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A Biofeedback Intervention for the Prevention of Challenging Behaviour

Primary Purpose

Acquired Brain Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anxiety management strategy
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acquired Brain Injury focused on measuring Challenging behaviour, Biofeedback, Anxiety management

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Biofeedback intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Number of incidents of challenging behaviour
    Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)

    Secondary Outcome Measures

    Implementation of anxiety management strategy
    Number of times anxiety management strategy successfully employed

    Full Information

    First Posted
    August 21, 2017
    Last Updated
    March 26, 2018
    Sponsor
    University of Glasgow
    Collaborators
    Brain Injury Rehabilitation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03260335
    Brief Title
    A Biofeedback Intervention for the Prevention of Challenging Behaviour
    Official Title
    A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Favourable ethical opinion not obtained
    Study Start Date
    November 2017 (Anticipated)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Glasgow
    Collaborators
    Brain Injury Rehabilitation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acquired Brain Injury
    Keywords
    Challenging behaviour, Biofeedback, Anxiety management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Biofeedback intervention
    Arm Type
    Experimental
    Arm Description
    Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
    Intervention Type
    Behavioral
    Intervention Name(s)
    Anxiety management strategy
    Intervention Description
    Anxiety management strategy as per standard care plan
    Primary Outcome Measure Information:
    Title
    Number of incidents of challenging behaviour
    Description
    Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Implementation of anxiety management strategy
    Description
    Number of times anxiety management strategy successfully employed
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Evans, BSc PhD
    Organizational Affiliation
    University of Glasgow
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Biofeedback Intervention for the Prevention of Challenging Behaviour

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