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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Yaltafit A Jeem
- Номер телефона: +62 856-4366-1294
- Электронная почта: yaltafit.abror.j@ugm.ac.id
Учебное резервное копирование контактов
- Имя: Russy N Andriani
- Номер телефона: +6287821562151
- Электронная почта: russy.novita@gmail.com
Места учебы
-
-
Yogyakarta
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Sleman, Yogyakarta, Индонезия, 55571
- Рекрутинг
- Kalasan PHC
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Контакт:
- Yaltafit A Jeem
- Номер телефона: +62 856-4366-1294
- Электронная почта: yaltafit.abror.j@ugm.ac.id
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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
|
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Активный компаратор: 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
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Body weight mean change from baseline
Временное ограничение: 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
Временное ограничение: 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
|
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Fasting blood glucose mean change from baseline
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Area under the curve of screening instrument compared to American Diabetes Association criteria
Временное ограничение: immediately after the intervention begin
|
screening accuracy of the instrument reported using graph
|
immediately after the intervention begin
|
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Sensitivity value of screening instrument compared to American Diabetes Association criteria
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Participant's acceptance of mobile health application
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Yaltafit A Jeem, Gadjah Mada University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KE/FK/1375/EC/2020
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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