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

12. dubna 2022 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

2400

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Hongkong
      • Hong Kong, Hongkong
        • Chinese University of Hong Kong, Prince of Wales Hospital
      • Hong Kong, Hongkong
        • Department of Medicine, Alice Ho Miu Ling Nethersole Hospital
  • Korejská republika
      • Gyeonggi-do, Korejská republika
        • Hally University Dongtan Sacred Heart Hospital
      • Seoul, Korejská republika, 137-701
        • Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
    • Gyenonggo-do
      • Seoul, Gyenonggo-do, Korejská republika
        • Bucheon St. Mary's Hospital, The Catholic University of Korea
  • Malajsie
      • Kuala Lumpur, Malajsie
        • University Malaya Medical Centre, University of Malaya
    • Kelantan
      • Kubang Kerian, Kelantan, Malajsie
        • Universiti Sains Malysia
  • Tchaj-wan
      • Taipei, Tchaj-wan
        • Taipei Veterans General Hospital
  • Thajsko
      • Bangkok, Thajsko, 10110
        • Theptarin Hospital
  • Vietnam
      • Ho Chi Minh, Vietnam
        • Hoa Hao MEDIC Company LMT
  • Čína
      • Shengyang, Čína
        • The Forth Affiliated Hospital of China Medical University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: 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.
Experimentální: 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.
Jiný: Telephone Reminder
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
Jiný: Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Experimentální: 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.
Jiný: Telephone Reminder
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
Jiný: Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Jiný: Doctor-Nurse Follow Up
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Attainment of at least 3 treatment targets
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of all-diabetes related endpoints
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in A1c
Časové okno: 1 Year
To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups
1 Year
Changes in eGFR
Časové okno: 1 Year
To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups
1 Year
Use of medication
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 1 year
1 year
Changes in lipid
Časové okno: 1 year
To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups
1 year
Changes in BP
Časové okno: 1 year
To examine the absolute and % changes in BP amongst the UC, EC and TEC groups
1 year
Changes in body weight
Časové okno: 1 year
To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups
1 year
Changes in albuminuria
Časové okno: 1 year
To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups
1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Asia Diabetes Foundation

Vyšetřovatelé

  • Vrchní vyšetřovatel: Juliana CN Chan, MD, Asia Diabetes Foundation

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2014

Primární dokončení (Aktuální)

1. února 2019

Dokončení studie (Aktuální)

1. února 2019

Termíny zápisu do studia

První předloženo

28. dubna 2014

První předloženo, které splnilo kritéria kontroly kvality

26. června 2014

První zveřejněno (Odhad)

27. června 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. dubna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. dubna 2022

Naposledy ověřeno

1. dubna 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CRE-2013.609-T

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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