Community Health Worker Reduces Care Utilization

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Protocol-driven care under JADE Program; Other: Additional support by CHW

• Registration Number: NCT00711152
• Lead Sponsor: Chinese University of Hong Kong

Brief 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

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-05
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 661

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JADE only	Protocol-driven care under JADE Program	Patients will be enrolled into JADE program and undergo annual comprehensive assessment (CA) with personalized JADE report without additional support by the CHW.
JADE with CHW	Additional support by 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.
JADE with CHW	Protocol-driven care under JADE Program	Patients will be enrolled into JADE program and will undergo annual comprehensive assessment (CA) with personalized JADE report with additional support by the CHW.

Primary Outcome Measures

Name	Time	Method
Change in glycated hemoglobin level	3 years

Secondary Outcome Measures

Name	Time	Method
Cardio-metabolic control	3 years
Number of emergency visits	3 years
Hospitalizations with total length of stay	3 years

Trial Locations

Locations (1)

Asia Diabetes Foundation; 🇭🇰 Hong Kong, Hong Kong