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

Summary

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.

Conditions

• Diabetic Kidney Disease

Interventions

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

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.

OTHER

Personalized Risk Report for Patient Empowerment

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

Sponsors & Collaborators

• Asia Diabetes Foundation

  lead OTHER

Principal Investigators

• Juliana CN Chan, MD · Asia Diabetes Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2019-02-28

Completion

2019-02-28

Countries

• China
• Hong Kong
• Malaysia
• South Korea
• Taiwan
• Thailand
• Vietnam

Study Locations