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

Primary Purpose

PreDiabetes, Prediabetic State

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Mobile health apps
Standard care
Sponsored by
Gadjah Mada University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for PreDiabetes focused on measuring Telemedicine, Intervention, Screening, Self Care, Primary Health Care

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Kalasan PHCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mHealth apps

Standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Body weight mean change from baseline
Participants' body weight measured by scales using kilograms (kg) measurement unit
Waist circumference mean change from baseline
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
Fasting blood glucose mean change from baseline
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
Hemoglobin A1c mean change from baseline
Participants' Hemoglobin A1c measured from vein blood in percent
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

Secondary Outcome Measures

Area under the curve of screening instrument compared to American Diabetes Association criteria
screening accuracy of the instrument reported using graph
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
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
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
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
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
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

Full Information

First Posted
June 20, 2021
Last Updated
July 22, 2021
Sponsor
Gadjah Mada University
Collaborators
Universitas Islam Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04979559
Brief Title
Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
Official Title
Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University
Collaborators
Universitas Islam Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Prediabetic State
Keywords
Telemedicine, Intervention, Screening, Self Care, Primary Health Care

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of two arms: (1) a group that is used mobile health application intervention for screening and early intervention and (2) a group that receive standard care for screening and early intervention from PHCs regular practice.
Masking
ParticipantCare Provider
Masking Description
The participant and care provider in each site are unaware of the group allocation.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mHealth apps
Arm Type
Experimental
Arm Description
The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.
Intervention Type
Device
Intervention Name(s)
Mobile health apps
Intervention Description
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
Primary Outcome Measure Information:
Title
Body weight mean change from baseline
Description
Participants' body weight measured by scales using kilograms (kg) measurement unit
Time Frame
at baseline and after intervention at 12-weeks
Title
Waist circumference mean change from baseline
Description
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
Time Frame
at baseline and after intervention at 12-weeks
Title
Fasting blood glucose mean change from baseline
Description
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
Time Frame
at baseline and after intervention at 12-weeks
Title
Hemoglobin A1c mean change from baseline
Description
Participants' Hemoglobin A1c measured from vein blood in percent
Time Frame
at baseline and after intervention at 12-weeks
Title
Oral glucose tolerance test mean change from baseline
Description
Participants' oral glucose tolerance test measured from vein blood in milligram per deciliter (mg/dL) measurement unit
Time Frame
at baseline and after intervention at 12-weeks
Secondary Outcome Measure Information:
Title
Area under the curve of screening instrument compared to American Diabetes Association criteria
Description
screening accuracy of the instrument reported using graph
Time Frame
immediately after the intervention begin
Title
Sensitivity value of screening instrument compared to American Diabetes Association criteria
Description
Sensitivity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
Time Frame
immediately after the intervention begin
Title
Specificity value of screening instrument compared to American Diabetes Association criteria
Description
Specificity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
Time Frame
immediately after the intervention begin
Title
Positive predictive value of screening instrument compared to American Diabetes Association criteria
Description
Positive predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
Time Frame
immediately after the intervention begin
Title
Negative predictive value of screening instrument compared to American Diabetes Association criteria
Description
Negative predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
Time Frame
immediately after the intervention begin
Title
Accuracy value of screening instrument compared to American Diabetes Association criteria
Description
Accuracy predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
Time Frame
immediately after the intervention begin
Title
Likelihood ratio of screening instrument compared to American Diabetes Association criteria
Description
Likelihood ratio of the instrument calculated using formula derived from 2x2 tables of diagnostic test
Time Frame
immediately after the intervention begin
Other Pre-specified Outcome Measures:
Title
Participant's acceptance of mobile health application
Description
evaluation of participant's acceptance to the device using Mobile Health Application Acceptance Questioner adapted from previous study
Time Frame
after intervention at 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaltafit A Jeem
Phone
+62 856-4366-1294
Email
yaltafit.abror.j@ugm.ac.id
First Name & Middle Initial & Last Name or Official Title & Degree
Russy N Andriani
Phone
+6287821562151
Email
russy.novita@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaltafit A Jeem
Organizational Affiliation
Gadjah Mada University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalasan PHC
City
Sleman
State/Province
Yogyakarta
ZIP/Postal Code
55571
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaltafit A Jeem
Phone
+62 856-4366-1294
Email
yaltafit.abror.j@ugm.ac.id

12. IPD Sharing Statement

Plan to Share IPD
No

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

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