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The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar Level

Primary Purpose

Diabetes Mellitus, Type 2, Education, Mobile Applications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Application Supported Nutrition and Diabetes Education
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed type 2 diabetes patients in the endocrinology and metabolism outpatient clinic of Ege University Medical Faculty Hospital.
  • Patients with Type 2 DM, between the ages of 18-64, using smart phones and having regular internet will be included in the study.

Exclusion Criteria:

  • Those who receive regular messages every day will be checked, and those who do not open/read more than 25% of the messages in total will be excluded.
  • type 1 diabetes or gestational diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Study Group

    Arm Description

    After the physician involved in the study asks the participants for their biochemical tests (FBC, HbA1C, LDL-C, HDL-C, Total K, Triglyceride), the outpatient dietitian will give routine nutrition education to the participants. In addition, a data collection form including socio-demographic information, health history, nutrition history and height, weight, waist circumference measurements will be made and filled by the thesis student.

    The software developed for this research will be downloaded to the phones of the participants in the intervention group. With this software prepared, written and visual information (pictures, mini-videos) will be given to participants every day for 3 months on diabetes, self-management of diabetes and nutrition. Whether the participants read the messages or not will also be monitored through this software. At the end of 3 months, the participants in the intervention and control groups will be invited again, and their biochemical parameters and self-management status will be measured according to the diabetes self-management scale. Data will be collected through face-to-face interviews in the outpatient clinic, and weight will be measured with the bioelectrical impedance analyzer in the outpatient clinic, height will be measured with a height meter fixed to the wall, and waist circumference will be measured with a non-stretchable measuring tape.

    Outcomes

    Primary Outcome Measures

    The effect of mobile application supported diabetes education on type 2 diabetes self-management.
    Type 2 diabetes self-management scores of the participants in the study group and control group will be compared. For this comparison, the "Type 2 Diabetes Self-Management Scale" consisting of 3 sub-titles (Healthy Lifestyle Behaviors, Blood Sugar Management, Health Services Use) and 19 items developed in 2020 will be applied. (Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1 point). Those with higher scores will be considered to show better self-management. This scale will first be administered to the participants when they are diagnosed with type 2 diabetes in the hospital. Participants will be given diabetes and nutrition education for 3 months, and the Type 2 Diabetes Self-Management Scale will be repeated by inviting them to the hospital for control. Then, the participants will be taken into a 3-month follow-up process and at the end of the process, they will be invited to the hospital for control and the Type 2 Diabetes Self-Management Scale will be repeated.
    The effect of mobile application supported diabetes education on blood sugar
    The physician participating in the study will measure the Fasting Blood Sugar (mg/dl) values of the participants. When the participants are diagnosed with type 2 diabetes, their Fasting Blood Sugar (mg/dl) values will be measured and a 3-month diabetes education will be given. At the end of this diabetes training, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again. Then, the participants will be taken to the 3-month follow-up process and at the end of the process, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again. At the end of the research, the effects of mobile application supported diabetes education on fasting blood sugar (mg/dl) will be compared with the routine diabetes education given in the hospital.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 30, 2021
    Last Updated
    January 27, 2022
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05228561
    Brief Title
    The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar Level
    Official Title
    The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar In Newly Diagnosed Type 2 Diabetes Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    November 15, 2022 (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
    No

    5. Study Description

    Brief Summary
    Diabetes is one of the biggest public health problems of the 21st century. Type 2 diabetes mellitus accounts for more than 90% of all diabetes cases and is the most common type of diabetes. Type 2 diabetes, in which genetic and environmental factors play a role,It is a metabolic disorder in which insulin resistance, decrease in insulin secretion and incretin hormone deficiency are effective in its physiopathology, characterized by polydipsia, polyphagia and polyuria, where the organism cannot adequately benefit from carbohydrates, fats and proteins due to insulin deficiency or defects in the effect of insulin, which requires continuous medical care. Diabetes is a major cause of blindness, end-stage renal disease, coronary artery disease, stroke and inferior extremity amputations. These complications due to diabetes impair the patient's quality of life and impose social, financial and emotional burdens on both the patient and their family. Diabetes education should be provided by healthcare professionals in order to ensure that diabetes patients knowledge and skills to prevent complications and provide better self management and self-care. However, The fact that individuals do not have time to spare for face-to-face health education, the possibility of accessing information in the web environment repeatedly and the lower cost of education in the web environment compared to classical education increases the importance of web-based health education. The widespread use of mobile technologies in recent years has led to the development of new mobile applications related to diabetes. The disquisition proposal the investigators prepared was created to investigate the effect of mobile application supported diabetes and nutrition education on type 2 diabetes self-management and blood sugar in newly diagnosed type 2 diabetes patients. In this context, with the development of a mobile application prepared in visual, text and video format to provide diabetes education, the monitoring of blood parameters before and after diabetes education, and the implementation of the Type 2 Diabetes Self-Management Scale, (which consists of 19 items developed in 2020), and type 2 diabetes self-management and the effect on blood sugar will be examined. This study will provide answers to questions about the effectiveness of diabetes education given to Type 2 Diabetes patients via mobile applications on diabetes self-management and blood parameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Education, Mobile Applications, Self-Management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    After the physician involved in the study asks the participants for their biochemical tests (FBC, HbA1C, LDL-C, HDL-C, Total K, Triglyceride), the outpatient dietitian will give routine nutrition education to the participants. In addition, a data collection form including socio-demographic information, health history, nutrition history and height, weight, waist circumference measurements will be made and filled by the thesis student.
    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    The software developed for this research will be downloaded to the phones of the participants in the intervention group. With this software prepared, written and visual information (pictures, mini-videos) will be given to participants every day for 3 months on diabetes, self-management of diabetes and nutrition. Whether the participants read the messages or not will also be monitored through this software. At the end of 3 months, the participants in the intervention and control groups will be invited again, and their biochemical parameters and self-management status will be measured according to the diabetes self-management scale. Data will be collected through face-to-face interviews in the outpatient clinic, and weight will be measured with the bioelectrical impedance analyzer in the outpatient clinic, height will be measured with a height meter fixed to the wall, and waist circumference will be measured with a non-stretchable measuring tape.
    Intervention Type
    Other
    Intervention Name(s)
    Mobile Application Supported Nutrition and Diabetes Education
    Intervention Description
    With this intervention, the difference between the mobile application supported nutrition diabetes education created with written and visual (video) and face-to-face nutrition and diabetes education will be found.
    Primary Outcome Measure Information:
    Title
    The effect of mobile application supported diabetes education on type 2 diabetes self-management.
    Description
    Type 2 diabetes self-management scores of the participants in the study group and control group will be compared. For this comparison, the "Type 2 Diabetes Self-Management Scale" consisting of 3 sub-titles (Healthy Lifestyle Behaviors, Blood Sugar Management, Health Services Use) and 19 items developed in 2020 will be applied. (Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1 point). Those with higher scores will be considered to show better self-management. This scale will first be administered to the participants when they are diagnosed with type 2 diabetes in the hospital. Participants will be given diabetes and nutrition education for 3 months, and the Type 2 Diabetes Self-Management Scale will be repeated by inviting them to the hospital for control. Then, the participants will be taken into a 3-month follow-up process and at the end of the process, they will be invited to the hospital for control and the Type 2 Diabetes Self-Management Scale will be repeated.
    Time Frame
    6 Month
    Title
    The effect of mobile application supported diabetes education on blood sugar
    Description
    The physician participating in the study will measure the Fasting Blood Sugar (mg/dl) values of the participants. When the participants are diagnosed with type 2 diabetes, their Fasting Blood Sugar (mg/dl) values will be measured and a 3-month diabetes education will be given. At the end of this diabetes training, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again. Then, the participants will be taken to the 3-month follow-up process and at the end of the process, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again. At the end of the research, the effects of mobile application supported diabetes education on fasting blood sugar (mg/dl) will be compared with the routine diabetes education given in the hospital.
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed type 2 diabetes patients in the endocrinology and metabolism outpatient clinic of Ege University Medical Faculty Hospital. Patients with Type 2 DM, between the ages of 18-64, using smart phones and having regular internet will be included in the study. Exclusion Criteria: Those who receive regular messages every day will be checked, and those who do not open/read more than 25% of the messages in total will be excluded. type 1 diabetes or gestational diabetes

    12. IPD Sharing Statement

    Citations:
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    Links:
    URL
    https://diabetesatlas.org/atlas/tenth-edition/
    Description
    Diabetes Atlas-Tenth Edition
    URL
    https://diabetesjournals.org/spectrum/article/20/4/221/70090/From-DSME-to-DSMS-Developing-Empowerment-Based
    Description
    Diabetes Self-Management Support
    URL
    https://www.cdc.gov/diabetes/dsmes-toolkit/standards/index.html
    Description
    Diabetes Self-Management Education and Support (DSMES)

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