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

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ClinicalTrials.gov Identifier: NCT02176278
Recruitment Status : Active, not recruiting
First Posted : June 27, 2014
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Asia Diabetes Foundation

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.


Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Other: Telephone Reminder Other: Doctor-Nurse Follow Up Other: Personalized Risk Report for Patient Empowerment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using a Diabetic Kidney Disease (DKD) Registry to Treat to Multiple Targets (TMT) (DKD-TMT)
Study Start Date : May 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.

Experimental: 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.

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

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

Experimental: 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.

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

Other: 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.

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




Primary Outcome Measures :
  1. Attainment of at least 3 treatment targets [ Time Frame: 1 year ]

    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)


Secondary Outcome Measures :
  1. Incidence of all-diabetes related endpoints [ Time Frame: 1 year ]
    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


Other Outcome Measures:
  1. Changes in A1c [ Time Frame: 1 Year ]
    To examine the absolute and % changes in A1c amongst the UC, EC and TEC groups

  2. Changes in eGFR [ Time Frame: 1 Year ]
    To examine the absolute and % changes in eGFR amongst the UC, EC and TEC groups

  3. Use of medication [ Time Frame: 1 year ]
    To understand the use of medications including statins, RAS inhibitors and insulin amongst the UC, EC and TEC groups

  4. Incidence of ESRD and all-cause death [ Time Frame: 1 year ]
    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

  5. Incidence of all CV events [ Time Frame: 1 year ]
    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

  6. Incidence of all-site cancer and all-cause death [ Time Frame: 1 year ]
    To examine incidence of all-site cancer and all-cause death between patients who are treated to multiple targets and those who are not

  7. Cost-effectiveness and quality of life analysis [ Time Frame: 1 year ]
  8. Changes in lipid [ Time Frame: 1 year ]
    To examine the absolute and % changes in lipids amongst the UC, EC and TEC groups

  9. Changes in BP [ Time Frame: 1 year ]
    To examine the absolute and % changes in BP amongst the UC, EC and TEC groups

  10. Changes in body weight [ Time Frame: 1 year ]
    To exmine the absolute and % changes in body weight amongst the UC, EC and TEC groups

  11. Changes in albuminuria [ Time Frame: 1 year ]
    To exmine the absolute and % changes albuminuria amongst the UC, EC and TEC groups



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176278


Locations
China
The Forth Affiliated Hospital of China Medical University
Shengyang City, China
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, Hong Kong
Korea, Republic of
Seoul St.Mary's Hospital, The Catholic Unviersity of Korea
Seocho-Gu, Seoul, Korea, Republic of, 137-701
Bucheon St. Mary's Hospital, The Catholic University of Korea
Gyenonggo-do, Korea, Republic of
Hally University Dongtan Sacred Heart Hospital
Gyeonggido, Korea, Republic of
Malaysia
Universiti Sains Malysia
Kelantan, Malaysia
University Malaya Medical Centre, University of Malaya
Kuala Lumpur, Malaysia
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Thailand
Theptarin Hospital
Bangkok, Thailand, 10110
Vietnam
Hoa Hao MEDIC Company LMT
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Asia Diabetes Foundation
Investigators
Principal Investigator: Juliana CN Chan, MD Asia Diabetes Foundation

Additional Information:
Publications:

Responsible Party: Asia Diabetes Foundation
ClinicalTrials.gov Identifier: NCT02176278     History of Changes
Other Study ID Numbers: CRE-2013.609-T
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Asia Diabetes Foundation:
Diabetic Kidney Disease
Diabetes
Asian
Joint Asia Diabetes Evaluation (JADE) Program

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases