Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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:
- To portray regular prediabetes screening and early intervention practice in PHCs.
- To assess prediabetes screening and early intervention data necessity for mobile health application model at PHCs.
- To assess the feasibility of mobile health application usage for screening and early intervention of prediabetes patients at PHCs.
- 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.
- To assess the impact of early intervention using mobile health applications on prediabetes patients.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Yaltafit A Jeem
- Telefonnummer: +62 856-4366-1294
- E-Mail: yaltafit.abror.j@ugm.ac.id
Studieren Sie die Kontaktsicherung
- Name: Russy N Andriani
- Telefonnummer: +6287821562151
- E-Mail: russy.novita@gmail.com
Studienorte
-
-
Yogyakarta
-
Sleman, Yogyakarta, Indonesien, 55571
- Rekrutierung
- Kalasan PHC
-
Kontakt:
- Yaltafit A Jeem
- Telefonnummer: +62 856-4366-1294
- E-Mail: yaltafit.abror.j@ugm.ac.id
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: mHealth apps
The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.
|
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
|
|
Aktiver Komparator: Standard care
The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.
|
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Body weight mean change from baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area under the curve of screening instrument compared to American Diabetes Association criteria
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participant's acceptance of mobile health application
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Yaltafit A Jeem, Gadjah Mada University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KE/FK/1375/EC/2020
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .