Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT)
NCT ID: NCT02176278
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2400 participants
INTERVENTIONAL
2014-06-30
2019-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual Care Group
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.
No interventions assigned to this group
Empowered Care Group
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.
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
Personalized Risk Report for Patient Empowerment
Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
Team-based, Empowered Care Group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Willingness to return for regular follow up visits
Exclusion Criteria
* Life threatening condition with reduced life expectancy
* Patients on dialysis or eGFR\<15 ml/min/1.732
ALL
No
Sponsors
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Asia Diabetes Foundation
OTHER
Responsible Party
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Principal Investigators
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Juliana CN Chan, MD
Role: PRINCIPAL_INVESTIGATOR
Asia Diabetes Foundation
Locations
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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, , South Korea
Taipei Veterans General Hospital
Taipei, , Taiwan
Theptarin Hospital
Bangkok, , Thailand
Hoa Hao MEDIC Company LMT
Ho Chi Minh City, , Vietnam
Countries
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References
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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.
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.
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. doi: 10.1136/bmj.38905.447118.2F. Epub 2006 Aug 17.
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. doi: 10.1016/j.amjmed.2005.07.050.
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. doi: 10.1093/ndt/gfh408. Epub 2004 Jul 27.
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.
Chan 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.
Related Links
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Asia Diabetes Foundation
Other Identifiers
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CRE-2013.609-T
Identifier Type: -
Identifier Source: org_study_id
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