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Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam

Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04403841
Enrollment
405
Registered
2020-05-27
Start date
2017-08-01
Completion date
2018-07-30
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes, education, glycemic

Brief summary

This study measures the effect of a 3-month patient education and self-management intervention in a low-resource setting, on diabetes knowledge and levels of blood glucose control.

Detailed description

In Vietnam, there is a low level of diabetes knowledge among the general population, and significantly lower awareness in rural areas compared with urban areas. This highlights the urgent need for communication and education to improve the knowledge of the Vietnamese population of patients with type 2 diabetes on risk factors, complications, prevention and treatment. The main goal of this study is to evaluate the effects of a patient education and self-management intervention as add-on to usual diabetes care in a low-resource setting on diabetes knowledge and blood glucose control parameters in Vietnamese patients with type 2 diabetes. This is a single-center, randomized, controlled study among adult out-patients with type 2 diabetes. Patients meeting the inclusion criteria are randomly assigned to a community intervention or to usual diabetes care alone (control group) for a period of 3 months. The intervention consists of group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence. Each patient should attend the group education monthly over 3 consecutive months. Usual diabetes care is consistent with the ADA guidelines and comprises standard dietary and exercise advice in addition to antidiabetes treatment. Diabetes knowledge is measured with a modified Michigan University Diabetes Knowledge Test (MDKT). Other study outcomes includes change in mean HbA1c, fasting blood glucose, and systolic blood pressure.

Interventions

OTHERpatient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control

The intervention consisted group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence

OTHERUsual diabetes care alone

Usual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment

Sponsors

Hanoi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with type 2 diabetes as defined above * Aged 40-80 years old * Ability to attend monthly clinic visits and signed informed consent * All antidiabetes treatments were permitted including insulin

Exclusion criteria

* A diagnosis of mental or neurological diseases that could interfere with the ability to comply with study procedures * Pregnancy or lactation * Known drug or alcohol dependence * Requirement for a change in antidiabetes treatment over the study period

Design outcomes

Primary

MeasureTime frameDescription
Disease awareness3-monthAll patients complete a modified Michigan University Diabetes Knowledge Test (MDKT) (16) at baseline and at the end of the 3-month trial. The MDKT is a quick and low-cost method of assessing general knowledge of diabetes and diabetes self-care. The 23-item original questionnaire was translated into Vietnamese and adapted as required based on a pilot test performed in 10 people with type 2 diabetes, which resulted in one question being removed. The modified questionnaire therefore consist of 22 statements with multiple choice answers with 1 point awarded for each correct answer (Appendix 1). Patients who answer \>50% of the questions correctly considered to pass the knowledge test, and patients who answer \<50% of the questions correctly considered to fail. The proportion of successful patients (i.e. with MDKT total score ≥11) the study primary outcome.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026