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

NCT04403841 | Completed

• 1 other identifier: HMU16227
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; education; glycemic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

OTHER

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

Control

OTHER

Patients meeting the inclusion criteria assigned to usual diabetes care alone

Other: Usual diabetes care alone

Interventions

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

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

Intervention

Usual diabetes care alone OTHER

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

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, 10000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 33840068 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 27, 2020
• Study Start: August 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)