The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care
Primary Purpose
Type 2 Diabetes, Diabetes Mellitus, Type 2, Disease, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile app forDiabetes (Tessera Multimedia, 2020)
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patients using mobile applications
Control group
Arm Description
Patients diagnosed with type 2 diabetes will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
Patients will receive treatment from medical staff (as usual).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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%.
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04999189
Brief Title
The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care
Official Title
Effectiveness of Using a Mobile Self-care Application in the Management of a Patient With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Maribor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Diabetes Mellitus, Type 2, Disease, Chronic, Self-Care, Health Behavior, Mobile Apps, Mobile Phone Use
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Masking will not be possible as participants will know to which group they are assigned. The medical staff will also know this as they will teach them how to use the mobile app.
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients using mobile applications
Arm Type
Experimental
Arm Description
Patients diagnosed with type 2 diabetes will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive treatment from medical staff (as usual).
Intervention Type
Other
Intervention Name(s)
Mobile app forDiabetes (Tessera Multimedia, 2020)
Intervention Description
Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
Primary Outcome Measure Information:
Title
Assessment of change in self-care
Description
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.
Time Frame
up to 6 months
Title
Assessment of change in disease perception
Description
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.
Time Frame
up to 6 months
Title
Frequency of using the mobile application
Description
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.
Time Frame
up to 6 months
Title
Change in body weight
Description
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.
Time Frame
up to 6 months
Title
Change in glycated hemoglobin
Description
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%.
Time Frame
up to 6 months
Title
Change in blood sugar
Description
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.
Time Frame
up to 6 months
Title
Change in blood pressure
Description
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).
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucija Gosak
Phone
+386 2 300 47 35
Email
lucija.gosak2@um.si
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor Stiglic, PhD
Phone
+386 41 660 097
Email
gregor.stiglic@um.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucija Gosak
Organizational Affiliation
University of Maribor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16731240
Citation
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.
Results Reference
background
PubMed Identifier
35713944
Citation
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.
Results Reference
derived
Links:
URL
https://play.google.com/store/apps/details?id=gr.tessera.fordiabetesapp&hl=en&gl=US
Description
Tessera Multimedia, 2020. forDiabetes: diabetes self-management app. [Online] Google Play Store.
URL
https://bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-017-0218-y
Description
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.
URL
https://www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings
Description
American Heart Association. What do your blood pressure numbers mean?
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The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care
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