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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Kidney Disease

Intervention / Treatment
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* Other: Telephone Reminder
* Other: Doctor-Nurse Follow Up
* Other: Personalized Risk Report for Patient Empowerment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>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<br>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<br>* 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<br>Other: Personalized Risk Report for Patient Empowerment<br>* Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.<br>|
| Experimental: Team-based, Empowered Care Group<br>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<br>* 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<br>Other: Doctor-Nurse Follow Up<br>* 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.<br>Other: Personalized Risk Report for Patient Empowerment<br>* Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment of at least 3 treatment targets | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Kidney Disease, Diabetes, Asian, Joint Asia Diabetes Evaluation (JADE) Program