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The Joint Asia Diabetes Evaluation (JADE) Program in Hong Kong Community (JADE1)

This study is currently recruiting participants.
Verified January 2011 by Chinese University of Hong Kong
Sponsor:
Collaborator:
Asia Diabetes Foundation
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00711152
First received: July 7, 2008
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose
  1. To recruit 600 type 2 diabetic patients managed in a community setting.
  2. To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.
  3. After the comprehensive assessment at enrolment, half of the patients will be managed according to the JADE protocol implemented with assistance of a clinic nurse. The other half of the patients will be managed in the usual manner.
  4. At the end of 1 year, all patients will undergo repeat comprehensive assessments for comparison of attainment of treatment targets.
  5. The acceptability of the JADE Program by patients and clinic staff will also be evaluated.

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Other: Protocol-driven care under JADE Program
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Implementation Project to Evaluate the Effectiveness and Acceptability of the Joint Asia Diabetes Evaluation (JADE) Program in Hong Kong Chinese Type 2 Diabetic Patients In a Community Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Change in glycated hemoglobin level [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effectiveness and user-acceptability of the internet on-line and computer record system (JADE) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Study doctors are using JADE Program to enhance implementation of protocol-driven care to the enrolled diabetic patients
 Other: Protocol-driven care under JADE Program
The JADE Program uses world-class information technology to facilitate evidence-based clinical protocol by a multidisciplinary team. There is an internet on-line and computer record system in the day-to-day management of people with diabetes.
B
Usual Care: This arm of patients is managed as usual, without the help of JADE Program
 Other: Protocol-driven care under JADE Program
The JADE Program uses world-class information technology to facilitate evidence-based clinical protocol by a multidisciplinary team. There is an internet on-line and computer record system in the day-to-day management of people with diabetes.

Detailed Description:

Several lines of evidence support protocol-driven care using a multidisciplinary approach with special focus on periodic assessments, reinforcement of compliance and attainment of treatment targets improves risk factor control and reduces morbidity and mortality in people with diabetes mellitus The Joint Asia Diabetes Evaluation (JADE) Program is an innovative project using state of the art information technology with internet on-line system to enable doctors, nurses and other medical personnel to manage people with diabetes. It provides a virtual platform to facilitate implementation of evidence-based clinical protocols and to collect, manage and analyse data to track performance for quality assurance and improvement purposes. The JADE Program incorporates validated risk equations developed by the CUHK Diabetes Care & Research Group to stratify patients into various risk clusters for recommendation into different care protocols. This information can be relayed to people with diabetes in an interactive manner, in the form of charts and time trends, to motivate changes in behaviour and to attain treatment targets.

In this implementation project, we aim to recruit 600 type 2 diabetic patients managed in a community setting. With written informed consent, these patients will be invited to enrol into the JADE Program. After the comprehensive assessment at enrolment, half of the patients will be managed according to the JADE protocol implemented with assistance of a clinic nurse. The other half of the patients will be managed in the usual manner. At the end of 1 year, all patients will undergo repeat comprehensive assessments for comparison of attainment of treatment targets The acceptability of the JADE Program by patients and clinic staff will also be evaluated.

  Eligibility

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

Inclusion Criteria:

  1. Patients with confirmed diagnosis of type 2 diabetes, aged 18 years or above, attending the Hospital Authority Ma On Shan Family Medicine Clinic in New Territory East Cluster

  2. Type 2 diabetes is defined as follows:

    • Known history of type 2 diabetes with treatment such as lifestyle modification and/or anti-diabetic drugs for 6 months or more.

    • WHO diagnostic criteria (2 abnormal results in asymptomatic subjects or 1 abnormal result in subjects with symptoms or diabetic complications:

      • Fasting plasma glucose (PG) 7.0 mmol/L or above
      • Random PG 11.1 mmol/L or above
      • Post 75 g oral glucose tolerance test (OGTT) 2-hour PG 11.1 mmol/L or above

Exclusion Criteria:

Type 1 diabetes defined as history of ketosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or heavy ketonuria (>3+) or continuous requirement of insulin treatment within one year of diagnosis and thereafter.

  1. Patients with terminal malignancy or other life-threatening diseases with less than 6-month expected survival
  2. Telephone contact not available
  3. Patients with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711152

Contacts
Contact: Gary TC Ko, MD, FRCPI 852-26461397 garyko@cuhk.edu.hk
Contact: Juliana CN Chan, MD, FRCP 852-26323138 jchan@cuhk.edu.hk

Locations
China, /
Asia Diabetes Foundation Recruiting
Hong Kong, /, China, /
Contact: Gary TC Ko, MD, FRCPI     852-26461397     garyko@cuhk.edu.hk    
Principal Investigator: Wing-Yee So, MBChB            
Sponsors and Collaborators
Chinese University of Hong Kong
Asia Diabetes Foundation
  More Information

Additional Information:
Works of the Asia Diabetes Foundation  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Juliana Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00711152     History of Changes
Other Study ID Numbers: CRE-2007-339
Study First Received: July 7, 2008
Last Updated: January 6, 2011
Health Authority: Asia Diabetes Foundation: Hong Kong

Keywords provided by Chinese University of Hong Kong:
diabetes
protocol-driven structured care
web-based
joint asia diabetes evaluation

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

ClinicalTrials.gov processed this record on May 19, 2013