Comparing the Effect of Structured Care Versus Usual Care in Type 2 Diabetes Patients Across the Asia Pacific Region (AP-JD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Asia Diabetes Foundation
Sponsor:
Information provided by (Responsible Party):
Asia Diabetes Foundation
ClinicalTrials.gov Identifier:
NCT01631084
First received: June 27, 2012
Last updated: July 6, 2014
Last verified: July 2014

June 27, 2012
July 6, 2014
April 2012
June 2016   (final data collection date for primary outcome measure)
Incidence of all diabetes-related clinical endpoints [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  1. cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions)
  2. chronic kidney disease (eGFR<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR<15 ml/min/1.73m2)
  3. visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery
  4. lower extremity amputation or foot ulcers requiring hospitalizations
  5. major infections - pulmonary and non-pulmonary requiring hospitalizations
  6. all-site cancers
  7. death
Same as current
Complete list of historical versions of study NCT01631084 on ClinicalTrials.gov Archive Site
Proportions of patients with improved control of risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

a) 2 or more of the 'ABC' targets: i) HbA1c<7%, ii) BP<130/80 mmHg, iii) LDL-C <2.6 mmol/L.

b) and/or

c) 2 of the following changes in risk factor control: i) at least 0.5% reduction in HbA1c, ii) at least 5 mmHg reduction in systolic BP, iii) at least 0.5 mmol/L reduction in LDL-C, iv) at least 3% reduction in body weight.

Same as current
Not Provided
Not Provided
 
Comparing the Effect of Structured Care Versus Usual Care in Type 2 Diabetes Patients Across the Asia Pacific Region
A Multicentre Randomized Program to Compare the Effect of the Joint Asia Diabetes Evaluation (JADE, Structured Care) Versus the DIAbetes MONitoring Database (DIAMOND, Usual Care) Programs in Type 2 Diabetes in the Asia Pacific Region

In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short) supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care) group.

All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter. Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a protocol based on risk stratification with predefined follow up (FU) schedules together with shared information and decision support (i.e. structured collaborative care). The DIAMOND protocol involves only baseline and yearly CA without predefined FU schedules or feedback of information between CA visits (i.e. usual care).

The primary composite endpoint is all-diabetes related clinical endpoints. The secondary composite endpoint is attainment of treatment goals and/or control of risk factors. The tertiary changes are behavioral changes, psychological well being and quality of life.

Rationale: Change of practice environment and an interdisciplinary team is needed to implement evidence-based diabetes care which requires risk stratification, periodic assessments, education and treatment to targets.

Hypothesis: The use of a web-based disease management program (Joint Asia Diabetes Evaluation (JADE) Program) delivered by a doctor-nurse-HCA team reduces the incidence of all diabetes-associated clinical endpoint and improves control of risk factors compared to usual care (DIAbetes MONitoring Database (DIAMOND) group) in type 2 diabetes.

Objective: To compare structured care using the JADE portal versus usual care using the DIAMOND portal on incidence of all-diabetes related events, physical and psychological health.

Study design: A multicentre, randomized, integrated disease management program Setting and patients: 600 patients from each site will be randomized to the JADE group (n=300) or the DIAMOND group (n=300) and followed up for at least 24 months.

Intervention: All patients will undergo comprehensive assessment (CA) guided by the templates in the respective portal at baseline, month 12 and 24. The JADE group will be further managed by a doctor-nurse-HCA team guided by the JADE portal with risk stratification program and recommendation to different care protocols with predefined follow up (FU) schedules, information sharing and decision supports.

Outcome measures: Primary composite outcomes include all diabetes-related clinical events; secondary composite outcomes include control of risk factors and tertiary composite outcomes include behavioral changes, psychological health, quality of life and cost-effective analysis.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • Other: JADE

    Patients are booked for reviews led by the doctor-nurse-HCA team every 2-4 months, preferably in a setting different from the busy clinics in order to facilitate group education and promote peer support.

    Between each follow-up visit, the nurse or HCA will contact the patient by phone or email to remind them of the appointments (e.g. medical FU visit or laboratory tests), adhere to medications and healthy lifestyles, perform self glucose monitoring and provide psychosocial support, as appropriate.

  • Other: DIAMOND
    Patients randomized to the DIAMOND group will receive usual care after the initial baseline comprehensive assessment (CA), with repeat CA at 12 and 24 months.
  • Experimental: JADE
    Patients randomized to the JADE group will be followed according to protocol-driven diabetes care based on their individual risk levels, using a web-based disease management program. In addition to their annual comprehensive assessments at baseline, year 1 and year 2, all subsequent follow-up visits will be documented and entered into the JADE portal, which will then issue reports to both patients and doctor to promote sharing of information and informed decisions.
    Intervention: Other: JADE
  • Active Comparator: DIAMOND
    Patients will receive a comprehensive assessment at baseline, year 1 and year 2. In the interim between these time points patients will be managed according to 'usual care' procedures.
    Intervention: Other: DIAMOND

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50000
December 2017
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetic patients who are willing or can be persuaded to return for 'regular' follow-up at 3-4 monthly intervals
  • Patients with newly diagnosed or established disease, treated with lifestyle modification or blood glucose lowering drugs including oral agents with or without insulin
  • For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be:

    • Fasting plasma glucose (PG) >7.0 mmol/L on 2 or more occasions, and/or
    • Random or 2-hour PG >11.1 mmol/L (after 75 gram oral glucose tolerance test) on 2 or more occasions, and/or
    • HbA1c >6.5%

Exclusion Criteria:

  • Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis
  • Patients with reduced life expectancy (e.g. less than 6 months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life-threatening conditions
  • Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
  • Patients actively enrolled in another intervention study
  • Patients who are unwilling to return for regular follow up.
Both
18 Years and older
No
Contact: Juliana Chan, MD jchan@cuhk.edu.hk
Contact: Nicola Brown, MSc nicolabrown@adf.org.hk
Hong Kong
 
NCT01631084
CRE-2012.199-T
Yes
Asia Diabetes Foundation
Asia Diabetes Foundation
Not Provided
Principal Investigator: Juliana Chan, MD Asia Diabetes Foundation
Asia Diabetes Foundation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP