Community Health Worker Reduces Care Utilization

Type 2 Diabetes Mellitus Clinical Trial

— JADE-MOS  

Official title:

Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711152
• Other study ID #: CRE-2007-339
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2008
• Last updated: September 5, 2015
• Start date: February 2008
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Asia Diabetes Foundation
• Study type: Interventional

Clinical Trial Summary

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. 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).

4. All patients will undergo annual comprehensive assessments for comparison of attainment of treatment targets for 3 years

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Protocol-driven care under JADE Program
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.
• Additional support by CHW
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.

Locations

Country	Name	City	State
Hong Kong	Asia Diabetes Foundation	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Asia Diabetes Foundation

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated hemoglobin level		3 years	No
Secondary	Cardio-metabolic control		3 years	No
Secondary	Number of emergency visits		3 years	No
Secondary	Hospitalizations with total length of stay		3 years	No

External Links

•   Works of the Asia Diabetes Foundation