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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Lucija Gosak
- Telefonnummer: +386 2 300 47 35
- E-Mail: lucija.gosak2@um.si
Studieren Sie die Kontaktsicherung
- Name: Gregor Stiglic, PhD
- Telefonnummer: +386 41 660 097
- E-Mail: gregor.stiglic@um.si
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Kein Eingriff: Control group
Patients will receive treatment from medical staff (as usual).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Assessment of change in self-care
Zeitfenster: 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
|
|
Assessment of change in disease perception
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: up to 6 months
|
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
|
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Change in blood sugar
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lucija Gosak, University of Maribor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche 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?
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 03/5R-2021
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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