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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yaltafit A Jeem
- 电话号码：+62 856-4366-1294
- 邮箱：yaltafit.abror.j@ugm.ac.id
研究联系人备份
- 姓名：Russy N Andriani
- 电话号码：+6287821562151
- 邮箱：russy.novita@gmail.com
学习地点
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Yogyakarta
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Sleman、Yogyakarta、印度尼西亚、55571
- 招聘中
- Kalasan PHC
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接触：
- Yaltafit A Jeem
- 电话号码：+62 856-4366-1294
- 邮箱：yaltafit.abror.j@ugm.ac.id
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body weight mean change from baseline
大体时间：at baseline and after intervention at 12-weeks
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Participants' body weight measured by scales using kilograms (kg) measurement unit
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at baseline and after intervention at 12-weeks
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Waist circumference mean change from baseline
大体时间：at baseline and after intervention at 12-weeks
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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
大体时间：at baseline and after intervention at 12-weeks
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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
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Hemoglobin A1c mean change from baseline
大体时间：at baseline and after intervention at 12-weeks
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Participants' Hemoglobin A1c measured from vein blood in percent
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at baseline and after intervention at 12-weeks
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Oral glucose tolerance test mean change from baseline
大体时间：at baseline and after intervention at 12-weeks
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area under the curve of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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screening accuracy of the instrument reported using graph
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immediately after the intervention begin
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Sensitivity value of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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Sensitivity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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Specificity value of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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Specificity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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Positive predictive value of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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Positive predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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Negative predictive value of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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Negative predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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Accuracy value of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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Accuracy predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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Likelihood ratio of screening instrument compared to American Diabetes Association criteria
大体时间：immediately after the intervention begin
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Likelihood ratio of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant's acceptance of mobile health application
大体时间：after intervention at 12-weeks
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evaluation of participant's acceptance to the device using Mobile Health Application Acceptance Questioner adapted from previous study
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after intervention at 12-weeks
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合作者和调查者
调查人员
- 首席研究员：Yaltafit A Jeem、Gadjah Mada University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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