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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979559
• Other study ID #: KE/FK/1375/EC/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: November 2021

Study information

• Verified date: July 2021
• Source: Gadjah Mada University
• Contact: Yaltafit A Jeem
• Phone: +62 856-4366-1294
• Email: yaltafit.abror.j[@]ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Device:
• Mobile health apps
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion

Other:
• Standard care
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting

Locations

Country	Name	City	State
Indonesia	Kalasan PHC	Sleman	Yogyakarta

Sponsors (2)

Lead Sponsor	Collaborator
Gadjah Mada University	Universitas Islam Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	Hemoglobin A1c mean change from baseline	Participants' Hemoglobin A1c measured from vein blood in percent	at baseline and after intervention at 12-weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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