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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control; Other: Usual diabetes care alone

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.

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 10000
    • Hanoi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Intervention; The intervention of group education on type 2 diabetes, including, in addition to usual diabetes care	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
OTHER: Control; Patients meeting the inclusion criteria assigned to usual diabetes care alone	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Publications and helpful links

General Publications

• Thanh HTK, Tien TM. Effect of Group Patient Education on Glycemic Control Among People Living with Type 2 Diabetes in Vietnam: A Randomized Controlled Single-Center Trial. Diabetes Ther. 2021 May;12(5):1503-1521. doi: 10.1007/s13300-021-01052-8. Epub 2021 Apr 11.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): July 30, 2018
• Study Completion (ACTUAL): July 30, 2018

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 diabetes; education; glycemic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HMU16227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No