Diabetes Mellitus, Type 2NCT05007197
Learning Modality in Individuals With Diabetes Incompatible
A study testing The Effect of Diabetes Education Based on Learning Modality in people with Diabetes Mellitus, Type 2, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of education based on learning styles in diabetic individuals who are incompatible with treatment, on treatment compliance and metabolic goals. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- The Effect of Diabetes Education Based on Learning Modality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 28 Aug 2021
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age range of 20-65,
- at least 6 months diagnosis,
- ability to communicate in Turkish,
- mentally stable, with no vision, verbal, or hearing impairments
- not having any obstacle to continue the implementation phase of the research (for example, pregnancy plan, change of city, etc.),
- not having advanced hearing-vision problems and another serious disease or serious complication due to diabetes (amputation, etc.)
- it is to get a score between 55 and 150 (incompatible with treatment) from the Patient Compliance Scale in Type 2 DM Treatment.
Who cannot join
- He/she received training on recurrent diabetes at Dokuz Eylul University Hospital.
- to be,
- The patient's perception disorder and psychiatric disorder that prevent communication to be found,
- Having been diagnosed with cancer,
- Being pregnant,
- Blind retinopathy, advanced neuropathy and foot wound
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kardaş Kin
Pazarcık, Kahramanmaraş, (054) 231-0182
About this study
Official title: The Effect of Diabetes Education Based on Learning Modality in Individuals With Diabetes Incompatible With Treatment on Compliance and Metabolic Goals: A Randomized Controlled Trial
This study was planned to examine the effect of education based on learning styles in diabetic individuals who are incompatible with treatment, on treatment compliance and metabolic goals. The study was conducted as a randomized controlled study between January-September 2021 in Dokuz Eylül University Training and Research Hospital Endocrinology and Metabolic Diseases Polyclinic and Internal Medicine Polyclinic.
Read the detailed description
Among the individuals who applied to the outpatient clinic and were eligible for inclusion in the study, the odd numbers were assigned to the application group, and the even numbers to the control group.
The practice group of 30 people and the control group were divided into 3 groups as auditory (n: 10), visual (n: 10) and physical learners (n: 10). Research data; The Individual Identification Form was collected using the Patient Compliance Scale for Type 2 DM Treatment, the BIG 16 Learning Styles Inventory, the Standardized Mini Mental Test (SMMT) and the Metabolic Goal Control Form. The training group was given according to the learning styles. The auditory group in the post-training practice group; calling by phone, to the visual group; By SMS, to the physical group; reminder alerts were made by phone + SMS. Standard training was given to the control group. Metabolic target values of the application and control groups were examined at 3 and 6 months after the training.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- The Effect of Diabetes Education Based on Learning Modality
- Keywords
- Diabetes Education, Learning Style, Compliance With Treatment, Metabolic Target
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Diabetes Education Based on Learning ModalityBehavioural
After controlling the metabolic values of the individuals in the intervention group, the education were carried out according to the learning modality of the people; Visual learners; education booklet, brochure, slides (enriched with pictures and videos), lecture, insulin injector-pen, glucose meters, introduction and demonstration of blood glucose tracking book Auditory learners; education booklet, slides, videos, lecture, question-answer, group work, peer group discussion, experience sharing Tactile learners; education booklet, slides, demonstration, insulin injector-pen, glucose meter doing the application of tools and equipment such as on the model, on himself, on his friend, filling in the blood glucose tracking book.
Group-specific diabetes trainings were completed in 2 training sessions. Each training session lasted an average of 1.5 hours The learning modality of the control group were determined and standard group training was provided with the education booklet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After controlling the metabolic values of the individuals in the intervention group, the education were carried out according to the learning modality of the people.
Group-specific diabetes trainings were completed in two training sessions. Each training session lasted an average of one and a half hours and a fifteen minute break was given.
The auditory group in the intervention group, calling by phone; visual group by SMS and WhatsApp tactile group, reminder alerts were made by phone+SMS+WhatsApp. Receives: Behavioral: The Effect of Diabetes Education Based on Learning Modality |
| Control Group | No intervention | The learning modality of the control group were determined and standard group training was provided with the education booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment
At the end of the education, the change in the individual's compliance with the treatment will be observed.
Measured: 6 months
Physiological parameter
Change in metabolic targets (BMI, FBG, PBG, HDL, LDL, BP)
Measured: 6 months
Effectiveness of education
The effect of diabetes education based on learning styles will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jan 2021
- Primary completion15 May 2021
- Study completion28 Aug 2021 (estimated)
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 Diabetes Mellitus, Type 2Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Among the individuals who applied to the outpatient clinic and were eligible for inclusion in the study, the odd numbers were assigned to the application group, and the even numbers to the control group. The practice group of 30 people and the control group were divided into 3 groups as auditory (n: 10), visual (n: 10) and physical learners (n: 10).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem KARDAŞ KİN, Ege University
- Investigators
- Ozlem KARDAS KIN, Principal investigator, Ege UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007197
- Sponsor's protocol ID
- 123456789123456789
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kardas Kin O, Tureyen A. The effect of diabetes education based on learning modality in individuals with diabetes incompatible with treatment on compliance and metabolic goals: A randomized controlled trial. Prim Care Diabetes. 2022 Feb;16(1):150-155. doi: 10.1016/j.pcd.2021.12.006. Epub 2021 Dec 18.
