Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Waist circumference mean change from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participant and care provider in each site are unaware of the group allocation.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •severe medical condition
- •disability to perform physical activity
结局指标
主要结局
Waist circumference mean change from baseline
时间窗: at baseline and after intervention at 12-weeks
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
Body weight mean change from baseline
时间窗: at baseline and after intervention at 12-weeks
Participants' body weight measured by scales using kilograms (kg) measurement unit
Fasting blood glucose mean change from baseline
时间窗: at baseline and after intervention at 12-weeks
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
Hemoglobin A1c mean change from baseline
时间窗: at baseline and after intervention at 12-weeks
Participants' Hemoglobin A1c measured from vein blood in percent
Oral glucose tolerance test mean change from baseline
时间窗: 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
次要结局
- Area under the curve of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
- Sensitivity value of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
- Specificity value of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
- Positive predictive value of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
- Negative predictive value of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
- Accuracy value of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
- Likelihood ratio of screening instrument compared to American Diabetes Association criteria(immediately after the intervention begin)
研究者
Yaltafit Abror Jeem
Principle investigator
Gadjah Mada University