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OpenTrials
Completed

NCT Number: NCT05537311

Reducing Isolation and Feeling of Loneliness During Critical Illness

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UK Heatlhcare

Lexington, Kentucky, 40536, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Engagement

Behavioral

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

Primary outcomes

  1. Feasibility of implementing the study intervention

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

    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).

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

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

    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.

Secondary outcomes

  1. Self-reported anxiety

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

    Hospital Anxiety and Depression Scale - Anxiety- self report questionnaire with higher scores indicating worse perceived anxiety

  2. Self-reported depression

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

    Hospital Anxiety and Depression Scale - Depression - self report questionnaire with higher scores indicating worse perceived depression

  3. Self-reported health related quality of life

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

    EurQol-5Domain (EQ-5D) - self report questionnaire with higher scores indicating better perceived quality of life

  4. Cognitive function

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

    Montreal Cognitive Assessment - performed cognitive examination with higher scores indicating better cognitive function

Sponsors and collaborators

Lead sponsor

Kirby Mayer

Other

Registry information

Official study title

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

Acronym: SOCIAL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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