The Joint Asia Diabetes Evaluation (JADE) Program in Hong Kong Community - Full Text View

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00711152

Purpose

To recruit 600 type 2 diabetic patients managed in a community setting.
To enrol into the Joint Asia Diabetes Evaluation (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.

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

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes

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: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

effectiveness and user-acceptability of the internet on-line and computer record system (JADE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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:

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
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.

Patients with terminal malignancy or other life-threatening diseases with less than 6-month expected survival
Telephone contact not available
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

Locations

China, /
Asia Diabetes Foundation
Hong Kong, /, China, /

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

No publications provided

Responsible Party:	Chinese University of Hong Kong ( Juliana Chan )
Study ID Numbers:	CRE-2007-339
Study First Received:	July 7, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00711152 History of Changes
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:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009