Clinical trial NCT02176278: Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT)
Official title: Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT) (DKD-TMT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Kidney Disease
Keywords: Diabetic Kidney Disease
Diabetes
Asian
Joint Asia Diabetes Evaluation (JADE) Program
Lead sponsor: Asia Diabetes Foundation
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 2400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attainment of at least 3 treatment targets
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of all-diabetes related endpoints
timeFrame: 1 year
Other outcomes:
measure: Changes in A1c
timeFrame: 1 Year
measure: Changes in eGFR
timeFrame: 1 Year
measure: Use of medication
timeFrame: 1 year
measure: Incidence of ESRD and all-cause death
timeFrame: 1 year
measure: Incidence of all CV events
timeFrame: 1 year
measure: Incidence of all-site cancer and all-cause death
timeFrame: 1 year
measure: Cost-effectiveness and quality of life analysis
timeFrame: 1 year
measure: Changes in lipid
timeFrame: 1 year
measure: Changes in BP
timeFrame: 1 year
measure: Changes in body weight
timeFrame: 1 year
measure: Changes in albuminuria
timeFrame: 1 year
Locations:
city: Shengyang
country: China
facility: The Forth Affiliated Hospital of China Medical University
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong, Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, Alice Ho Miu Ling Nethersole Hospital
city: Seoul
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital, The Catholic University of Korea
state: Gyenonggo-do
city: Gyeonggi-do
country: Korea, Republic of
facility: Hally University Dongtan Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malysia
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre, University of Malaya
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Theptarin Hospital
city: Ho Chi Minh
country: Vietnam
facility: Hoa Hao MEDIC Company LMT
Study officials:
affiliation: Asia Diabetes Foundation
name: Juliana CN Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1136/bmj.38905.447118.2F. Epub 2006 Aug 17.
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. doi: 10.1016/j.amjmed.2005.07.050.
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. doi: 10.1093/ndt/gfh408. Epub 2004 Jul 27.
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.
citation: 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.