Type 2 Diabetes MellitusPhase 4JADE-MOSNCT00711152
Community Health Worker Reduces Care Utilization
A Phase 4 study testing Protocol-driven care under JADE Program and Additional support by CHW in people with Type 2 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Protocol-driven care under JADE Program and Additional support by CHW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2008to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)
- To recruit 600 type 2 diabetic patients managed in a community setting.
- To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.
- 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).
- All patients will undergo annual comprehensive assessments for comparison of attainment of treatment targets for 3 years
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Protocol-driven care under JADE Program, Additional support by CHW
- Keywords
- diabetes, protocol-driven structured care, web-based, joint asia diabetes evaluation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Protocol-driven care under JADE Program; Other: 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. Receives: Other: Protocol-driven care under JADE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin level
Measured: 3 years
Secondary outcomes (3)
Cardio-metabolic control
Measured: 3 years
Number of emergency visits
Measured: 3 years
Hospitalizations with total length of stay
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Asia Diabetes Foundation
- Responsible party
- Principal investigator, Juliana Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711152
- Sponsor's protocol ID
- CRE-2007-339
- Acronym
- JADE-MOS
- Status last verified
- Sep 2015
- First submitted
- 7 Jul 2008
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)
- ClinicalTrials.gov ID
- NCT00711152
- Acronym / sponsor ID
- JADE-MOS / CRE-2007-339
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, protocol-driven structured care, web-based, joint asia diabetes evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Asia Diabetes Foundation
- Study start
- Feb 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To recruit 600 type 2 diabetic patients managed in a community setting.
- To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.
- 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).
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JADE with CHW | Experimental | Other: Protocol-driven care under JADE Program, Other: Additional support by CHWPatients will be enrolled into JADE program and will undergo annual comprehensive assessment (CA) with personalized JADE report with additional support by the CHW. |
| JADE only | Active comparator | Other: Protocol-driven care under JADE ProgramPatients will be enrolled into JADE program and undergo annual comprehensive assessment (CA) with personalized JADE report without additional support by the CHW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol-driven care under JADE ProgramThe 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 | JADE only, JADE with CHW |
| Additional support by CHWPatients 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. | Other | JADE with CHW |
Primary outcome
Change in glycated hemoglobin level
Time frame: 3 years
3 secondary outcomes
Cardio-metabolic control
Time frame: 3 years
Number of emergency visits
Time frame: 3 years
Hospitalizations with total length of stay
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Works of the Asia Diabetes FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Protocol-driven care under JADE Program and Additional support by CHW in people with Type 2 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin level (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.