Diabetic Kidney Disease
Conditions
Keywords
Diabetic Kidney Disease, Diabetes, Asian, Joint Asia Diabetes Evaluation (JADE) Program
Brief 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.
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.
Interventions
OTHERTelephone 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
OTHERDoctor-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.
OTHERPersonalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Sponsors
Asia Diabetes Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attainment of at least 3 treatment targets | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-diabetes related endpoints | 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
| Measure | Time frame | Description |
|---|---|---|
| Use of medication | 1 year | To understand the use of medications including statins, RAS inhibitors and insulin amongst the UC, EC and TEC groups |
| Incidence of ESRD and all-cause death | 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 |
| Incidence of all CV events | 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 |
| Incidence of all-site cancer and all-cause death | 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 |
| Changes in A1c | 1 Year | To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups |
| Changes in lipid | 1 year | To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups |
| Changes in BP | 1 year | To examine the absolute and % changes in BP amongst the UC, EC and TEC groups |
| Changes in body weight | 1 year | To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups |
| Changes in albuminuria | 1 year | To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups |
| Cost-effectiveness and quality of life analysis | 1 year | — |
| Changes in eGFR | 1 Year | To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups |
Countries
China, Hong Kong, Malaysia, South Korea, Taiwan, Thailand, Vietnam
Outcome results
None listed