To assess patient satisfaction of antenatal care perceived by (vulnerable) pregnant women and explore the user experience by (vulnerable) pregnant women and HCPs (healthcare professionals working in antenatal care) while using the app for real time…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is a comparison of patient satisfaction between the
intervention and control group, measured at 18-22 weeks of gestation (baseline)
and at 35-37 weeks of gestation using the Pregnancy and Childbirth
Questionnaire (PCQ).
Secondary outcome
Secondary parameters include an exploration of the usability and user
experience, measured by means of customized quantitative and qualitative
questions as well as the System Usability Scale (SUS), for the pregnant women
in the intervention group at 28-29 and 35-37 weeks of gestation and for HCPs
using the basic dashboard to be sent out 4 months after the start of the
study and at the end of the study.
In addition, a retrospective analysis of the PRFS risk flagging functionality
will be conducted.
Finally, an analysis on satisfaction and user experience for a subgroup of
vulnerable women (retrospectively identified by using the R4U questionnaire)
versus not-vulnerable women will be performed. This will also be done for the
women in primary care only, in secondary care only and referred during
pregnancy.
Background summary
Pregnant women seem to find it hard to distinguish physiological changes during
pregnancy from pathological symptoms indicating a potential pregnancy
complication. Early detection of a pregnancy complication may prevent or
decrease the risk of adverse maternal and neonatal outcomes. Vulnerable women
are particularly at risk of adverse outcomes during the perinatal period due to
multiple factors. There is a need to provide pregnant women with reliable
information and advice regarding physiological and pathological symptoms and
when to contact a healthcare professional (HCP).
We have developed a prototype for real time patient monitoring of pregnant
women, as RPM (remote patient monitoring) is still lacking in the area of
antenatal care. The Pregnancy Risk Flagging System (PRFS) consists of a mobile
application (app) called for pregnant women to
self-report symptoms and parameters as blood pressure and foetal kick count.
Leveraging this technology for antenatal care could contribute to higher
patient satisfaction by enabling increased personal care and by assisting
earlier identification of potential pregnancy risks which may occur between ANC
visits, because of real time monitoring. This, in turn, could have the
potential to improve maternal and neonatal outcomes. Specifically, vulnerable
pregnant women could benefit from this technology as they make suboptimal use
of the current healthcare system. However, in order to implement this system in
daily practice, user experience and risk flagging functionality must be
examined first.
Study objective
To assess patient satisfaction of antenatal care perceived by (vulnerable)
pregnant women and explore the user experience by (vulnerable) pregnant women
and HCPs (healthcare professionals working in antenatal care) while using the
app for real time symptom reporting, in addition to
regular antenatal care. Furthermore, the risk flagging functionality of this
system will be examined retrospectively.
Study design
Multicenter, randomized controlled trial.
Intervention
Use of app by pregnant women to report their pregnancy
symptoms in addition to the regular antenatal care. During the antenatal care
visit (ANC visit), the HCP has access to a symptoms-overview of the pregnant
woman in the PRFS basic dashboard prototype and this will be discussed between
the pregnant woman and HCP. The control group of pregnant women will use
regular antenatal care.
Study burden and risks
The PRFS will not interfere with regular antenatal care, since the risk
flagging will be done asynchronous. Hence the study yields low risk for the
pregnant woman, foetus or HCP. Pregnant women need to make time to report their
symptoms in the app and to fill in the questionnaires.
HCPs need to make time to discuss pregnant woman*s reported symptoms with them
during ANC visits and to fill in the questionnaires.
HCPs and pregnant women of the intervention group may benefit from improved
communication and more personalised care. Furthermore, the PRFS is a promising
tool in addition to regular antenatal care. It may improve the experience of
antenatal care for (vulnerable) pregnant women and HCPs and, in the future, it
may improve earlier detection of pregnancy risks than a scheduled ANC visit,
thus contributing to the prevention or early treatment of complications.
High Tech Campus 52
Eindhoven 5656 AG
NL
High Tech Campus 52
Eindhoven 5656 AG
NL
Listed location countries
Inclusion criteria
· Pregnant women with a viable pregnancy
· 18 years or older
· Able to read and understand English and/or Dutch language
· Have smartphone and internet access
o iPhone: at least iPhone 7, running the latest iOS version that is on the
market at the date of
starting the study
o Android: not older than 5 years old phone running at least Android 6.0
· Willing and able to provide informed consent
· Woman expects to be available during entire study follow-up (meaning, she has
no plans to travel or move in near future during her pregnancy)
Exclusion criteria
· Anomalous findings of foetus at the 20 weeks ultrasound scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75365.015.20 |
| Other | NTR NL8872 |