Clinical trial NCT05537311: Reducing Isolation and Feeling of Loneliness During Critical Illness
Official title: Reducing Isolation and Loneliness in Patients With Critical Illness With Novel Engagement Strategies: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Social Isolation
Anxiety
Depression
Post Intensive Care Unit Syndrome
Keywords: critical illness
Post Intensive Care Unit Syndrome
social isolation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot-randomized trial
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of implementing the study intervention
timeFrame: Through completion of the intervention, which on average will occur one week after randomization
measure: Safety of the study intervention defined as number of patients with treatment-related adverse event
timeFrame: Through completion of the intervention, which on average will occur one week after randomization
Secondary outcomes:
measure: Self-reported anxiety
timeFrame: Through study completion, which will occur on average 1-3 months after hospital discharge
measure: Self-reported depression
timeFrame: Through study completion, which will occur on average 1-3 months after hospital discharge
measure: Self-reported health related quality of life
timeFrame: Through study completion, which will occur on average 1-3 months after hospital discharge
measure: Cognitive function
timeFrame: Through study completion, which will occur on average 1-3 months after hospital discharge
Other outcomes:
Locations:
city: Lexington
country: United States
facility: UK Heatlhcare
state: Kentucky
Study officials:
References: