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

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
INS-MOBILE: Mobile Application Developed for Insulin Use
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Treated With Insulin focused on measuring type 2 diabetes mellitus, mobile application, Self-Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

application group

Arm Description

Data collection tools were applied to individuals in the control group on day 0 (Z0), day 14 (Z1) and day 28 (Z2) of follow-up. Data collection tools applied to the control group are as follows: Patient Introduction Form, Insulin Treatment Appraisal Scale,, Insulin Therapy Self-Management Scale, Insulin Information Form, Insulin Injection Skill Observation Form and Metabolic Control Variables Form.

Individuals in the application group will be given individual training on how to use the application through the application demo. Data collection forms will be applied to individuals in the application group on day 0 (Z0), day 14 (Z1) and day 28 (Z2). The forms to be used are: Patient Introduction Form, Insulin Treatment Appraisal Scale, Insulin Therapy Self-Management Scale, Insulin Information Form, Metabolic Control Variables Form, Insulin Injection Skill Observation Form and Digital Literacy Scale.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Insulin Therapy Self-Management Scale
The scale consists of 32 items with a three-factor structure, scored using a five-point Likert-type scale.
Insulin Injection Skill Observation Form
It consists of 21 items including the stages of insulin injection.

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Ege University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT06060743
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
The Scientific and Technological Research Council of Turkey

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin
Keywords
type 2 diabetes mellitus, mobile application, Self-Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It consists of two groups, application and control, and three follow-ups.
Masking
ParticipantOutcomes Assessor
Masking Description
In the study, groups were determined by block randomization. The randomization list was created by block randomization according to age and gender.
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Data collection tools were applied to individuals in the control group on day 0 (Z0), day 14 (Z1) and day 28 (Z2) of follow-up. Data collection tools applied to the control group are as follows: Patient Introduction Form, Insulin Treatment Appraisal Scale,, Insulin Therapy Self-Management Scale, Insulin Information Form, Insulin Injection Skill Observation Form and Metabolic Control Variables Form.
Arm Title
application group
Arm Type
Experimental
Arm Description
Individuals in the application group will be given individual training on how to use the application through the application demo. Data collection forms will be applied to individuals in the application group on day 0 (Z0), day 14 (Z1) and day 28 (Z2). The forms to be used are: Patient Introduction Form, Insulin Treatment Appraisal Scale, Insulin Therapy Self-Management Scale, Insulin Information Form, Metabolic Control Variables Form, Insulin Injection Skill Observation Form and Digital Literacy Scale.
Intervention Type
Other
Intervention Name(s)
INS-MOBILE: Mobile Application Developed for Insulin Use
Intervention Description
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.
Primary Outcome Measure Information:
Title
insulin information sheet
Description
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.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Insulin Treatment Appraisal Scale
Description
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.
Time Frame
two weeks
Title
Insulin Therapy Self-Management Scale
Description
The scale consists of 32 items with a three-factor structure, scored using a five-point Likert-type scale.
Time Frame
two weeks
Title
Insulin Injection Skill Observation Form
Description
It consists of 21 items including the stages of insulin injection.
Time Frame
Evaluated at first and last follow-up/ four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nedime Hazal Doner
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University
City
İzmir
State/Province
Bornova
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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