NCT00711152

Brief Summary

  1. 1.To recruit 600 type 2 diabetic patients managed in a community setting.
  2. 2.To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.
  3. 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. 4.All patients will undergo annual comprehensive assessments for comparison of attainment of treatment targets for 3 years

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
661

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

6.1 years

First QC Date

July 7, 2008

Last Update Submit

September 5, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesprotocol-driven structured careweb-basedjoint asia diabetes evaluation

Outcome Measures

Primary Outcomes (1)

  • Change in glycated hemoglobin level

    3 years

Secondary Outcomes (3)

  • Cardio-metabolic control

    3 years

  • Number of emergency visits

    3 years

  • Hospitalizations with total length of stay

    3 years

Study Arms (2)

JADE with CHW

EXPERIMENTAL

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 ProgramOther: Additional support by CHW

JADE only

ACTIVE COMPARATOR

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

Interventions

Protocol-driven care under JADE ProgramOTHER

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.

JADE onlyJADE with CHW
Additional support by CHWOTHER

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.

JADE with CHW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia Diabetes Foundation

Hong Kong, Hong Kong

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor of Medicine and Therapeutics

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 8, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

HK(1)