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

Gadjah Mada University

Status

Unknown

Conditions

Prediabetic State

PreDiabetes

Treatments

Device: Mobile health apps

Other: Standard care

Study type

Interventional

Funder types

Other

Identifiers

NCT04979559

KE/FK/1375/EC/2020

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment

350 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

350 participants in 2 patient groups

mHealth apps

Experimental group

Description:

The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.

Treatment:

Device: Mobile health apps

Standard care

Active Comparator group

Description:

The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.

Treatment:

Other: Standard care