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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 7, 2008 |
| Last Updated Date | January 28, 2009 |
| Start Date ICMJE | March 2008 |
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Change in glycated hemoglobin level [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00711152 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
effectiveness and user-acceptability of the internet on-line and computer record system (JADE) [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | The Joint Asia Diabetes Evaluation (JADE) Program in Hong Kong Community |
| Official Title ICMJE | 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 |
| Brief Summary |
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| 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. |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Other, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Type 2 Diabetes Mellitus |
| Intervention ICMJE | Other: Protocol-driven care under JADE Program |
| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 600 |
| Estimated Completion Date | November 2011 |
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
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.
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | China |
| Administrative Information | |
| NCT ID ICMJE | NCT00711152 |
| Responsible Party | Juliana Chan, Chinese University of Hong Kong |
| Study ID Numbers ICMJE | CRE-2007-339 |
| Study Sponsor ICMJE | Chinese University of Hong Kong |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Chinese University of Hong Kong |
| Verification Date | January 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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