Reducing Isolation and Feeling of Loneliness During Critical Illness (SOCIAL)

Reducing Isolation and Loneliness in Patients With Critical Illness With Novel Engagement Strategies: a Pilot Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Depression; Critical Illness; Anxiety; Social Isolation; Post Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Social Engagement

Detailed Description

Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after ICU include underlying systematic illness, as well as consequences of life-saving therapies. In brief, patients are frequently restricted and even restrained to the bed, provided high dosages of sedatives, develop delirium, and are isolated from family and staff for extended periods of time. Moreover, the ICU environment including lights, noises, and the social isolation have a serious negative impact on cognitive function and emotional health status. Prospective data from the ICU demonstrate that critically ill patients in ICU spend two-thirds of their time completely alone.

Patients who have survived describe their ICU experience as a traumatic event similar to war, and testimonials for the ICU Recovery clinic frequently resemble: "I felt like I was being held captive in an unknown basement." Periods of social isolation in daily life as well as in the hospital have a significant negative impact on patient-centered outcomes including increased risk of disability, frailty, and mortality. Our study will examine the feasibility of delivering social engagement interventions using technology such as virtual reality (VR) to reduce feelings of isolation and loneliness. There have been a handful of projects to reduce anxiety and depression using a myriad of delivery techniques including journaling in a diary, emotional-behavioral therapy, face-to-face social engagement and family engagement using face-time and VR. These projects, however, have not examined the impact of social engagement on reducing periods of isolation and loneliness. We hypothesize that social engagement delivered using VR technologies will reduce periods of social isolation and thus improve anxiety, depression, and post-traumatic stress disorder (PTSD).

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • UK Heatlhcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social engagement using VR; 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; 30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support
No Intervention: Control; Control will receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported anxiety	Hospital Anxiety and Depression Scale - Anxiety- self report questionnaire with higher scores indicating worse perceived anxiety	Through study completion, which will occur on average 1-3 months after hospital discharge
Self-reported depression	Hospital Anxiety and Depression Scale - Depression - self report questionnaire with higher scores indicating worse perceived depression	Through study completion, which will occur on average 1-3 months after hospital discharge
Self-reported health related quality of life	EurQol-5Domain (EQ-5D) - self report questionnaire with higher scores indicating better perceived quality of life	Through study completion, which will occur on average 1-3 months after hospital discharge
Cognitive function	Montreal Cognitive Assessment - performed cognitive examination with higher scores indicating better cognitive function	Through study completion, which will occur on average 1-3 months after hospital discharge

Collaborators and Investigators

• Sponsor: Kirby Mayer

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: critical illness; social isolation; Post Intensive Care Unit Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 77702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared via dissemination at national conferences and manuscripts; and available upon request of the primary investigator

Drug and device information, study documents

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