Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study

Conditions
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PreDiabetes, Prediabetic State

Intervention / Treatment
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* Device: Mobile health apps
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to one of two arms: (1) a group that is used mobile health application intervention for screening and early intervention and (2) a group that receive standard care for screening and early intervention from PHCs regular practice.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth apps<br>The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states. | Device: Mobile health apps<br>* Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion<br>|
| Active Comparator: Standard care<br>The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state. | Other: Standard care<br>* Regular practice for screening and early intervention for prediabetes patient in primary health cares setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight mean change from baseline | 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 | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of screening instrument compared to American Diabetes Association criteria | screening accuracy of the instrument reported using graph | immediately after the intervention begin | 
| Sensitivity value of screening instrument compared to American Diabetes Association criteria | 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 | 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 | 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 | 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 | 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 | Likelihood ratio of the instrument calculated using formula derived from 2x2 tables of diagnostic test | immediately after the intervention begin | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Intervention, Screening, Self Care, Primary Health Care