NCT04962204

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

July 5, 2021

Last Update Submit

October 12, 2021

Conditions

Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Study Arms (2)

Virtual visitation group

ACTIVE COMPARATOR

Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day

Behavioral: Virtual meeting between patients/physicians and caregiver

Control group

NO INTERVENTION

Phone interview between physicians-caregivers once a day

Interventions

Virtual meeting between patients/physicians and caregiverBEHAVIORAL

Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day

Virtual visitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who discharge or die within 48 hours of admission to ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39283178DERIVED

MeSH Terms

Interventions

PhysiciansCaregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Central Study Contacts

Seung-Young Oh

CONTACT

+82-2-2072-3538faun1226@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Interventional group Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Profeessor

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 14, 2021

Study Start

July 6, 2021

Primary Completion

March 31, 2022

Study Completion

June 30, 2022

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

KR(1)