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

Diabetic Kidney Disease Clinical Trial

— DKD-TMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176278
• Other study ID #: CRE-2013.609-T
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: February 2019

Study information

• Verified date: April 2022
• Source: Asia Diabetes Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

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
• 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.
• Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.

Locations

Country	Name	City	State
China	The Forth Affiliated Hospital of China Medical University	Shengyang
Hong Kong	Chinese University of Hong Kong, Prince of Wales Hospital	Hong Kong
Hong Kong	Department of Medicine, Alice Ho Miu Ling Nethersole Hospital	Hong Kong
Korea, Republic of	Hally University Dongtan Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Bucheon St. Mary's Hospital, The Catholic University of Korea	Seoul	Gyenonggo-do
Korea, Republic of	Seoul St.Mary's Hospital, The Catholic Unviersity of Korea	Seoul
Malaysia	University Malaya Medical Centre, University of Malaya	Kuala Lumpur
Malaysia	Universiti Sains Malysia	Kubang Kerian	Kelantan
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Theptarin Hospital	Bangkok
Vietnam	Hoa Hao MEDIC Company LMT	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Asia Diabetes Foundation

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of,  Malaysia,  Taiwan,  Thailand,  Vietnam, 

References & Publications (6)

Chan J, So W, Ko G, Tong P, Yang X, Ma R, Kong A, Wong R, Le Coguiec F, Tamesis B, Wolthers T, Lyubomirsky G, Chow P. The Joint Asia Diabetes Evaluation (JADE) Program: a web-based program to translate evidence to clinical practice in Type 2 diabetes. Diabet Med. 2009 Jul;26(7):693-9. doi: 10.1111/j.1464-5491.2009.02751.x. — View Citation

Chan JC, So WY, Yeung CY, Ko GT, Lau IT, Tsang MW, Lau KP, Siu SC, Li JK, Yeung VT, Leung WY, Tong PC; SURE Study Group. Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study. Diabetes Care. 2009 Jun;32(6):977-82. doi: 10.2337/dc08-1908. — View Citation

Chan JC, Sui Y, Oldenburg B, Zhang Y, Chung HH, Goggins W, Au S, Brown N, Ozaki R, Wong RY, Ko GT, Fisher E; JADE and PEARL Project Team. Effects of telephone-based peer support in patients with type 2 diabetes mellitus receiving integrated care: a randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):972-81. doi: 10.1001/jamainternmed.2014.655. — View Citation

Leung WY, So WY, Tong PC, Chan NN, Chan JC. Effects of structured care by a pharmacist-diabetes specialist team in patients with type 2 diabetic nephropathy. Am J Med. 2005 Dec;118(12):1414. — View Citation

Leung WY, So WY, Tong PC, Lo MK, Lee KF, Ko GT, Chan WB, Cockram CS, Brenner BM, Shahinfar S, Critchley JA, Chan JC. The renoprotective effects of structured care in a clinical trial setting in type 2 diabetic patients with nephropathy. Nephrol Dial Transplant. 2004 Oct;19(10):2519-25. Epub 2004 Jul 27. — View Citation

Wu JY, Leung WY, Chang S, Lee B, Zee B, Tong PC, Chan JC. Effectiveness of telephone counselling by a pharmacist in reducing mortality in patients receiving polypharmacy: randomised controlled trial. BMJ. 2006 Sep 9;333(7567):522. Epub 2006 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in A1c	To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups	1 Year
Other	Changes in eGFR	To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups	1 Year
Other	Use of medication	To understand the use of medications including statins, RAS inhibitors and insulin amongst the UC, EC and TEC groups	1 year
Other	Incidence of ESRD and all-cause death	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
Other	Incidence of all CV events	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
Other	Incidence of all-site cancer and all-cause death	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
Other	Cost-effectiveness and quality of life analysis		1 year
Other	Changes in lipid	To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups	1 year
Other	Changes in BP	To examine the absolute and % changes in BP amongst the UC, EC and TEC groups	1 year
Other	Changes in body weight	To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups	1 year
Other	Changes in albuminuria	To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups	1 year
Primary	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	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

External Links

•   Asia Diabetes Foundation
•   JAMA Network Open: Effect of a Web-Based Management Guide on Risk Factors in Patients With Type 2 Diabetes and Diabetic Kidney Disease