Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT)
DKD-TMT
1 other identifier
interventional
2,400
7 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedApril 19, 2022
April 1, 2022
4.7 years
April 28, 2014
April 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of all-diabetes related endpoints
1 year
Other Outcomes (11)
Changes in A1c
1 Year
Changes in eGFR
1 Year
Use of medication
1 year
- +8 more other outcomes
Study Arms (3)
Usual Care Group
NO INTERVENTIONUsual 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
EXPERIMENTALEmpowered 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.
Team-based, Empowered Care Group
EXPERIMENTALTeam-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.
Interventions
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
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.
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to give informed consent
- Life threatening condition with reduced life expectancy
- Patients on dialysis or eGFR\<15 ml/min/1.732
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The Forth Affiliated Hospital of China Medical University
Shengyang, China
Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
Department of Medicine, Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
Universiti Sains Malysia
Kubang Kerian, Kelantan, Malaysia
University Malaya Medical Centre, University of Malaya
Kuala Lumpur, Malaysia
Bucheon St. Mary's Hospital, The Catholic University of Korea
Seoul, Gyenonggo-do, South Korea
Hally University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
Seoul, 137-701, South Korea
Taipei Veterans General Hospital
Taipei, Taiwan
Theptarin Hospital
Bangkok, 10110, Thailand
Hoa Hao MEDIC Company LMT
Ho Chi Minh City, Vietnam
Related Publications (7)
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.
PMID: 19573118BACKGROUNDChan 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.
PMID: 19460913BACKGROUNDWu 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. doi: 10.1136/bmj.38905.447118.2F. Epub 2006 Aug 17.
PMID: 16916809BACKGROUNDLeung 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. doi: 10.1016/j.amjmed.2005.07.050.
PMID: 16378791BACKGROUNDLeung 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. doi: 10.1093/ndt/gfh408. Epub 2004 Jul 27.
PMID: 15280527BACKGROUNDChan 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.
PMID: 24781960BACKGROUNDChan JCN, Thewjitcharoen Y, Nguyen TK, Tan A, Chia YC, Hwu CM, Jian D, Himathongkam T, Wong KL, Choi YM, Mirasol R, Mohamed M, Kong APS, Ma RCW, Chow EYK, Ozaki R, Lau V, Fu AWC, Hong EG, Yoon KH, Tsang CC, Lau ESH, Lim LL, Luk AOY. Effect of a Web-Based Management Guide on Risk Factors in Patients With Type 2 Diabetes and Diabetic Kidney Disease: A JADE Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e223862. doi: 10.1001/jamanetworkopen.2022.3862.
PMID: 35333363DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliana CN Chan, MD
Asia Diabetes Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
June 27, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
April 19, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share