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

8. august 2021 opdateret af: Lucija Gosak, University Maribor

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

380

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients using mobile applications
Patients diagnosed with type 2 diabetes will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
Andet: Mobile app forDiabetes (Tessera Multimedia, 2020)
Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
Ingen indgriben: Control group
Patients will receive treatment from medical staff (as usual).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of change in self-care
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
up to 6 months
Change in glycated hemoglobin
Tidsramme: 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
Change in blood sugar
Tidsramme: 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.
up to 6 months
Change in blood pressure
Tidsramme: 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).
up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Maribor

Efterforskere

  • Ledende efterforsker: Lucija Gosak, University of Maribor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. september 2021

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

23. juni 2021

Først indsendt, der opfyldte QC-kriterier

8. august 2021

Først opslået (Faktiske)

10. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 03/5R-2021

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