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临床试验/NCT03260335
NCT03260335撤回不适用

A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury

University of Glasgow0 个研究点开始时间: 2017年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Number of incidents of challenging behaviour

研究概览

简要总结

This study aims to explore whether feedback from a physical monitoring device (electronic watch) to prompt patients to use an anxiety management strategy can help prevent challenging behaviour.

详细描述

A multiple baseline "A-B-A" single case experimental design will be adopted with baseline, intervention, and return to baseline phases.

Participants will wear the portable monitoring device with heart rate monitor, pedometer and global positioning system (GPS) functions. A pre-calculated algorithm, developed using machine learning software will be used to predict challenging behaviour episodes 2-4 hours in advance of the event. Recent research has developed a best predictor model with a sensitivity of 82% and specificity of 42%, when averaged across two participants (in press). The device will communicate with a smart phone, via Bluetooth connectivity, when an event has been predicted.

Following enrolment in the study, participants will be randomly assigned to a treatment start time, which will follow from an initial baseline phase. During the baseline phase, participants will wear a commercially available smart watch with physiological monitoring capability, for at least one month in order to gather behaviour frequency data, and associated physiological data; no prompts will be provided. During this period, behavioural and physiological data will be sent to a secure server where a machine learning algorithm will examine the relationships between data streams and 'self-tune' to improve its prediction of challenging behaviour episodes. In the treatment phase, participants and staff will receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart watch/connected mobile phone, when an event has been predicted. This will prompt participants to implement a proactive anxiety management strategy, and will prompt staff to support the participant in completing this, if required. The strategy used will be predetermined in the participant's standard care plan e.g. breathing relaxation, reframing the problem, behavioural redirection. Details will be recorded using an adapted version of the Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in which the biofeedback prompt occurred, participant and staff responses to the biofeedback prompt, and any resulting behaviours, including the occurrence of challenging behaviour. Following the intervention phase, participants will return to a baseline phase for one month, in which no prompts will be provided. Again, details of any challenging behaviour will be recorded via the OAS-MNR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants who have sustained a severe injury to the brain, as determined by length of unconsciousness (greater than 24 hours), a Glasgow Coma Scale of 3 to 8 and a Post Traumatic Amnesia period greater than 1 day
  • participants who are resident in the Graham Anderson House, Brain Injury Rehabilitation (BIRT) Unit
  • participants presenting with challenging behaviour, during the recruitment period
  • participants will NOT be excluded on the basis of comorbid psychiatric disorders or drug/alcohol use, in order to provide conclusions representative of the clinical population
  • participants will NOT be excluded on the basis of being unable to provide informed consent, in order to provide conclusions representative of the clinical population

排除标准

  • a level of cognitive impairment that would prevent individuals from understanding the feedback obtained via digital or verbal prompts
  • participants without the capacity to consent, that do not provide verbal assent to participate in the study

研究组 & 干预措施

Biofeedback intervention

Experimental

Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan

干预措施: Anxiety management strategy (Behavioral)

结局指标

主要结局

Number of incidents of challenging behaviour

时间窗: 5 months

Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)

次要结局

  • Implementation of anxiety management strategy(5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Jon Evans

Professor of Applied Neuropsychology

University of Glasgow

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