Critically Ill PatientsISEEUNCT04962204
Virtual Visitation in Intensive Care Unit Study
A study testing Virtual meeting between patients/physicians and caregiver in people with Critically Ill Patients, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Virtual meeting between patients/physicians and caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are expected to stay in the intensive care unit for more than 48 hours
- Patients with a RASS score of -2 or higher
Who cannot join
- Patients who discharge or die within 48 hours of admission to ICU
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Seoul National University Hospital
About this study
Official title: Efficacy of Virtual Visitation in Intensive Care Unit During COVID-19 Pandemic: Randomized Controlled Trial
The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic.
Read the detailed description
After being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (Virtual visitation once a day) or Control group (Phone interviews once a day).
- Conditions
- Critically Ill Patients
- Being tested
- Virtual meeting between patients/physicians and caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual meeting between patients/physicians and caregiverBehavioural
Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day
| Study group | Role | What they receive |
|---|---|---|
| Virtual visitation group | Active comparator | Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day Receives: Behavioral: Virtual meeting between patients/physicians and caregiver |
| Control group | No intervention | Phone interview between physicians-caregivers once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled
The FS-ICU survey score reflected the satisfaction degree of caregivers. The overall satisfaction score is derived from questions 1 through 24.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start6 Jul 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional group Control group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Young Oh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962204
- Sponsor's protocol ID
- 2105-188-1224
- Acronym
- ISEEU
- Status last verified
- Oct 2021
- First submitted
- 5 Jul 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Woo HY, Oh SY, Lim L, Im H, Lee H, Ha EJ, Ryu HG. Efficacy of Virtual Visitation in ICU During COVID-19 Pandemic: The ICU Visits Randomized Controlled Trial. Crit Care Med. 2024 Dec 1;52(12):e593-e603. doi: 10.1097/CCM.0000000000006429. Epub 2024 Sep 16.
PubMed 39283178
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Visitation in Intensive Care Unit During COVID-19 Pandemic: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04962204
- Acronym / sponsor ID
- ISEEU / 2105-188-1224
- Conditions
- Critically Ill Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic.
Detailed description
After being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (Virtual visitation once a day) or Control group (Phone interviews once a day).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional group Control group
| Arm | Type | Receives |
|---|---|---|
| Virtual visitation group | Active comparator | Behavioral: Virtual meeting between patients/physicians and caregiverVirtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day |
| Control group | No intervention | –Phone interview between physicians-caregivers once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are expected to stay in the intensive care unit for more than 48 hours
- Patients with a RASS score of -2 or higher
Key exclusion criteria (1 listed)
- Patients who discharge or die within 48 hours of admission to ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual meeting between patients/physicians and caregiverVirtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day | Behavioural | Virtual visitation group |
Primary outcome
FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled
Time frame: 7 days
The FS-ICU survey score reflected the satisfaction degree of caregivers. The overall satisfaction score is derived from questions 1 through 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 39283178Woo HY, Oh SY, Lim L, Im H, Lee H, Ha EJ, Ryu HG. Efficacy of Virtual Visitation in ICU During COVID-19 Pandemic: The ICU Visits Randomized Controlled Trial. Crit Care Med. 2024 Dec 1;52(12):e593-e603. doi: 10.1097/CCM.0000000000006429. Epub 2024 Sep 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual meeting between patients/physicians and caregiver in people with Critically Ill Patients, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Young Oh (+82-2-2072-3538, faun1226@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.