Type 2 DiabetesNCT04403841
Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam
A study testing Usual diabetes care alone in people with Type 2 Diabetes, run by Hanoi Medical University at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Usual diabetes care alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2017to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control, Usual diabetes care alone
- Keywords
- Type 2 diabetes, education, glycemic
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose controlOther
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 aloneOther
Usual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The intervention of group education on type 2 diabetes, including, in addition to usual diabetes care Receives: 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 Receives: Other: Usual diabetes care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Aug 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Thi Kim Thanh, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403841
- Sponsor's protocol ID
- HMU16227
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33840068
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04403841
- Acronym / sponsor ID
- HMU16227
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, education, glycemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose controlThe intervention of group education on type 2 diabetes, including, in addition to usual diabetes care |
| Control | Other | Other: Usual diabetes care alonePatients meeting the inclusion criteria assigned to usual diabetes care alone |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose controlThe intervention consisted group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence | Other | Intervention |
| Usual diabetes care aloneUsual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment | Other | Control |
Primary outcome
Disease awareness
Time frame: 3-month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 33840068Thanh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual diabetes care alone in people with Type 2 Diabetes, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease awareness (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.