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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403841
• Other study ID #: HMU16227
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: May 2020
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• patient 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
• Usual 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

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease awareness	All 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.	3-month