Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-01 @ 5:13 PM
Study NCT ID:
NCT04979559
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
Sponsor:
Gadjah Mada University
Organization:
Study Overview
Official Title:
Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: