Clinical trial NCT06060743: Examining the Effect of Mobile Application on Insulin Use Perception and Self-Management
Official title: Examining the Effect of the Mobile Application Developed for Individuals With Type 2 Diabetes Using Insulin on the Perception of Insulin Use and Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: type 2 diabetes mellitus
mobile application
Self-Management
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-09-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It consists of two groups, application and control, and three follow-ups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of the research is; To develop a mobile application for individuals with Type 2 diabetes who use insulin and to examine the effect of the developed mobile application on the perception and self-management of insulin use.

Detailed description: In recent years, an increase in insulin use has been observed in individuals with Type 2 DM. Since any mistake in insulin use can lead to hyperglycemic crisis or severe hypoglycemia, correct administration of insulin forms the basis of successful diabetes management. Errors related to insulin therapy are defined as important and correctable medication errors. Such errors related to insulin therapy can potentially occur at every step of diabetes management.

It is stated that interventions that can provide effective self-management and behavioral change can be planned by evaluating individuals' perceptions of the disease and treatment in diabetes management. In our country, only one thesis study evaluating the effect of video-supported teaching given to type 2 diabetic patients on insulin self-management and application skills has been found. This study found that video-assisted instruction given to patients with Type 2 diabetes increased their ability to administer insulin injections and their self-management. In the thesis study in question, the video was shot by the researcher using a model, and individuals who had been using insulin for at least one year were included in the study. In this project, a mobile application for insulin use will be developed and this application will include three separate videos, two of which are animation videos, and a game for insulin use. Our study will be conducted on individuals who will use insulin for the first time, and no study has been found in our country with this sample and population.

When global goals for sustainable development are examined, it is aimed to "promote mental health and well-being by reducing premature deaths from non-communicable diseases by one third through prevention and treatment by 2030". The development of technology and its availability in every aspect of life has also affected patient care, and technological devices and mobile applications have been integrated into patient care. Studies show that the mobile applications used are effective in managing the disease and maintaining self-care activities in individuals with Type 2 DM. In chronic disease management, both compliance with treatment and self-management can be made permanent with mobile applications developed specifically for the disease.

In the research, the educational material was created with an animated video, and the created video was transferred to the mobile application. Thus, the patient will be able to access the educational content via the mobile application at any time and experience the insulin administration steps countless times on the mobile application. By giving feedback from the application regarding the mistakes made during the application, the user will be able to see at what point he made a mistake. Audiovisual materials used in patient education positively affect learning because they appeal to more than one sensory organ. Utilizing technology and using visual and auditory stimuli in patient education will strengthen learning, and the skills aimed to be acquired with the educational material will become more permanent.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* Aware and communicative,
* Those diagnosed with Type 2 DM and using insulin for the first time
* Able to administer insulin on his own,
* Able to use Android based phone,
* Having a digital literacy scale score above 17,
* Agreeing to participate in the research

Exclusion Criteria:

* Under 18 years of age,
* Having vision problems,
* Do not have an Android phone,
* Unconscious and unable to communicate,
* Not having sufficient motor skills,
* Those who did not agree to participate in the research

Primary outcomes:
measure: insulin information sheet
timeFrame: two weeks
Secondary outcomes:
measure: Insulin Treatment Appraisal Scale
timeFrame: two weeks
measure: Insulin Therapy Self-Management Scale
timeFrame: two weeks
measure: Insulin Injection Skill Observation Form
timeFrame: Evaluated at first and last follow-up/ four weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
affiliation: Ege University
name: Nedime Hazal Doner
role: PRINCIPAL_INVESTIGATOR
References: