- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05007197
Learning Modality in Individuals With Diabetes Incompatible
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kahramanmaraş
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Pazarcik, Kahramanmaraş, Turkey, (054) 231-0182
- Kardaş Kin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
*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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention Group
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. |
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. |
|
NO_INTERVENTION: Control Group
The learning modality of the control group were determined and standard group training was provided with the education booklet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
Physiological parameter
Time Frame: 6 months
|
Change in metabolic targets (BMI, FBG, PBG, HDL, LDL, BP)
|
6 months
|
|
Effectiveness of education
Time Frame: 6 months
|
The effect of diabetes education based on learning styles will be evaluated.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ozlem KARDAS KIN, Ege University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123456789123456789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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