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

April 12, 2022 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shengyang, China
        • The Forth Affiliated Hospital of China Medical University
  • 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
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Hally University Dongtan Sacred Heart Hospital
      • Seoul, Korea, Republic of, 137-701
        • Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
    • Gyenonggo-do
      • Seoul, Gyenonggo-do, Korea, Republic of
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Other: 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
Other: Personalized Risk Report for Patient Empowerment
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.
Other: 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
Other: Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in A1c
Time Frame: 1 Year
To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups
1 Year
Changes in eGFR
Time Frame: 1 Year
To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups
1 Year
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
1 year
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
1 year
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
1 year
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
1 year
Cost-effectiveness and quality of life analysis
Time Frame: 1 year
1 year
Changes in lipid
Time Frame: 1 year
To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups
1 year
Changes in BP
Time Frame: 1 year
To examine the absolute and % changes in BP amongst the UC, EC and TEC groups
1 year
Changes in body weight
Time Frame: 1 year
To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups
1 year
Changes in albuminuria
Time Frame: 1 year
To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asia Diabetes Foundation

Investigators

  • Principal Investigator: Juliana CN Chan, MD, Asia Diabetes Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2013.609-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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