Back to resultsLearning Modality in Individuals With Diabetes Incompatible
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Effect of Diabetes Education Based on Learning Modality
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Education, Learning Style, Compliance With Treatment, Metabolic Target
Eligibility Criteria
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
Sites / Locations
- Kardaş Kin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
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.
The learning modality of the control group were determined and standard group training was provided with the education booklet.
Outcomes
Primary Outcome Measures
Adherence to treatment
At the end of the education, the change in the individual's compliance with the treatment will be observed.
Physiological parameter
Change in metabolic targets (BMI, FBG, PBG, HDL, LDL, BP)
Effectiveness of education
The effect of diabetes education based on learning styles will be evaluated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05007197
Brief Title
Learning Modality in Individuals With Diabetes Incompatible
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
August 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Education, Learning Style, Compliance With Treatment, Metabolic Target
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The learning modality of the control group were determined and standard group training was provided with the education booklet.
Intervention Type
Behavioral
Intervention Name(s)
The Effect of Diabetes Education Based on Learning Modality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to treatment
Description
At the end of the education, the change in the individual's compliance with the treatment will be observed.
Time Frame
6 months
Title
Physiological parameter
Description
Change in metabolic targets (BMI, FBG, PBG, HDL, LDL, BP)
Time Frame
6 months
Title
Effectiveness of education
Description
The effect of diabetes education based on learning styles will be evaluated.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem KARDAS KIN
Organizational Affiliation
Ege UNİVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kardaş Kin
City
Pazarcik
State/Province
Kahramanmaraş
ZIP/Postal Code
(054) 231-0182
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34930689
Citation
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.
Results Reference
derived
Learn more about this trial
Learning Modality in Individuals With Diabetes Incompatible
We'll reach out to this number within 24 hrs