Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
22 de julio de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
350
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yaltafit A Jeem
- Número de teléfono: +62 856-4366-1294
- Correo electrónico: yaltafit.abror.j@ugm.ac.id
Copia de seguridad de contactos de estudio
- Nombre: Russy N Andriani
- Número de teléfono: +6287821562151
- Correo electrónico: russy.novita@gmail.com
Ubicaciones de estudio
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-
Yogyakarta
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Sleman, Yogyakarta, Indonesia, 55571
- Reclutamiento
- Kalasan PHC
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Contacto:
- Yaltafit A Jeem
- Número de teléfono: +62 856-4366-1294
- Correo electrónico: yaltafit.abror.j@ugm.ac.id
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
|
|
Comparador activo: Standard care
The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.
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Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body weight mean change from baseline
Periodo de tiempo: at baseline and after intervention at 12-weeks
|
Participants' body weight measured by scales using kilograms (kg) measurement unit
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at baseline and after intervention at 12-weeks
|
|
Waist circumference mean change from baseline
Periodo de tiempo: at baseline and after intervention at 12-weeks
|
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
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at baseline and after intervention at 12-weeks
|
|
Fasting blood glucose mean change from baseline
Periodo de tiempo: at baseline and after intervention at 12-weeks
|
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
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at baseline and after intervention at 12-weeks
|
|
Hemoglobin A1c mean change from baseline
Periodo de tiempo: at baseline and after intervention at 12-weeks
|
Participants' Hemoglobin A1c measured from vein blood in percent
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at baseline and after intervention at 12-weeks
|
|
Oral glucose tolerance test mean change from baseline
Periodo de tiempo: 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
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at baseline and after intervention at 12-weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area under the curve of screening instrument compared to American Diabetes Association criteria
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Specificity value of screening instrument compared to American Diabetes Association criteria
Periodo de tiempo: 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
|
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Positive predictive value of screening instrument compared to American Diabetes Association criteria
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Accuracy value of screening instrument compared to American Diabetes Association criteria
Periodo de tiempo: 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
|
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Likelihood ratio of screening instrument compared to American Diabetes Association criteria
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant's acceptance of mobile health application
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yaltafit A Jeem, Gadjah Mada University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de mayo de 2021
Finalización primaria (Anticipado)
1 de octubre de 2021
Finalización del estudio (Anticipado)
1 de noviembre de 2021
Fechas de registro del estudio
Enviado por primera vez
20 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2021
Publicado por primera vez (Actual)
28 de julio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2021
Última verificación
1 de julio de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KE/FK/1375/EC/2020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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