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

H

Hanoi Medical University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Other: Usual diabetes care alone
Other: patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control

Study type

Interventional

Funder types

Other

Identifiers

NCT04403841
HMU16227

Details and patient eligibility

About

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.

Full 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.

Enrollment

405 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

405 participants in 2 patient groups

Intervention
Other group
Description:
The intervention of group education on type 2 diabetes, including, in addition to usual diabetes care
Treatment:
Other: patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control
Control
Other group
Description:
Patients meeting the inclusion criteria assigned to usual diabetes care alone
Treatment:
Other: Usual diabetes care alone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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