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

NCT06060743 | Completed

• 1 other identifier: EU-NF-NHD-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

type 2 diabetes mellitus; mobile application; Self-Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Insulin Treatment Appraisal Scale

  two weeks

• Insulin Therapy Self-Management Scale

  two weeks

• Insulin Injection Skill Observation Form

  Evaluated at first and last follow-up/ four weeks

Study Arms (2)

control group

NO INTERVENTION

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.

application group

EXPERIMENTAL

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.

Other: INS-MOBILE: Mobile Application Developed for Insulin Use

Interventions

INS-MOBILE: Mobile Application Developed for Insulin Use OTHER

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.

application group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University

Izmir, Bornova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nedime Hazal Doner

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the study, groups were determined by block randomization. The randomization list was created by block randomization according to age and gender.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: It consists of two groups, application and control, and three follow-ups.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 25, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)