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

22. juli 2021 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

350

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

Studiesteder

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

20 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: mHealth apps
The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.
Enhed: Mobile health apps
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
Aktiv komparator: Standard care
The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.
Andet: Standard care
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight mean change from baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the curve of screening instrument compared to American Diabetes Association criteria
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant's acceptance of mobile health application
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Gadjah Mada University

Samarbejdspartnere

Universitas Islam Indonesia

Efterforskere

  • Ledende efterforsker: Yaltafit A Jeem, Gadjah Mada University

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 (Faktiske)

25. maj 2021

Primær færdiggørelse (Forventet)

1. oktober 2021

Studieafslutning (Forventet)

1. november 2021

Datoer for studieregistrering

Først indsendt

20. juni 2021

Først indsendt, der opfyldte QC-kriterier

22. juli 2021

Først opslået (Faktiske)

28. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KE/FK/1375/EC/2020

Plan for individuelle deltagerdata (IPD)

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