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

22. juli 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

350

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Indonesia
    • Yogyakarta
      • Sleman, Yogyakarta, Indonesia, 55571

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: mHealth apps
The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.
Enhet: 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.
Annen: Standard care
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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Sponsor

Gadjah Mada University

Samarbeidspartnere

Universitas Islam Indonesia

Etterforskere

  • Hovedetterforsker: Yaltafit A Jeem, Gadjah Mada University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. mai 2021

Primær fullføring (Forventet)

1. oktober 2021

Studiet fullført (Forventet)

1. november 2021

Datoer for studieregistrering

Først innsendt

20. juni 2021

Først innsendt som oppfylte QC-kriteriene

22. juli 2021

Først lagt ut (Faktiske)

28. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KE/FK/1375/EC/2020

Plan for individuelle deltakerdata (IPD)

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