NCT05007197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 4, 2021

Last Update Submit

August 10, 2021

Conditions

Keywords

Diabetes EducationLearning StyleCompliance With TreatmentMetabolic Target

Outcome Measures

Primary Outcomes (3)

  • Adherence to treatment

    At the end of the education, the change in the individual's compliance with the treatment will be observed.

    6 months

  • Physiological parameter

    Change in metabolic targets (BMI, FBG, PBG, HDL, LDL, BP)

    6 months

  • Effectiveness of education

    The effect of diabetes education based on learning styles will be evaluated.

    6 months

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \*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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kardaş Kin

Pazarcık, Kahramanmaraş, (054) 231-0182, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Patient Compliance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ozlem KARDAS KIN

    Ege UNİVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 16, 2021

Study Start

January 1, 2021

Primary Completion

May 15, 2021

Study Completion

August 28, 2021

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations