Type 2 DiabetesNCT04677127
Effect of HBM Based Education on Glycemic Control of Type 2 Diabates Patients
A study testing Health Belief Model and Health Literacy Level based Education and Counseling in people with Type 2 Diabetes, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Health Belief Model and Health Literacy Level based Education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2019to 2 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 Diabates Mellitus at least for a year
- Literate
Who cannot join
- Problems with vision and hearing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Health Belief Model and Health Literacy Level Based Education and Counseling on Glycemic Control in Type 2 Diabetes Patients
This pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. Study was carried out in Isparta Davraz Family Health Centre between June 17, 2019 and March 02, 2020. Sample consisted of 120 patients with type 2 diabetes, selected by simple randomization method, including 60 patients for the intervention group and 60 patients for the control group.
Patients in intervention and control were also sub-grouped according to their health literacy level. The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. "Patient Data Form", "Health Literacy Scale Among Diabetes Patients", "Health Belief Model Scale in Diabetes Patients" and "Type 2 Diabetes Self-Efficacy Scale" used for data collection. Data were collected both on the first day of the study and in the 24th week.
- Conditions
- Type 2 Diabetes
- Being tested
- Health Belief Model and Health Literacy Level based Education and Counseling
- 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.
Health Belief Model and Health Literacy Level based Education and CounselingBehavioural
Patients given education and counseling constructed with health belief model (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cue to action, self-efficacy). The constructed education given through groups dichotomised by health literacy levels (low/high). Groups of 11-13, had weekly educations for 6 weeks, 6 weeks of counselling and 12 week of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. Receives: Behavioral: Health Belief Model and Health Literacy Level based Education and Counseling |
| Control | No intervention | Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control Change
HbA1C-Change from Baseline HbA1C at 6 months
Measured: pre-test (week 1), post-test (week 24)
Secondary outcomes (2)
Health Belief Model Questionnaire
Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores
Measured: pre-test (week 1), post-test (week 24)
Self-Efficacy Questionnaire
Change from Baseline self-efficacy level scores at 6 months
Measured: pre-test (week 1), post-test (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start17 Jun 2019
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İmatullah Akyar, Hacettepe University
- Investigators
- İmatullah Akyar, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677127
- Sponsor's protocol ID
- 16969557-1072
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrali H, Akyar I. The effect of health literacy-based, health belief-constructed education on glycated hemoglobin (HbA1c) in people with type 2 diabetes: A randomized controlled study. Prim Care Diabetes. 2022 Feb;16(1):173-178. doi: 10.1016/j.pcd.2021.12.010. Epub 2021 Dec 31.
PubMed 34980562
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model and Health Literacy Level Based Education and Counseling on Glycemic Control in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT04677127
- Acronym / sponsor ID
- 16969557-1072
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 21 Dec 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 pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. Study was carried out in Isparta Davraz Family Health Centre between June 17, 2019 and March 02, 2020. Sample consisted of 120 patients with type 2 diabetes, selected by simple randomization method, including 60 patients for the intervention group and 60 patients for the control group.
Patients in intervention and control were also sub-grouped according to their health literacy level. The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. "Patient Data Form", "Health Literacy Scale Among Diabetes Patients", "Health Belief Model Scale in Diabetes Patients" and "Type 2 Diabetes Self-Efficacy Scale" used for data collection. Data were collected both on the first day of the study and in the 24th week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health Belief Model and Health Literacy Level based Education and CounselingThe intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. |
| Control | No intervention | –Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of type 2 Diabates Mellitus at least for a year
- Literate
Key exclusion criteria (1 listed)
- Problems with vision and hearing
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 |
|---|---|---|
| Health Belief Model and Health Literacy Level based Education and CounselingPatients given education and counseling constructed with health belief model (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cue to action, self-efficacy). The constructed education given through groups dichotomised by health literacy levels (low/high). Groups of 11-13, had weekly educations for 6 weeks, 6 weeks of counselling and 12 week of follow-up. | Behavioural | Intervention |
Primary outcome
Glycemic Control Change
Time frame: pre-test (week 1), post-test (week 24)
HbA1C-Change from Baseline HbA1C at 6 months
2 secondary outcomes
Health Belief Model Questionnaire
Time frame: pre-test (week 1), post-test (week 24)
Self-Efficacy Questionnaire
Time frame: pre-test (week 1), post-test (week 24)
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 21 Dec 2020.
- Derived from this study: PubMed 34980562Agrali H, Akyar I. The effect of health literacy-based, health belief-constructed education on glycated hemoglobin (HbA1c) in people with type 2 diabetes: A randomized controlled study. Prim Care Diabetes. 2022 Feb;16(1):173-178. doi: 10.1016/j.pcd.2021.12.010. Epub 2021 Dec 31.
- 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.
İmatullah Akyar principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model and Health Literacy Level based Education and Counseling in people with Type 2 Diabetes, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 21 Dec 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 Turkey (Türkiye). 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?
Glycemic Control Change (time frame: pre-test (week 1), post-test (week 24)). 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 NCT04677127, 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 21 Dec 2020.