PubMed 34930689
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetes Education Based on Learning Modality in Individuals With Diabetes Incompatible With Treatment on Compliance and Metabolic Goals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05007197
- Acronym / sponsor ID
- 123456789123456789
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Education, Learning Style, Compliance With Treatment, Metabolic Target
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 28 Aug 2021 (estimated)
- First posted
- 16 Aug 2021 (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 was planned to examine the effect of education based on learning styles in diabetic individuals who are incompatible with treatment, on treatment compliance and metabolic goals. The study was conducted as a randomized controlled study between January-September 2021 in Dokuz Eylül University Training and Research Hospital Endocrinology and Metabolic Diseases Polyclinic and Internal Medicine Polyclinic.
Detailed description
Among the individuals who applied to the outpatient clinic and were eligible for inclusion in the study, the odd numbers were assigned to the application group, and the even numbers to the control group.
The practice group of 30 people and the control group were divided into 3 groups as auditory (n: 10), visual (n: 10) and physical learners (n: 10). Research data; The Individual Identification Form was collected using the Patient Compliance Scale for Type 2 DM Treatment, the BIG 16 Learning Styles Inventory, the Standardized Mini Mental Test (SMMT) and the Metabolic Goal Control Form. The training group was given according to the learning styles. The auditory group in the post-training practice group; calling by phone, to the visual group; By SMS, to the physical group; reminder alerts were made by phone + SMS. Standard training was given to the control group. Metabolic target values of the application and control groups were examined at 3 and 6 months after the training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Among the individuals who applied to the outpatient clinic and were eligible for inclusion in the study, the odd numbers were assigned to the application group, and the even numbers to the control group. The practice group of 30 people and the control group were divided into 3 groups as auditory (n: 10), visual (n: 10) and physical learners (n: 10).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: The Effect of Diabetes Education Based on Learning ModalityAfter controlling the metabolic values of the individuals in the intervention group, the education were carried out according to the learning modality of the people. Group-specific diabetes trainings were completed in two training sessions. Each training session lasted an average of one and a half hours and a fifteen minute break was given. The auditory group in the intervention group, calling by phone; visual group by SMS and WhatsApp tactile group, reminder alerts were made by phone+SMS+WhatsApp. |
| Control Group | No intervention | –The learning modality of the control group were determined and standard group training was provided with the education booklet. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age range of 20-65,
- at least 6 months diagnosis,
- ability to communicate in Turkish,
- mentally stable, with no vision, verbal, or hearing impairments
- not having any obstacle to continue the implementation phase of the research (for example, pregnancy plan, change of city, etc.),
Key exclusion criteria (6 listed)
- He/she received training on recurrent diabetes at Dokuz Eylul University Hospital.
- to be,
- The patient's perception disorder and psychiatric disorder that prevent communication to be found,
- Having been diagnosed with cancer,
- Being pregnant,
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 |
|---|---|---|
| The Effect of Diabetes Education Based on Learning ModalityAfter controlling the metabolic values of the individuals in the intervention group, the education were carried out according to the learning modality of the people; Visual learners; education booklet, brochure, slides (enriched with pictures and videos), lecture, insulin injector-pen, glucose meters, introduction and demonstration of blood glucose tracking book Auditory learners; education booklet, slides, videos, lecture, question-answer, group work, peer group discussion, experience sharing Tactile learners; education booklet, slides, demonstration, insulin injector-pen, glucose meter doing the application of tools and equipment such as on the model, on himself, on his friend, filling in the blood glucose tracking book. Group-specific diabetes trainings were completed in 2 training sessions. Each training session lasted an average of 1.5 hours The learning modality of the control group were determined and standard group training was provided with the education booklet. | Behavioural | Intervention Group |
Primary outcome
Adherence to treatment
Time frame: 6 months
At the end of the education, the change in the individual's compliance with the treatment will be observed.
Physiological parameter
Time frame: 6 months
Change in metabolic targets (BMI, FBG, PBG, HDL, LDL, BP)
Effectiveness of education
Time frame: 6 months
The effect of diabetes education based on learning styles will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 34930689Kardas Kin O, Tureyen A. The effect of diabetes education based on learning modality in individuals with diabetes incompatible with treatment on compliance and metabolic goals: A randomized controlled trial. Prim Care Diabetes. 2022 Feb;16(1):150-155. doi: 10.1016/j.pcd.2021.12.006. Epub 2021 Dec 18.
- 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.
Ozlem KARDAS KIN principal investigator
Ege UNİVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Diabetes Education Based on Learning Modality in people with Diabetes Mellitus, Type 2, run by Ege 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Aug 2021. 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?
Results are not available in the source record.
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?
Adherence to treatment (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05007197, 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 16 Aug 2021.