Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02516982
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-07-20
Brief Title:
mHealth for Antenatal Mental Health
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study
Status:
COMPLETED
Status Verified Date:
2019-09
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:
AMHS
Brief Summary:
The aim of this study is to determine the feasibility of using mobile technology for
1 Implementing the recommendations of the Antenatal and postnatal mental health clinical management and service guidance NICE guideline for recognising depression ie Whooley questions followed by a validated screening instrument such as the Edinburgh Postnatal Depression Scale during pregnancy using iPad Air tablets in the waiting area of general practices midwifery services or hospitals during antenatal clinics and
2 Using a bespoke app running on pregnant womens own smartphones to monitor mood and symptoms of depression throughout pregnancy
1 Implementing the recommendations of the Antenatal and postnatal mental health clinical management and service guidance NICE guideline for recognising depression ie Whooley questions followed by a validated screening instrument such as the Edinburgh Postnatal Depression Scale during pregnancy using iPad Air tablets in the waiting area of general practices midwifery services or hospitals during antenatal clinics and
2 Using a bespoke app running on pregnant womens own smartphones to monitor mood and symptoms of depression throughout pregnancy
Detailed Description:
As part of our first aim we will assess the psychometric properties of the Whooley questions by comparing the answers given to these questions against the scores obtained on the Edinburgh Postnatal Depression Scale and we will manipulate the survey questionnaire layout of the Whooley Questions and the Edinburgh Postnatal Depression Scale in order to ensure that this survey design choice does not affect data quality As part of our second aim we will compare two prospective sampling protocols on patient compliance and engagement with the app
We will use a parallel randomised control trial study design Participation in each part of the study ie iPads in antenatal clinics or app running on own handset will be independent from each other Those participants consenting to get involved in the part of the study assessing the use of iPads in antenatal clinics will be randomly assigned to complete i an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a scrolling layout ie App screening - Scrolling or ii an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a paging layout ie App screening - Paging
Participants consenting to get involved in the part of the study assessing the use of an app running on participants own devices will be randomly allocated to one of two sampling protocols i a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale and 5 momentary questions related to mood or ii a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale
We will utilise a block randomisation procedure with blocks of 4 to generate our allocation sequence Random numbers will be generated using Stata 130 Researchers conducting participant recruitment will not be involved in this randomisation procedure in order to avoid recruitment bias
We will use a parallel randomised control trial study design Participation in each part of the study ie iPads in antenatal clinics or app running on own handset will be independent from each other Those participants consenting to get involved in the part of the study assessing the use of iPads in antenatal clinics will be randomly assigned to complete i an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a scrolling layout ie App screening - Scrolling or ii an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a paging layout ie App screening - Paging
Participants consenting to get involved in the part of the study assessing the use of an app running on participants own devices will be randomly allocated to one of two sampling protocols i a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale and 5 momentary questions related to mood or ii a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale
We will utilise a block randomisation procedure with blocks of 4 to generate our allocation sequence Random numbers will be generated using Stata 130 Researchers conducting participant recruitment will not be involved in this randomisation procedure in order to avoid recruitment bias
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None