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

Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: PreDiabetes; Prediabetic State
• Intervention / Treatment: Device: Mobile health apps; Other: Standard care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaltafit A Jeem; Phone Number: +62 856-4366-1294; Email: yaltafit.abror.j@ugm.ac.id
• Study Contact Backup: Name: Russy N Andriani; Phone Number: +6287821562151; Email: russy.novita@gmail.com

Study Locations

• Indonesia
  • Yogyakarta
    • Sleman, Yogyakarta, Indonesia, 55571
      • Recruiting
      • Kalasan PHC
      • Contact: Yaltafit A Jeem; Phone Number: +62 856-4366-1294; Email: yaltafit.abror.j@ugm.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mHealth apps; The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.	Device: Mobile health apps; Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
Active Comparator: Standard care; The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.	Other: Standard care; Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight mean change from baseline	Participants' body weight measured by scales using kilograms (kg) measurement unit	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	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	at baseline and after intervention at 12-weeks
Hemoglobin A1c mean change from baseline	Participants' Hemoglobin A1c measured from vein blood in percent	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	at baseline and after intervention at 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve of screening instrument compared to American Diabetes Association criteria	screening accuracy of the instrument reported using graph	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	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	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	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	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	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	immediately after the intervention begin

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's acceptance of mobile health application	evaluation of participant's acceptance to the device using Mobile Health Application Acceptance Questioner adapted from previous study	after intervention at 12-weeks

Collaborators and Investigators

• Sponsor: Gadjah Mada University
• Collaborators: Universitas Islam Indonesia
• Investigators: Principal Investigator: Yaltafit A Jeem, Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Primary Health Care; Screening; Intervention; Self Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: KE/FK/1375/EC/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No