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

NCT ID: NCT04979559

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2021-11-30

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.

Conditions

PreDiabetes; Prediabetic State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

mHealth apps

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

Group Type: EXPERIMENTAL

Mobile health apps

Intervention Type: DEVICE

Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion

Standard care

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

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

Interventions

Mobile health apps

Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion

Intervention Type: DEVICE

Standard care

Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Islam Indonesia

UNKNOWN

Sponsor Role: collaborator

Gadjah Mada University

OTHER

Sponsor Role: lead

Responsible Party

Yaltafit Abror Jeem

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaltafit A Jeem

Role: PRINCIPAL_INVESTIGATOR

Gadjah Mada University

Locations

Kalasan PHC

Sleman, Special Region of Yogyakarta, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Yaltafit A Jeem

Role: CONTACT

yaltafit.abror.j@ugm.ac.id

+62 856-4366-1294

Russy N Andriani

Role: CONTACT

russy.novita@gmail.com

+6287821562151

Facility Contacts

Yaltafit A Jeem

Role: primary

yaltafit.abror.j@ugm.ac.id

+62 856-4366-1294

Other Identifiers

KE/FK/1375/EC/2020

Identifier Type: -

Identifier Source: org_study_id