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

Asia Diabetes Foundation

Status: Completed

Conditions: Diabetic Kidney Disease

Treatments: Other: Telephone Reminder; Other: Doctor-Nurse Follow Up; Other: Personalized Risk Report for Patient Empowerment

Study type: Interventional

Funder types: Other

Identifiers

NCT02176278

CRE-2013.609-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,400 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,400 participants in 3 patient groups

Usual Care Group

No Intervention group

Description:

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.

Empowered Care Group

Experimental group

Description:

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.

Treatment:

Other: Personalized Risk Report for Patient Empowerment

Other: Telephone Reminder

Team-based, Empowered Care Group

Experimental group

Description:

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.

Treatment:

Other: Doctor-Nurse Follow Up

Other: Personalized Risk Report for Patient Empowerment

Other: Telephone Reminder