Brain Injury Clinical Trial
Official title:
Improving Treatment Motivation and Self-awareness in People With Moderate to Severe Acquired Brain Injury (ABI)
Acquired Brain Injury (ABI) is damage to the brain caused by a head injury or illness/disease
such as stroke or aneurysm. ABI is often associated with poor awareness into ongoing symptoms
of damage to the brain, which can be cognitive, physical, and psychological. A
multi-disciplinary rehabilitation programme is recommended to help with such symptoms.
However, without self-awareness of difficulties, people with ABI can have poor motivation to
take part. The study aims to discover whether showing people a short 'preparatory' video
about ABI rehabilitation has an effect on self-awareness, and their motivation to take part
in rehabilitation offered to them.
The study also aims to investigate the feasibility of using the preparatory video on a larger
scale across inpatient ABI rehabilitation, by exploring whether staff find delivering the
video easy to incorporate into routine practice.
People invited to take part in the study will be recruited from a specialist inpatient brain
injury rehabilitation unit (BIRT).
People who are approached will be given information about what the study will involve, and
can choose not to take part.
Each participant will be asked to fill out a series of questionnaires. They will then be
supported by staff to watch a short video every two/three days, over four weeks. Half of the
participants will be shown the video right away, while the other half will wait two weeks, to
allow for comparisons between the groups. The video will aim to improve understanding of the
kinds of emotional and/or practical difficulties they may be experiencing, and will inform
participants about what rehabilitation might be like. After they have regularly watched the
video for four weeks both sets of participants will be asked to complete another set of
questionnaires, and the staff will be asked to complete an evaluation of how they found
delivering the video.
The study will be a repeated-measures design, with a lagged control group, allowing within-
and between-subjects analysis. The primary outcome variable is motivation for rehabilitation
(Motivation for traumatic brain injury rehabilitation questionnaire - MOT-Q). Secondary
measures include measures of awareness (Awareness Questionnaire - AQ) and behaviour change
(The Pittsburgh Rehabilitation Participation Scale - PRPS, and participation statistics).
Tertiary outcomes are the assessment of the feasibility of the preparatory material as an
intervention, completed by BIRT staff (Structured Assessment of Feasibility measure - SAFE).
Primary participants will be recruited from a brain injury inpatient unit in Glasgow provided
by Brain Injury Rehabilitation Trust (BIRT), and information recorded from case notes. This
will include demographics, information about the brain injury, a cognitive profile, and
participation statistics relating to attendance in their BIRT rehabilitation programme.
Primary and secondary outcome measures (MOT-Q, AQ) will be completed.
Participants will then be randomly stratified (by time since admission, and motivation for
rehabilitation) into two groupsÍž intervention and control. All participants will view the
preparatory video in a 1:1 delivery by a member of BIRT staff every 2-3 days over a period of
4 weeks, with the control group on delayed exposure of 2 weeks. During the delay period, the
control group will continue to receive routine care from BIRT rehabilitation staff. BIRT
staff will record the number of videos scheduled and watched by each participant.
Primary and secondary outcome measures (MOT-Q, AQ) will be completed by inpatient
participants again mid- and post-trial to allow exploration of effects by within-group
comparisons, and between-group comparison with control group.
Staff participants will complete the AQ and PRPS pre- and post-trial. Routine participation
statistics recorded by staff will be gathered pre- and post-trial. Additionally, staff will
evaluate of the feasibility of delivering the protocol, by completing the SAFE questionnaire
post-trial.
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