Virtual Visitation in Intensive Care Unit Study (ISEEU)

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.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill Patients
• Intervention / Treatment: Behavioral: Virtual meeting between patients/physicians and caregiver

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung-Young Oh; Phone Number: +82-2-2072-3538; Email: faun1226@gmail.com

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual visitation group; Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day	Behavioral: Virtual meeting between patients/physicians and caregiver; Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day
No Intervention: Control group; Phone interview between physicians-caregivers once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2105-188-1224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No