- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711152
Community Health Worker Reduces Care Utilization (JADE-MOS)
Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)
- To recruit 600 type 2 diabetic patients managed in a community setting.
- To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.
- All patients will undergo annual comprehensive assessment (CA) at a diabetes centre with personalized JADE report (JADE) at basline. Half of the randomized patients will be managed with additional support by a trained community health worker (CHW) (JADE+CHW).
- All patients will undergo annual comprehensive assessments for comparison of attainment of treatment targets for 3 years
Study Overview
Status
Conditions
Intervention / Treatment
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. All patients will undergo annual comprehensive assessment (CA) at a diabetes centre with personalized JADE report (JADE) for 3 years. Half of the patients will be managed according to the JADE protocol implemented with additional support by a trained CHW (JADE+CHW). Guided by the personalized report with embedded decision support, the CHW will reinforce treatment adherence and self care after each clinic visit.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- Asia Diabetes Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JADE with CHW
Patients will be enrolled into JADE program and will undergo annual comprehensive assessment (CA) with personalized JADE report with additional support by the CHW.
|
The JADE Program uses the state of the art of information technology to facilitate evidence-based clinical protocol by a multidisciplinary team.
There is an internet on-line and computer record system to facilitate the day-to-day management of people with diabetes.
Patients will receive additional support by a trained community health worker (CHW).
Guided by the personalized report with embedded decision support, the CHW will reinforce treatment adherence and self care after each clinic visit.
|
Active Comparator: JADE only
Patients will be enrolled into JADE program and undergo annual comprehensive assessment (CA) with personalized JADE report without additional support by the CHW.
|
The JADE Program uses the state of the art of information technology to facilitate evidence-based clinical protocol by a multidisciplinary team.
There is an internet on-line and computer record system to facilitate the day-to-day management of people with diabetes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in glycated hemoglobin level
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardio-metabolic control
Time Frame: 3 years
|
3 years
|
Number of emergency visits
Time Frame: 3 years
|
3 years
|
Hospitalizations with total length of stay
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2007-339
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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