Reducing Isolation and Feeling of Loneliness During Critical Illness

Depression Clinical Trial

— SOCIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537311
• Other study ID #: 77702
• Status: Completed
• Phase: N/A
• Start date: July 27, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Critical Illness
• Depression
• Post Intensive Care Unit Syndrome
• Social Isolation

Intervention

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

Locations

Country	Name	City	State
United States	UK Heatlhcare	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Mayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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