The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care
Effectiveness of Using a Mobile Self-care Application in the Management of a Patient With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lucija Gosak
- Phone Number: +386 2 300 47 35
- Email: lucija.gosak2@um.si
Study Contact Backup
- Name: Gregor Stiglic, PhD
- Phone Number: +386 41 660 097
- Email: gregor.stiglic@um.si
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Patients using mobile applications
Patients diagnosed with type 2 diabetes will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
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Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
|
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No Intervention: Control group
Patients will receive treatment from medical staff (as usual).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of change in self-care
Time Frame: up to 6 months
|
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
|
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Assessment of change in disease perception
Time Frame: up to 6 months
|
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
|
|
Frequency of using the mobile application
Time Frame: up to 6 months
|
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
|
|
Change in body weight
Time Frame: up to 6 months
|
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.
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up to 6 months
|
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Change in glycated hemoglobin
Time Frame: up to 6 months
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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%.
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up to 6 months
|
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Change in blood sugar
Time Frame: up to 6 months
|
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.
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up to 6 months
|
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Change in blood pressure
Time Frame: up to 6 months
|
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).
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up to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lucija Gosak, University of Maribor
Publications and helpful links
General Publications
- Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Gosak L, Pajnkihar M, Stiglic G. The Impact of Mobile Health Use on the Self-care of Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 17;11(6):e31652. doi: 10.2196/31652.
Helpful Links
- Tessera Multimedia, 2020. forDiabetes: diabetes self-management app. [Online] Google Play Store.
- 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.
- American Heart Association. What do your blood pressure numbers mean?
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/5R-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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