Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829252
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-03-06
Brief Title:
Testing the Feasibility of a Novel Growth Monitoring Smartphone App
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Testing the Feasibility of a Novel Growth Monitoring Smartphone App
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test the acceptability feasibility accuracy and precision of the GrowthMonitor smartphone app in a pilot population
Detailed Description:
The GrowthMonitor app will calculate height data using smartphone images of children taken by parents or carers in the home at two or more set time points The app will convert height data from the image to a numerical height measurement in centimeters and this will be transferred to a central database hosted on a secure UK based server with additional relevant demographic data gender ethnicity weight date of birth and parents height
The height and demographic data are transferred with an anonymous identifier to a GDPR-approved secure database on a UK based server Critically patient images and childrens names will not be transferred and only authorized users will have access to the data stored within the secure database
The app will display a virtual growth chart providing the patient with a digital history of the childs growth over time BMI will also be calculated and plotted on an age- and gender-appropriate chart Ultimately users of the app will need to create an account using a username email address and password We will use their email address so that password resets can be sent along with reminders or alerts about their account
Childs height in relation to hisher parental heights as well as longitudinal growth data will be analyzed within the secure UK based web server using existing growth monitoring algorithms
1 Height compared to population-based height references HSDS
2 Distance from target height calculated from parental heights THSDSDEV
3 HSDS change over time ΔHSDS -when more than one height measurement is available taken 6 months apart
Recorded heights will be compared with pre-established cut-off standards that define normal growth in an appropriate population We envisage being able to incorporate ethnicity-matched reference population data as the app evolves An automated outcome will be returned to the parentcarer via in app notification or email and will offer advice for example confirming normal growth or recommending appropriate medical contact
Data will be stored in such a way that users can sync their old growth measurements on to any new replacement smartphone handset and also sync any measurements taken offline
An accurate standing height measurement will be obtained using a calibrated stadiometer during a patient clinic visit This gold standard height measurement will be performed by a trained member of the research team and documented This will be used to compare with the height obtained by the growth monitoring app in the clinic and subsequently at home
The height and demographic data are transferred with an anonymous identifier to a GDPR-approved secure database on a UK based server Critically patient images and childrens names will not be transferred and only authorized users will have access to the data stored within the secure database
The app will display a virtual growth chart providing the patient with a digital history of the childs growth over time BMI will also be calculated and plotted on an age- and gender-appropriate chart Ultimately users of the app will need to create an account using a username email address and password We will use their email address so that password resets can be sent along with reminders or alerts about their account
Childs height in relation to hisher parental heights as well as longitudinal growth data will be analyzed within the secure UK based web server using existing growth monitoring algorithms
1 Height compared to population-based height references HSDS
2 Distance from target height calculated from parental heights THSDSDEV
3 HSDS change over time ΔHSDS -when more than one height measurement is available taken 6 months apart
Recorded heights will be compared with pre-established cut-off standards that define normal growth in an appropriate population We envisage being able to incorporate ethnicity-matched reference population data as the app evolves An automated outcome will be returned to the parentcarer via in app notification or email and will offer advice for example confirming normal growth or recommending appropriate medical contact
Data will be stored in such a way that users can sync their old growth measurements on to any new replacement smartphone handset and also sync any measurements taken offline
An accurate standing height measurement will be obtained using a calibrated stadiometer during a patient clinic visit This gold standard height measurement will be performed by a trained member of the research team and documented This will be used to compare with the height obtained by the growth monitoring app in the clinic and subsequently at home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None