NCT05202470

Brief Summary

Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

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

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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 6, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

January 9, 2022

Last Update Submit

June 13, 2023

Conditions

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

  • International Survey of Physical Activity (IPAQ)

    Physical activity assessment

    4 weeks

  • Goal orientation in exercise measure (GOEM)

    Measurement of goal orientation in exercise

    4 weeks

  • Mini Nutritional Assessment

    To evaluate the nutrition status of the patients

    4 weeks

  • The Problem Areas in Diabetes Scale (PADS)

    PADS evaluates comprehensive diabetes evaluation. A total score is ranged between 0 - 100. Patients scoring 40 or higher may be at the level of "emotional burnout" and warrant special attention.

    4 weeks

Study Arms (2)

Telehealth Education (TE)

EXPERIMENTAL

After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.

Other: TE

Conventional Education (CE)

ACTIVE COMPARATOR

Paper-based education forms will be given to the patients in the first group. Face-to-face conventional diabetes education will be carried out.

Other: CE

Interventions

TEOTHER

After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.

Telehealth Education (TE)
CEOTHER

After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.

Conventional Education (CE)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a diagnosis of type 2 diabetes mellitus for at least 6 months,
  • Those between the ages of 18-65,
  • Receiving oral antidiabetic and/or insulin therapy,
  • Having a mobile phone capable of receiving and playing video messages,
  • Does not have hearing, speech and psychiatric problems that prevent communication,

You may not qualify if:

  • Individuals who do not volunteered to participate in the study
  • Patients who have hearing, speech and psychiatric problems that prevent communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Serap Tuna, PhD

    Muğla Sıtkı Koçman University

    STUDY CHAIR
  • Emine Neşe Yeniçeri, MD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR
  • Cem Şahin, MD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 21, 2022

Study Start

January 6, 2022

Primary Completion

May 10, 2023

Study Completion

May 15, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations