A Biofeedback Intervention for the Prevention of Challenging Behaviour

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03260335
• Other study ID #: 17/SS/0119
• Status: Withdrawn
• Phase: N/A
• First received: August 21, 2017
• Last updated: March 26, 2018
• Start date: November 2017
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Intervention

Behavioral:
• Anxiety management strategy
Anxiety management strategy as per standard care plan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Brain Injury Rehabilitation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incidents of challenging behaviour	Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)	5 months
Secondary	Implementation of anxiety management strategy	Number of times anxiety management strategy successfully employed	5 months