NCT04979559

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

June 20, 2021

Last Update Submit

July 22, 2021

Conditions

PreDiabetesPrediabetic State

Keywords

TelemedicineInterventionScreeningSelf CarePrimary Health Care

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (7)

  • Area under the curve of screening instrument compared to American Diabetes Association criteria

    immediately after the intervention begin

  • Sensitivity value of screening instrument compared to American Diabetes Association criteria

    immediately after the intervention begin

  • Specificity value of screening instrument compared to American Diabetes Association criteria

    immediately after the intervention begin

  • Positive predictive value of screening instrument compared to American Diabetes Association criteria

    immediately after the intervention begin

  • Negative predictive value of screening instrument compared to American Diabetes Association criteria

    immediately after the intervention begin

  • +2 more secondary outcomes

Other Outcomes (1)

  • Participant's acceptance of mobile health application

    after intervention at 12-weeks

Study Arms (2)

mHealth apps

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Other: Standard care

Interventions

Mobile health appsDEVICE

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

mHealth apps
Standard careOTHER

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

Standard care

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • severe medical condition
  • disability to perform physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalasan PHC

Sleman, Special Region of Yogyakarta, 55571, Indonesia

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Yaltafit A Jeem

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaltafit A Jeem

CONTACT

+62 856-4366-1294yaltafit.abror.j@ugm.ac.id

Russy N Andriani

CONTACT

+6287821562151russy.novita@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The participant and care provider in each site are unaware of the group allocation.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 28, 2021

Study Start

May 25, 2021

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)