The primary objective is to determine the effect of ICU-VR at three months after discharge on psychological sequelae and HRQoL up to 6 months after discharge in patients treated for COVID-19 on the ICU. The secondary objective is to determine the…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
psychische klachten na IC opname, kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the effect of ICU-VR after three months on the severity
and occurrence of psychological sequelae and the HRQoL in ICU patients treated
for COVID-19 up to 6 months after discharge.
Secondary outcome
The secondary endpoint is the effect of ICU-VR after six months on the severity
and occurrence of psychological sequelae and the HRQoL in ICU patients treated
for COVID-19 up to 12 months after discharge.
Background summary
The SARS-CoV-2 outbreak has resulted in a tremendous increase of Intensive Care
Unit (ICU) admissions all over the world. Due to the long ICU stay and amount
of mechanical ventilation, these patients are at risk for developing several
psychological impairments, such as posttraumatic stress disorder (PTSD),
anxiety and depression. These sequelae are part of the post-intensive care
syndrome (PICS) and will adversely impact their health-related quality of life
(HRQoL). An effective treatment strategy for these psychological PICS-related
sequelae is still lacking.
In a recent ICU specific Virtual Reality (ICU-VR) study in sepsis patients we
demonstrated that ICU-VR is safe, easy applicable and decreased PTSD and
depression in sepsis survivors. We therefore want to study if ICU-VR has
similar effects in COVID-19 patients.
Study objective
The primary objective is to determine the effect of ICU-VR at three months
after discharge on psychological sequelae and HRQoL up to 6 months after
discharge in patients treated for COVID-19 on the ICU. The secondary objective
is to determine the effect of ICU-VR at six months after discharge on
psychological sequelae and HRQoL up to 12 months after discharge.
Study design
A multicentre randomized controlled trial in four hospitals in Rotterdam. The
study will be conducted in the Erasmus MC (an academic hospital), the
Franciscus Gasthuis & Vlietland (teaching hospital), the Ikazia Hospital
(teaching hospital) and the Maasstad hospital (teaching hospital).
Intervention
All patients will be invited to a post-COVID outpatient clinic at six weeks,
three months and six months after discharge as part of care as usual. During
the first visitation at six weeks of prior to the second visitation at three
months after discharge, patients will be informed about the study. During the
second visitation patients will be included and thereafter randomized into two
study groups:
1) Group A: Patients in this group will receive ICU-VR once during the 3-month
visitation to the post-COVID outpatient clinic.
2) Group B: Patients in this group will receive ICU-VR once during the 6-month
visitation to the post-COVID outpatient clinic.
Additionally, patients receive questionnaires prior to the post-COVID
outpatient clinic visitations, 1 month after receiving ICU-VR and 12 months
after discharge.
Study burden and risks
No additional burden is expected. ICU-VR is proven safe and feasible. No safety
issues or adverse events have been reported using ICU specific VR nor in other
studies using VR. In addition the questionnaire that is used is already
validated and used in multiple clinical studies.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
* * 18 years old
* A positive SARS-CoV-2 PCR with clinical signs of COVID-19 necessitating ICU
care
* Able to understand the Dutch language
* Signed informed-consent
Exclusion criteria
* Documented active, established psychiatric disease (for instance personality
disorders or schizophrenia)
* Admitted with or a history of a primary neurological impairment necessitating
ICU admission to or discharge of the ICU (patients admitted with traumatic
brain injury, CVA, stroke, meningitis). Patients with a medical history of
delirium are eligible, if symptoms of delirium are not present at the time of
inclusion.
* Lack of formal home address
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL73667.078.20 |
| OMON | NL-OMON20934 |