An Evaluation of the Effectiveness and Acceptability of Delivering Structured Care in Chinese Type 2 Diabetic Patients

NCT01360697 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4800

Last updated 2015-08-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

JADE

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.

OTHER

Non-JADE

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.

Sponsors & Collaborators

  • Asia Diabetes Foundation

    lead OTHER

Principal Investigators

  • Juliana Chan, MD · Asia Diabetes Foundation

  • Gary Ko, MD · Asia Diabetes Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360697 on ClinicalTrials.gov