
  • LDL-C<1.8 mmol/L
  • Triglyceride<1.7 mmol/L
  • Persistence with RAS inhibitors taking into consideration safety and tolerability (e.g. hypoglycemia, hypotension, changes in electrolytes)
1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of all-diabetes related endpoints
時間枠:1 year
Incidence of all-diabetes related endpoints (vascular, cancer, non-vascular non-cancer and all-cause death) between patients who attain at least 3 targets versus those who do not
1 year

その他の成果指標

結果測定
メジャーの説明
時間枠
Changes in A1c
時間枠:1 Year
To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups
1 Year
Changes in eGFR
時間枠:1 Year
To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups
1 Year
Use of medication
時間枠:1 year
To understand the use of medications including statins, RAS inhibitors and insulin amongst the UC, EC and TEC groups
1 year
Incidence of ESRD and all-cause death
時間枠:1 year
To examine the difference of incidence of ESRD and all-cause death between patients who are treated to multiple targets and those who are not
1 year
Incidence of all CV events
時間枠:1 year
To investiage the difference of incidence of all CV events including stroke, acute myocardial infarction, heart failure, acute coronary syndrome, all-cause death between patients who are treated to multiple targets and those who are not
1 year
Incidence of all-site cancer and all-cause death
時間枠:1 year
To examine incidence of all-site cancer and all-cause death between patients who are treated to multiple targets and those who are not
1 year
Cost-effectiveness and quality of life analysis
時間枠:1 year
1 year
Changes in lipid
時間枠:1 year
To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups
1 year
Changes in BP
時間枠:1 year
To examine the absolute and % changes in BP amongst the UC, EC and TEC groups
1 year
Changes in body weight
時間枠:1 year
To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups
1 year
Changes in albuminuria
時間枠:1 year
To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups
1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Juliana CN Chan, MD、Asia Diabetes Foundation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年6月1日

一次修了 (実際)

2019年2月1日

研究の完了 (実際)

2019年2月1日

試験登録日

最初に提出

2014年4月28日

QC基準を満たした最初の提出物

2014年6月26日

最初の投稿 (見積もり)

2014年6月27日

学習記録の更新

投稿された最後の更新 (実際)

2022年4月19日

QC基準を満たした最後の更新が送信されました

2022年4月12日

最終確認日

2022年4月1日

詳しくは

本研究に関する用語

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?

いいえ

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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