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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
University Maribor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 23, 2021
    Last Updated
    August 8, 2021
    Sponsor
    University Maribor
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    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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