Clinical trial NCT00711152: Community Health Worker Reduces Care Utilization
Official title: Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
protocol-driven structured care
web-based
joint asia diabetes evaluation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Asia Diabetes Foundation
First posted: 2008-07-08
Enrollment: 661
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glycated hemoglobin level
timeFrame: 3 years
Secondary outcomes:
measure: Cardio-metabolic control
timeFrame: 3 years
measure: Number of emergency visits
timeFrame: 3 years
measure: Hospitalizations with total length of stay
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Asia Diabetes Foundation
Study officials:
References: