跳至主要内容
临床试验/NCT05537311
NCT05537311已完成不适用

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

Kirby Mayer2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Safety of the study intervention defined as number of patients with treatment-related adverse event

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor will be blinded to treatment group

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

Feasibility of implementing the study intervention

时间窗: 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).

次要结局

  • Cognitive function(Through study completion, which will occur on average 1-3 months after hospital discharge)
  • 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)

研究者

发起方
Kirby Mayer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kirby Mayer

Assistant Professor

University of Kentucky

研究点 (2)

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