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

12. april 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Andet: 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
Andet: Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Eksperimentel: 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.
Andet: 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
Andet: Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Attainment of at least 3 treatment targets
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of all-diabetes related endpoints
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in A1c
Tidsramme: 1 Year
To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups
1 Year
Changes in eGFR
Tidsramme: 1 Year
To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups
1 Year
Use of medication
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
1 year
Changes in lipid
Tidsramme: 1 year
To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups
1 year
Changes in BP
Tidsramme: 1 year
To examine the absolute and % changes in BP amongst the UC, EC and TEC groups
1 year
Changes in body weight
Tidsramme: 1 year
To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups
1 year
Changes in albuminuria
Tidsramme: 1 year
To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Asia Diabetes Foundation

Efterforskere

  • Ledende efterforsker: Juliana CN Chan, MD, Asia Diabetes Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2014

Primær færdiggørelse (Faktiske)

1. februar 2019

Studieafslutning (Faktiske)

1. februar 2019

Datoer for studieregistrering

Først indsendt

28. april 2014

Først indsendt, der opfyldte QC-kriterier

26. juni 2014

Først opslået (Skøn)

27. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRE-2013.609-T

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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