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
  Purpose

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.


Condition Intervention
Diabetes
Other: JADE
Other: DIAMOND

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Asia Diabetes Foundation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 50000
Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631084

Contacts
Contact: Juliana Chan, MD jchan@cuhk.edu.hk
Contact: Nicola Brown, MSc nicolabrown@adf.org.hk

Locations
Hong Kong
Asia Diabetes Foundation Recruiting
Shatin, Hong Kong
Contact: Juliana Chan, MD         
Sponsors and Collaborators
Asia Diabetes Foundation
Investigators
Principal Investigator: Juliana Chan, MD Asia Diabetes Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Asia Diabetes Foundation
ClinicalTrials.gov Identifier: NCT01631084     History of Changes
Other Study ID Numbers: CRE-2012.199-T
Study First Received: June 27, 2012
Last Updated: July 6, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Resarch Ethics Committee
Singapore: Singapore General Hospital Ethics Committee
India: Clinical Ethics Forum, Mumbai for site requiring independent EC approval

Keywords provided by Asia Diabetes Foundation:
Diabetes
Structured care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014