PreDiabetesNCT04979559
Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
A study testing Mobile health apps in people with PreDiabetes and Prediabetic State, run by Gadjah Mada University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- PreDiabetes, Prediabetic State
- What is being tested?
- Mobile health apps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 May 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- severe medical condition
- disability to perform physical activity
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Kalasan PHC
Sleman, Special Region of Yogyakarta, 55571
Yaltafit A Jeem, +62 856-4366-1294, yaltafit.abror.j@ugm.ac.id
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes, Prediabetic State
- Being tested
- Mobile health apps, Standard care
- Keywords
- Telemedicine, Intervention, Screening, Self Care, Primary Health Care
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health appsDevice
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
Standard careOther
Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight mean change from baseline
Participants' body weight measured by scales using kilograms (kg) measurement unit
Measured: 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
Measured: 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
Measured: at baseline and after intervention at 12-weeks
Hemoglobin A1c mean change from baseline
Participants' Hemoglobin A1c measured from vein blood in percent
Measured: 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
Measured: at baseline and after intervention at 12-weeks
Secondary outcomes (7)
Area under the curve of screening instrument compared to American Diabetes Association criteria
screening accuracy of the instrument reported using graph
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately after the intervention begin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start25 May 2021
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Islam Indonesia
- Responsible party
- Principal investigator, Yaltafit Abror Jeem, Gadjah Mada University
- Investigators
- Yaltafit A Jeem, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979559
- Sponsor's protocol ID
- KE/FK/1375/EC/2020
- Status last verified
- Jul 2021
- First submitted
- 20 Jun 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study
- ClinicalTrials.gov ID
- NCT04979559
- Acronym / sponsor ID
- KE/FK/1375/EC/2020
- Conditions
- PreDiabetes, Prediabetic State
- Keywords
- Telemedicine, Intervention, Screening, Self Care, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Universitas Islam Indonesia
- Study start
- 25 May 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mHealth apps | Experimental | Device: Mobile health appsThe participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states. |
| Standard care | Active comparator | Other: Standard careThe participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- severe medical condition
- disability to perform physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health appsMobile health application intervention including screening and early intervention such as diet and physical activity suggestion | Device | mHealth apps |
| Standard careRegular practice for screening and early intervention for prediabetes patient in primary health cares setting | Other | Standard care |
Primary outcome
Body weight mean change from baseline
Time frame: at baseline and after intervention at 12-weeks
Participants' body weight measured by scales using kilograms (kg) measurement unit
Waist circumference mean change from baseline
Time frame: at baseline and after intervention at 12-weeks
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
Fasting blood glucose mean change from baseline
Time frame: at baseline and after intervention at 12-weeks
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
Hemoglobin A1c mean change from baseline
Time frame: at baseline and after intervention at 12-weeks
Participants' Hemoglobin A1c measured from vein blood in percent
Oral glucose tolerance test mean change from baseline
Time frame: at baseline and after intervention at 12-weeks
Participants' oral glucose tolerance test measured from vein blood in milligram per deciliter (mg/dL) measurement unit
7 secondary outcomes
Area under the curve of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Sensitivity value of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Specificity value of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Positive predictive value of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Negative predictive value of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Accuracy value of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Likelihood ratio of screening instrument compared to American Diabetes Association criteria
Time frame: immediately after the intervention begin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaltafit A Jeem principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health apps in people with PreDiabetes and Prediabetic State, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaltafit A Jeem (+62 856-4366-1294, yaltafit.abror.j@ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight mean change from baseline (time frame: at baseline and after intervention at 12-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.