The objective of this study is to determine what the differences are between care as usual and care where a seizure detection device is used in addition to care as usual. Specifically, this study will compare the number of missed and correct visits…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this research is to investigate the effect of seizure
detection devices on the number of valid and missed visits by caregivers to
clients following an alarm.
Secondary outcome
Secondary parameters are the effect of seizure detection devices on quality of
life (both general and disease specific), number of complications after 12
months and user experience of both healthcare workers and patients.
Furthermore, specifically designed cost questionnaires will be designed based
on the latest HTA-insights, in order to perform a cost-utility and
cost-effectiveness analysis of the intervention.
Due to randomized allocation of the two seizure detection devices, there will
be data available regarding possible differences between these two devices.
Even though this is not a part of the primary goal of this study, these data
will be analyzed in order to determine whether there are differences between
the two devices.
Background summary
In around one in three epilepsy patients, seizures cannot be properly
controlled with anti-seizure medication. Having continued seizures can lead to
serious complications such as injuries or status epilepticus. Having seizures
during the night increases the risk of sudden unexpected death in epilepsy. On
top of that, healthcare costs related to, among other, complications and
societal costs for the group with continued epileptic seizures are high (>3000
euro per patient per year).
Study objective
The objective of this study is to determine what the differences are between
care as usual and care where a seizure detection device is used in addition to
care as usual. Specifically, this study will compare the number of missed and
correct visits from healthcare workers after an epileptic seizure, as well as
cost-effectiveness, quality of life, user experience and number of
complications.
Study design
This study was designed as a pre-post study in which an intervention will take
place after a baseline period.
Intervention
After a baseline period of three months, participants will start wearing a
seizure detection device with medical CE (either NightWatch or Epi-Care Free)
during the night.
Study burden and risks
Participants will not have to undergo any extra tests or visit any research
locations because the study will be done at the healthcare facility where
participants live. The cost questionnaires and one of the user experience
questionnaires will be filled out by healthcare workers. Participants will fill
out questionnaires themselves (with help if necessary) at four different
timepoints. Three times, participants will fill out a general quality of life
questionnaire (EQ-5D-5L or EuroQol by Proxy) and a disease specific quality of
life questionnaire (QOLIE-31-P). Furthermore, participants will fill out a user
experience questionnaire twice. If needed, questionnaires can be filled out by,
or with the help of, someone close to the participant. The risk for
participants of this study are negligible.
Benefit for the participants in this study is that they will be able to use a
seizure detection device for 12 months, which will likely reduce the number of
night-time epileptic seizures missed by healthcare workers. This reduces the
chance of (serious) complications these seizures can cause. If the outcomes of
this study are positive (such as fewer missed seizures and positive user
experiences among caregivers), the results of this study could contribute to
healthcare institutions' decisions to start using seizure detection devices.
This could help reduce the risks of missed night-time epileptic seizures across
the entire population. Since the study focuses on the cost-effectiveness of
seizure detection tools in healthcare settings and the number of valid and
missed visits by healthcare workers, it is not feasible to conduct this
research in a different population.
Sterkselseweg 65
Heeze 5591 VE
NL
Sterkselseweg 65
Heeze 5591 VE
NL
Listed location countries
Age
Inclusion criteria
At least 18 years old
Living in a Dutch long-term care facility
At least 1 suspected major, night-time epileptic seizure that requires medical
assistance per month (this includes tonic-clonic seizures, tonic seizures
longer than 30 seconds and/or hypermotor seizures)
Willing to wear a seizure detection device
No objection to video monitoring during the study
Sufficient proficiency in the Dutch language to fill out the required
questionnaires (with assistance if needed)
Exclusion criteria
Already has adequate seizure detection available
Will start using a seizure detection device within 3 months or less
Has a movement disorder that manifests during the night
Design
Recruitment
Medical products/devices used
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 | NL86903.015.24 |