NCT01360697

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,800

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

8 active sites

Status
unknown

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

May 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

4.6 years

First QC Date

May 24, 2011

Last Update Submit

July 31, 2015

Conditions

Diabetes

Keywords

DiabetesStructured care

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who attain 2 or more of the 'ABC'targets

    Percentage of patients who attain 2 or more of the following 3 targets: 1. HbA1c \<7% 2. BP \<130/80 mmHg 3. LDL cholesterol \<2.6 mmol/L

    12 months

Secondary Outcomes (6)

  • New onset of all diabetes-related endpoints

    12 months

  • Quality of Life

    12 Months

  • Behavioral changes (in the last 3 months)

    12 months

  • Frequency of hypoglycaemia (in the last 3 months)

    12 months

  • Number of hospitalizations, follow up visits by doctors and other care professionals during the 12 months

    12 months

  • +1 more secondary outcomes

Study Arms (2)

JADE- JA

EXPERIMENTAL

Use the JADE portal to monitor the delivery of structured care.

Other: JADE

Usual care

ACTIVE COMPARATOR

Patients will receive usual care in between two annual comprehensive assessments.

Other: Non-JADE

Interventions

JADEOTHER

1. The nurse will complete the CA using standardized protocol including blood \& urine tests, eye \& feet examination. 2. Whenever feasible, the nurse will arrange 2-4 hours of diabetes education in groups or on an individual basis as appropriate. 3. Between each follow-up (FU) visit, the nurse or HCA will contact the patient by phone or email to remind them to attend visits, adhere to medications \& healthy lifestyles, perform self blood glucose monitoring as appropriate. 4. At each FU visit, the patients will first see the nurse or HCA for record of blood pressure, body weight \& blood glucose (or A1c) measurement as appropriate. Compliance will also be checked using the 4-item questionnaire. 5. After the FU visit, the patients will see the nurse or HCA again to clarify any issues \& concerns, reinforce compliance \& record any changes in medications. 6. After each FU visit, the HCA will generate summary reports to be given to patients \& doctors to promote sharing of information.

JADE- JA
Non-JADEOTHER

Patients will receive a comprehensive assessments at baseline and again after 12 months. In the interim between these two time points patients will be managed according to 'usual care' procedures.

Usual care

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetic patients attending the 8 hospitals or affiliated clinics led by PIs of the JADE-JA Program who are living in the area with an intention to have 'regular' follow-up
  • Aged ≥ 18 years
  • Patients can have newly diagnosed or established disease, treated with lifestyle or blood glucose lowering drugs including oral agents with or without insulin
  • For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be:
  • Fasting plasma glucose (PG) ≥ 7.0 mmol/L on 2 or more occasions, and/or
  • Random (or post-OGTT 2h) PG ≥ 11.1 mmol/L on 2 or more occasions, and/or

You may not qualify if:

  • Type 1 diabetes defined as a history of ketosis at diagnosis \[acute symptoms with heavy ketonuria (\> 3+) or ketoacidosis\] or continuous requirement of insulin within one year of diagnosis
  • Patients with reduced life expectancy (e.g. less than 6-months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life threatening conditions
  • Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
  • Patients actively enrolled in another intervention study
  • Patients who are unwilling to return for regular follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chinese Medicine Hospital of Anhui Province

Anhui, China

Location

Third People's Hospital of Hefei City

Hefei, China

Location

HuaiAn Second People's Hospital

HuaiAn, China

Location

Jiangsu Province Official Hospital

Jiangsu, China

Location

Rehab Hosp of Zhenjiang, Jiangsu Province

Jiangsu, China

Location

The Affiliated Hosp of Jiangsu-Nantong U

Jiangsu, China

Location

First People's Hospital of Kunshan City

Kunshan, China

Location

Second Affiliated Hospital of Suzhou University

Suzhou, China

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Juliana Chan, MD

    Asia Diabetes Foundation

    PRINCIPAL INVESTIGATOR

  • Gary Ko, MD

    Asia Diabetes Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations

CN(8)