Clinical trial NCT04979559: Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
Official title: Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Prediabetic State
Keywords: Telemedicine
Intervention
Screening
Self Care
Primary Health Care
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: Universitas Islam Indonesia
First posted: 2021-07-28
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight mean change from baseline
timeFrame: at baseline and after intervention at 12-weeks
measure: Waist circumference mean change from baseline
timeFrame: at baseline and after intervention at 12-weeks
measure: Fasting blood glucose mean change from baseline
timeFrame: at baseline and after intervention at 12-weeks
measure: Hemoglobin A1c mean change from baseline
timeFrame: at baseline and after intervention at 12-weeks
measure: Oral glucose tolerance test mean change from baseline
timeFrame: at baseline and after intervention at 12-weeks
Secondary outcomes:
measure: Area under the curve of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
measure: Sensitivity value of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
measure: Specificity value of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
measure: Positive predictive value of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
measure: Negative predictive value of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
measure: Accuracy value of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
measure: Likelihood ratio of screening instrument compared to American Diabetes Association criteria
timeFrame: immediately after the intervention begin
Other outcomes:
measure: Participant's acceptance of mobile health application
timeFrame: after intervention at 12-weeks
Locations:
city: Sleman
country: Indonesia
facility: Kalasan PHC
state: Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: Yaltafit A Jeem
role: PRINCIPAL_INVESTIGATOR
References: