Examining the Effect of Mobile Application on Insulin Use Perception and Self-Management

Type 2 Diabetes Treated With Insulin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06060743
• Other study ID #: EU-NF-NHD-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 25, 2023

Study information

• Verified date: September 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 25, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

Other:
• INS-MOBILE: Mobile Application Developed for Insulin Use
After determining the application and control groups in the research, the purpose of the research was explained to both groups. Participants were informed that the application would last 1 month. It was explained that data collection forms would be filled out before the application (Z0), on the 14th day of the application (Z1), and on the 28th day of the application (Z2). On the 0th and 28th days of the follow-up, the participants' insulin administration skills were evaluated face-to-face by the researcher using the Insulin Therapy Skill Observation Form. In addition to the standard training given by diabetes training nurses, a mobile application on insulin use was sent to the application group, while the control group was given standard training only by diabetes training nurses.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir	Bornova

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin information sheet	This form, created by the researchers after literature review, consists of 25 questions. This form includes questions about general information about insulins, insulin storage conditions, injection preparation stages, injection sites and injection technique. The form is answered as True/False. The questions in the form were evaluated out of 100 points.	two weeks
Secondary	Insulin Treatment Appraisal Scale	The scale consists of two subscales, positive and negative attitude, and 20 items. Scale items are rated on a Likert type scale between "strongly disagree", 1 point, and "strongly agree", 5 points.	two weeks
Secondary	Insulin Therapy Self-Management Scale	The scale consists of 32 items with a three-factor structure, scored using a five-point Likert-type scale.	two weeks
Secondary	Insulin Injection Skill Observation Form	It consists of 21 items including the stages of insulin injection.	Evaluated at first and last follow-up/ four weeks