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

Sponsor
Ege University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05228561
Collaborator
(none)
140
2
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mobile Application Supported Nutrition and Diabetes Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

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.

Experimental: Study Group

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.

Other: Mobile Application Supported Nutrition and Diabetes Education
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.

Outcome Measures

Primary Outcome Measures

  1. The effect of mobile application supported diabetes education on type 2 diabetes self-management. [6 Month]

    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.

  2. The effect of mobile application supported diabetes education on blood sugar [6 Months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
EMRE TURHAN, Graduate Student, Ege University
ClinicalTrials.gov Identifier:
NCT05228561
Other Study ID Numbers:
  • EgeUniversity-ETURHAN-001
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022