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Virtual Visitation in Intensive Care Unit Study (ISEEU)

Primary Purpose

Critically Ill Patients

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual meeting between patients/physicians and caregiver
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Virtual visitation group

Control group

Arm Description

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

Phone interview between physicians-caregivers once a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2021
Last Updated
October 12, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04962204
Brief Title
Virtual Visitation in Intensive Care Unit Study
Acronym
ISEEU
Official Title
Efficacy of Virtual Visitation in Intensive Care Unit During COVID-19 Pandemic: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional group Control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual visitation group
Arm Type
Active Comparator
Arm Description
Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Phone interview between physicians-caregivers once a day
Intervention Type
Behavioral
Intervention Name(s)
Virtual meeting between patients/physicians and caregiver
Intervention Description
Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day
Primary Outcome Measure Information:
Title
FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled
Description
The FS-ICU survey score reflected the satisfaction degree of caregivers. The overall satisfaction score is derived from questions 1 through 24.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients who discharge or die within 48 hours of admission to ICU
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Young Oh
Phone
+82-2-2072-3538
Email
faun1226@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seoul National University Hospital

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Virtual Visitation in Intensive Care Unit Study

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