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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yaltafit A Jeem
- Numéro de téléphone: +62 856-4366-1294
- E-mail: yaltafit.abror.j@ugm.ac.id
Sauvegarde des contacts de l'étude
- Nom: Russy N Andriani
- Numéro de téléphone: +6287821562151
- E-mail: russy.novita@gmail.com
Lieux d'étude
-
-
Yogyakarta
-
Sleman, Yogyakarta, Indonésie, 55571
- Recrutement
- Kalasan PHC
-
Contact:
- Yaltafit A Jeem
- Numéro de téléphone: +62 856-4366-1294
- E-mail: yaltafit.abror.j@ugm.ac.id
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body weight mean change from baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Area under the curve of screening instrument compared to American Diabetes Association criteria
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant's acceptance of mobile health application
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Yaltafit A Jeem, Gadjah Mada University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KE/FK/1375/EC/2020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .