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Community Health Worker Reduces Care Utilization (JADE-MOS)

This study has been completed.
Sponsor:
Collaborator:
Asia Diabetes Foundation
Information provided by (Responsible Party):
Juliana Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00711152
First received: July 7, 2008
Last updated: September 5, 2015
Last verified: September 2015
  Purpose
  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

Condition Intervention Phase
Type 2 Diabetes Mellitus
Other: Protocol-driven care under JADE Program
Other: Additional support by CHW
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Change in glycated hemoglobin level [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardio-metabolic control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of emergency visits [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Hospitalizations with total length of stay [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 661
Study Start Date: February 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: 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.
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.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711152

Locations
Hong Kong
Asia Diabetes Foundation
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Asia Diabetes Foundation
  More Information

Additional Information:
Responsible Party: Juliana Chan, Chair Professor of Medicine and Therapeutics, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00711152     History of Changes
Other Study ID Numbers: CRE-2007-339 
Study First Received: July 7, 2008
Last Updated: September 5, 2015
Health Authority: Hong Kong: Asia Diabetes Foundation

Keywords provided by Chinese University of Hong Kong:
diabetes
protocol-driven structured care
web-based
joint asia diabetes evaluation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016