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

12 de abril de 2022 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2400

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Gyeonggi-do, Corea, república de
        • Hally University Dongtan Sacred Heart Hospital
      • Seoul, Corea, república de, 137-701
        • Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
    • Gyenonggo-do
      • Seoul, Gyenonggo-do, Corea, república de
        • Bucheon St. Mary's Hospital, The Catholic University of Korea
      • 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
      • Kuala Lumpur, Malasia
        • University Malaya Medical Centre, University of Malaya
    • Kelantan
      • Kubang Kerian, Kelantan, Malasia
        • Universiti Sains Malysia
      • Shengyang, Porcelana
        • The Forth Affiliated Hospital of China Medical University
      • Bangkok, Tailandia, 10110
        • Theptarin Hospital
      • Taipei, Taiwán
        • Taipei Veterans General Hospital
      • Ho Chi Minh, Vietnam
        • Hoa Hao MEDIC Company LMT

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.

Experimental: 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.
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Attainment of at least 3 treatment targets
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of all-diabetes related endpoints
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in A1c
Periodo de tiempo: 1 Year
To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups
1 Year
Changes in eGFR
Periodo de tiempo: 1 Year
To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups
1 Year
Use of medication
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year
1 year
Changes in lipid
Periodo de tiempo: 1 year
To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups
1 year
Changes in BP
Periodo de tiempo: 1 year
To examine the absolute and % changes in BP amongst the UC, EC and TEC groups
1 year
Changes in body weight
Periodo de tiempo: 1 year
To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups
1 year
Changes in albuminuria
Periodo de tiempo: 1 year
To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Juliana CN Chan, MD, Asia Diabetes Foundation

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2014

Finalización primaria (Actual)

1 de febrero de 2019

Finalización del estudio (Actual)

1 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2014

Publicado por primera vez (Estimar)

27 de junio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

12 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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