NCT05537311

Brief Summary

The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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 27, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 27, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

July 27, 2022

Last Update Submit

July 13, 2023

Conditions

Critical IllnessSocial IsolationAnxietyDepressionPost Intensive Care Unit Syndrome

Keywords

critical illnessPost Intensive Care Unit Syndromesocial isolation

Outcome Measures

Primary Outcomes (2)

  • Feasibility of implementing the study intervention

    Determine the number of sessions delivered per number of sessions scheduled. The study sample size of 12 subjects to receive the intervention, and each subject in the intervention should receive 5 sessions each = 60 sessions total; success will be considered 75% of sessions delivered (45 sessions completed of 60 planned).

    Through completion of the intervention, which on average will occur one week after randomization

  • Safety of the study intervention defined as number of patients with treatment-related adverse event

    Minor adverse events, major adverse events, and unanticipated problems as assessed by the investigators per study protocol will be recorded during each treatment session. The rate of adverse events will be examined.

    Through completion of the intervention, which on average will occur one week after randomization

Secondary Outcomes (4)

  • Self-reported anxiety

    Through study completion, which will occur on average 1-3 months after hospital discharge

  • Self-reported depression

    Through study completion, which will occur on average 1-3 months after hospital discharge

  • Self-reported health related quality of life

    Through study completion, which will occur on average 1-3 months after hospital discharge

  • Cognitive function

    Through study completion, which will occur on average 1-3 months after hospital discharge

Study Arms (2)

Social engagement using VR

EXPERIMENTAL

Patients will receive social engagement with emphasize on meaningful conversation, cognitive engagement, and emotional support provided by trained research assistant using virtual reality as a vehicle for delivery. Subjects will receive 15-45 minutes of treatment per day for 5 days initiated after respiratory support (Intubation via mask or tube, high-flow nasal cannula) have been weaned to nasal cannula. Experimental group will also receive standard of care

Behavioral: Social Engagement

Control

NO INTERVENTION

Control will receive standard of care

Interventions

Social EngagementBEHAVIORAL

30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support

Social engagement using VR

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • admitted to ICU with acute respiratory failure (ventilation via tube or mask or HFNC)

You may not qualify if:

  • previous cognitive or emotional health condition
  • inability to follow commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UK Heatlhcare

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Critical IllnessSocial IsolationAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehaviorMental DisordersBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to treatment group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: pilot-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2022

First Posted

September 13, 2022

Study Start

July 27, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

US(1)