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.
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: 1. To portray regular prediabetes screening and early intervention practice in PHCs. 2. To assess prediabetes screening and early intervention data necessity for mobile health application model at PHCs. 3. To assess the feasibility of mobile health application usage for screening and early intervention of prediabetes patients at PHCs. 4. 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. 5. To assess the impact of early intervention using mobile health applications on prediabetes patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
350
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
Kalasan PHC
Sleman, Special Region of Yogyakarta, Indonesia
RECRUITINGBody weight mean change from baseline
Participants' body weight measured by scales using kilograms (kg) measurement unit
Time frame: 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
Time frame: 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
Time frame: at baseline and after intervention at 12-weeks
Hemoglobin A1c mean change from baseline
Participants' Hemoglobin A1c measured from vein blood in percent
Time frame: 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
Time frame: at baseline and after intervention at 12-weeks
Area under the curve of screening instrument compared to American Diabetes Association criteria
screening accuracy of the instrument reported using graph
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: immediately after the intervention begin
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