Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01360697
Status:
UNKNOWN
Last Update Posted:
2015-08-03
First Post:
2011-05-24
Brief Title:
An Evaluation of the Effectiveness and Acceptability of Delivering Structured Care in Chinese Type 2 Diabetic Patients
Sponsor:
Asia Diabetes Foundation
Organization:
Asia Diabetes Foundation
Study Overview
Official Title:
A Multi-Centre Demonstration Project to Evaluate the Effectiveness and Acceptability of the Joint Asia Diabetes Evaluation JADE in Chinese Type 2 Diabetic Patients in Jiangsu and Anhui JA China
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JADE-JA
Brief Summary:
In this demonstration project JADE in Jiangsu Anhui Program JADE-JA in short led by key opinion leaders in the field of diabetes and endocrinology in Jiangsu and Anhui area and supported by the ADF shall recruit 4800 type 2 diabetic patients attending medical out-patient clinics in the area to compare the effects of usual versus structured care non-JADE vs JADE on metabolic control quality of life and behavioral changes After explanation by trained doctors and nurses and with written informed consent patients will be randomized to either the JADE or non-JADE group The former encompasses all components of the structured care delivered by a trio-team of doctor nurse and Healthcare Assistant HCA while the non-JADE group only consists of comprehensive assessments CA at baseline and 12-month with patients managed in the usual manner thereafter At the end of 12 months all patients will undergo repeat comprehensive assessments for comparison of rates of attainment of treatment targets behavioral changes quality of life and default rates The acceptability of the JADE-JA Program by patients and the trio-team will also be evaluated
The investigators hypothesize that the use of state of the art information technology to record manage and analyze the large amount of clinical information generated during various consultation visits will improve the effectiveness and efficiency in implementing these care protocols through decision support and regular feedback to both patients and care team
The investigators hypothesize that the use of state of the art information technology to record manage and analyze the large amount of clinical information generated during various consultation visits will improve the effectiveness and efficiency in implementing these care protocols through decision support and regular feedback to both patients and care team
Detailed Description:
In 2007 supported by an educational grant a charitable organization named the Asia Diabetes Foundation ADF wwwadforghk was established to develop the Joint Asia Diabetes Evaluation JADE Program which comprises a web-based disease management program to enable doctors nurses and other care personnel to manage people with diabetes in an integrated and effective manner The JADE electronic portal e portal provides a virtual platform to facilitate implementation of evidence-based clinical protocols with ongoing data collection management and analysis to track performance for quality assurance and improvement purposes The JADE Program also incorporates validated risk equations developed by the Chinese University of Hong Kong CUHK Diabetes Care Research Group to stratify patients into various risk levels for recommendation of triage into different care protocols with decision supports This clinical information presented in the forms of charts and time trends can be communicated to patients and care providers to motivate behavioral changes set treatment goals and attain targets
By participating in the JADE Program the doctors will be able to create their own diabetes registry to benchmark their performance including adherence to procedures recall of default patients and rate of attainment of treatment targets In this regard the implementation of the full JADE Program requires changes in the practice environment and deployment of additional manpower eg a nurse and a HCA to enter data and provide reminders to patients and doctors to improve adherence to protocols
It is anticipated that the cost-effectiveness of the structured JADE group versus usual non-JADE group care on rates of attainment of multiple treatment targets which will translate into clinical outcomes in the long term will eventually change practice and policy to make quality diabetes care more affordable sustainable and accessible in China
In this 1-year multi-centre randomized study the investigators shall use a web-based disease management program JADE e portal to facilitate implementation of structured care with the following objectives
To evaluate the reach adoption and acceptability of the JADE e portal by patients and health care team
To compare the effectiveness of the JADE versus non-JADE Program in attainment of treatment targets improvement of quality of life and changes in behaviours
To document the pattern of complications risk factors use of medications and quality of life in type 2 diabetic patients in Jiangsu and Anhui China
By participating in the JADE Program the doctors will be able to create their own diabetes registry to benchmark their performance including adherence to procedures recall of default patients and rate of attainment of treatment targets In this regard the implementation of the full JADE Program requires changes in the practice environment and deployment of additional manpower eg a nurse and a HCA to enter data and provide reminders to patients and doctors to improve adherence to protocols
It is anticipated that the cost-effectiveness of the structured JADE group versus usual non-JADE group care on rates of attainment of multiple treatment targets which will translate into clinical outcomes in the long term will eventually change practice and policy to make quality diabetes care more affordable sustainable and accessible in China
In this 1-year multi-centre randomized study the investigators shall use a web-based disease management program JADE e portal to facilitate implementation of structured care with the following objectives
To evaluate the reach adoption and acceptability of the JADE e portal by patients and health care team
To compare the effectiveness of the JADE versus non-JADE Program in attainment of treatment targets improvement of quality of life and changes in behaviours
To document the pattern of complications risk factors use of medications and quality of life in type 2 diabetic patients in Jiangsu and Anhui China
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None