The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effectiveness of Using a Mobile Self-care Application in the Management of a Patient With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04999189
• Other study ID #: 03/5R-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2021
• Source: University Maribor
• Contact: Lucija Gosak
• Phone: +386 2 300 47 35
• Email: lucija.gosak2[@]um.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to evaluate and test the usefulness of the mobile application forDiabetes to improve the self-care of individuals with diabetes type 1. The investigators want to obtain the missing evidence from the field of application operation and their impact on individuals' self-care and study the acceptance of applications among healthcare staff, which plays an essential role in patient education.

Description:

The investigators will conduct a randomized study in which individuals included in the intervention group will use the forDiabetes app to self-care for their type 2 diabetes throughout the study. A randomized controlled trial will be conducted in family medicine clinics throughout Slovenia. At the start of the observation and the first control visit, the investigators will assess self-care and disease perception of individuals with the help of validated questionnaires. Measurement of body weight, blood pressure, blood sugar monitoring, and glycated hemoglobin will also be performed at the observation and a first control visit. For individuals who will use the forDiabetes application during the research, the investigators will also assess the frequency of using the mobile application in the home environment at the first control visit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients older than 18 years;

• with regulated and diagnosed type 2 diabetes;

• patients who are managed in a family medicine clinic;

• patients who have the option of using a mobile phone and a blood sugar meter in the home environment.

Exclusion Criteria:

• patients diagnosed with type 1 diabetes;

• patients who have chronic complications as a result of diabetes.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Disease, Chronic
• Health Behavior
• Mobile Apps
• Mobile Phone Use
• Self-Care
• Type 2 Diabetes

Intervention

Other:
• Mobile app forDiabetes (Tessera Multimedia, 2020)
Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Maribor

References & Publications (1)

Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change in self-care	Self-care in individuals with type 2 diabetes will be assessed using the Self-Care of Diabetes Inventory (SCODI) questionnaire from Ausili et al., 2017. The tool consists of 40 assumptions classified into four dimensions: self-care maintenance (12 assumptions), self-care implementation (8 assumptions), self-care monitoring (9 assumptions), and self-confidence (11 assumptions). The instrument is assessed using the Likert scale, where a higher score represents better self-care.; Change in SCODI score will be assessed at the enrolment of the patient followed by the examination in the period of up to 6 months after the enrolment.	up to 6 months
Primary	Assessment of change in disease perception	The investigators will use the "Brief Illness Perception Questionnaire" (Brief IPQ) to assess disease perception from authors Broadbent, et al., 2006. The questionnaire provides a rapid assessment of disease perception and measures the patient's cognitive and emotional representations of their disease. The questionnaire contains eight graded questions on a 10-point scale and one open-ended question. The higher the score, the more threatening the individual's view of the disease.; Change in Brief IPQ score will be assessed at the enrolment of the patient followed by the examination in the period of up to 6 months after the enrolment.	up to 6 months
Primary	Frequency of using the mobile application	The investigators will assess the frequency of use at the first check-up for individuals who will use the application during the research. The questions were partially summarized after the "Video Games Preference Inventory" survey questionnaire from authors Kenny & McDaniel, 2011. In its primary form, the survey questionnaire consists of ten questions. The investigators summarized the first five questions for our research, which the investigators also adapted according to the research content. The questions are rated on the Likert scale (1 = Strongly disagree; 2 = Disagree; 3 = No opinion; 4 = Agree; 5 = Strongly agree). The higher the average rating the user receives, the higher the mobile application level.; Frequency of the mobile application use will be collected at the examination in the period of up to 6 months after the enrolment.	up to 6 months
Primary	Change in body weight	The registered nurse will measure the patient's body weight with the help of a calibrated technique before the start of the research and at the first examination. The investigators are interested in whether the use of the mobile application will have an effect on weight loss.	up to 6 months
Primary	Change in glycated hemoglobin	The registered nurse will measure the patient's glycated hemoglobin with the help of a calibrated glycated hemoglobin monitor before the start of the research and at the first check-up. The investigators will be able to see if the glycated hemoglobin level has decreased in the time before the examination until the first examination. Recommended target HbA1c is less than 7%.	up to 6 months
Primary	Change in blood sugar	The registered nurse will measure the patient's blood sugar with the help of a calibrated blood sugar monitor before the start of the research and at the first check-up. The investigators will be able to see if the blood sugar level has decreased in the time before the examination until the first examination.	up to 6 months
Primary	Change in blood pressure	The registered nurse will measure the patient's blood pressure with the help of a calibrated blood pressure monitor before the start of the research and at the first check-up. Based on the American Heart Association, these values can be divided into categories (Normal = systolic less than 120, and diastolic less than 80; elevated = systolic between 120 and 129, and diastolic less than 80; hypertension stage 1 = systolic between 130, and 139, or diastolic between 80, and 89; hypertension stage 2 = systolic 140 or higher, or diastolic 90 or higher; hypertension stage 3 = systolic higher than 180, and/or diastolic higher than 120).	up to 6 months

External Links

•   American Heart Association. What do your blood pressure numbers mean?
•   Ausili, D., et al., 2017. Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory. BMC Endocrine Disorders, 17(1), pp. 66.
•   Kenny, R. F., & McDaniel, R., 2011. The role teachers' expectations and value assessments of video games play in their adopting and integrating them into their classrooms. British Journal of Educational Technology, 42(2), pp. 197-213.
•   Tessera Multimedia, 2020. forDiabetes: diabetes self-management app. [Online] Google Play Store.