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Completed

NCT Number: NCT02176278

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

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Forth Affiliated Hospital of China Medical University, Shengyang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Reminder

Other

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

Doctor-Nurse Follow Up

Other

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.

Personalized Risk Report for Patient Empowerment

Other

Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.

Primary outcomes

  1. Attainment of at least 3 treatment targets

    Time frame: 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)

Secondary outcomes

  1. Incidence of all-diabetes related endpoints

    Time frame: 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

Other outcomes

  1. Changes in A1c

    Time frame: 1 Year

    To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups

  2. Changes in eGFR

    Time frame: 1 Year

    To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups

  3. Use of medication

    Time frame: 1 year

    To understand the use of medications including statins, RAS inhibitors and insulin amongst the UC, EC and TEC groups

  4. Incidence of ESRD and all-cause death

    Time frame: 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

  5. Incidence of all CV events

    Time frame: 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

  6. Incidence of all-site cancer and all-cause death

    Time frame: 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

  7. Cost-effectiveness and quality of life analysis

    Time frame: 1 year

  8. Changes in lipid

    Time frame: 1 year

    To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups

  9. Changes in BP

    Time frame: 1 year

    To examine the absolute and % changes in BP amongst the UC, EC and TEC groups

  10. Changes in body weight

    Time frame: 1 year

    To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups

  11. Changes in albuminuria

    Time frame: 1 year

    To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups

Sponsors and collaborators

Lead sponsor

Asia Diabetes Foundation

Other

Registry information

Official study title

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

Acronym: DKD-TMT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2014
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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