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Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting

22 juli 2021 bijgewerkt door: Yaltafit Abror Jeem, Gadjah Mada University

Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study

Background: Preventing type-2 diabetes mellitus begins with early screening and intervention of prediabetic participants. Until now, prediabetes screening and early intervention have not been optimal. The rapid advancement of technology, as well as its increased use, may provide an opportunity to improve the quality and cost of healthcare services. It is quite practicable to investigate and implement a valid, practical and easy-to-use mobile health application for participants and health staffs in screening and early intervention of prediabetes participants at primary health cares setting. This protocol aimed to identify and develop a valid, practical, and easy-to-use mobile health application for screening and early intervention of prediabetes participants at primary health cares.

Methods: This protocol was prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This is a mixed-methods study with sequential exploratory approach. This project will begin with in-depth interview to gather qualitative information regarding mobile health application necessity for prediabetes participants at the primary health cares. The impact of the usage will be studied quantitatively using randomized controlled trial. Prediabetic participants and primary health cares staffs at Yogyakarta province will be the research subjects. The collected findings will be examined based on the type of the data.

Discussion: The proposed research aimed to obtain information and trial results regarding mobile health application usage for prediabetes participants screening and early intervention at primary health cares setting.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The goal of this study is to create a mobile health application for prediabetes patients that included screening and early intervention in Primary Health Cares (PHCs) setting. More specifically, the objectives are as follows:

  1. To portray regular prediabetes screening and early intervention practice in PHCs.
  2. To assess prediabetes screening and early intervention data necessity for mobile health application model at PHCs.
  3. To assess the feasibility of mobile health application usage for screening and early intervention of prediabetes patients at PHCs.
  4. To assess internal and external factors that influence the intention-to-use, easiness, and usefulness of mobile health applications for prediabetes patients and health staff.
  5. To assess the impact of early intervention using mobile health applications on prediabetes patients.

Studietype

Ingrijpend

Inschrijving (Verwacht)

350

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • diagnosed as the prediabetic state using American Diabetes Association (ADA) criteria
  • have no previous diagnosis of type 2 diabetes or history of taking anti-hyperglycemic drugs
  • have access to and able to use a personal smartphone
  • willing to undertake study activities and written informed consent

Exclusion Criteria:

  • severe medical condition
  • disability to perform physical activity

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Screening
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: mHealth apps
The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.
Apparaat: Mobile health apps
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
Actieve vergelijker: Standard care
The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.
Ander: Standard care
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight mean change from baseline
Tijdsspanne: at baseline and after intervention at 12-weeks
Participants' body weight measured by scales using kilograms (kg) measurement unit
at baseline and after intervention at 12-weeks
Waist circumference mean change from baseline
Tijdsspanne: at baseline and after intervention at 12-weeks
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
at baseline and after intervention at 12-weeks
Fasting blood glucose mean change from baseline
Tijdsspanne: at baseline and after intervention at 12-weeks
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
at baseline and after intervention at 12-weeks
Hemoglobin A1c mean change from baseline
Tijdsspanne: at baseline and after intervention at 12-weeks
Participants' Hemoglobin A1c measured from vein blood in percent
at baseline and after intervention at 12-weeks
Oral glucose tolerance test mean change from baseline
Tijdsspanne: at baseline and after intervention at 12-weeks
Participants' oral glucose tolerance test measured from vein blood in milligram per deciliter (mg/dL) measurement unit
at baseline and after intervention at 12-weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area under the curve of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
screening accuracy of the instrument reported using graph
immediately after the intervention begin
Sensitivity value of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
Sensitivity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
immediately after the intervention begin
Specificity value of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
Specificity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
immediately after the intervention begin
Positive predictive value of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
Positive predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
immediately after the intervention begin
Negative predictive value of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
Negative predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
immediately after the intervention begin
Accuracy value of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
Accuracy predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
immediately after the intervention begin
Likelihood ratio of screening instrument compared to American Diabetes Association criteria
Tijdsspanne: immediately after the intervention begin
Likelihood ratio of the instrument calculated using formula derived from 2x2 tables of diagnostic test
immediately after the intervention begin

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Participant's acceptance of mobile health application
Tijdsspanne: after intervention at 12-weeks
evaluation of participant's acceptance to the device using Mobile Health Application Acceptance Questioner adapted from previous study
after intervention at 12-weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gadjah Mada University

Medewerkers

Universitas Islam Indonesia

Onderzoekers

  • Hoofdonderzoeker: Yaltafit A Jeem, Gadjah Mada University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 mei 2021

Primaire voltooiing (Verwacht)

1 oktober 2021

Studie voltooiing (Verwacht)

1 november 2021

Studieregistratiedata

Eerst ingediend

20 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

22 juli 2021

Eerst geplaatst (Werkelijk)

28 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2021

Laatste update ingediend die voldeed aan QC-criteria

22 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KE/FK/1375/EC/2020

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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