Motivation and Self-awareness in Acquired Brain Injury (ABI)

Brain Injury Clinical Trial

Official title:

Improving Treatment Motivation and Self-awareness in People With Moderate to Severe Acquired Brain Injury (ABI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913755
• Other study ID #: 16/WS/0232
• Status: Completed
• Phase: N/A
• First received: September 22, 2016
• Last updated: October 26, 2017
• Start date: April 7, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 groups; 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• current inpatients with moderate-severe ABI (i.e. damage to the brain's physiology caused by an external force or pathophysical damage resulting from non-degenerative organic factors such as stroke, encephalitis, aneurysm, neurological disease)

• aged >18 years

• capacity to give consent

Exclusion Criteria:

• communication difficulties that might affect ability to consent to or understand/comply with test procedures

• severe mental illness or challenging behaviour that would prevent meaningful participation in the study

• a discharge date within the trial period

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Preparatory video
5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation

Locations

Country	Name	City	State
United Kingdom	Brain Injury Rehabilitation Trust	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Brain Injury Rehabilitation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motivation for traumatic brain injury rehabilitation	Score from Motivation for traumatic brain injury rehabilitation questionnaire - MOT-Q	Change from baseline to 4 weeks
Secondary	Awareness	Score from Awareness Questionnaire - AQ	Change from baseline to 4 weeks
Secondary	Behaviour change	Score from Pittsburgh Rehabilitation Participation Scale - PRPS	Change from baseline to 4 weeks
Secondary	Feasibility	Score from Structured Assessment of Feasibility measure (SAFE)	4 weeks
Secondary	Feasibility of intervention delivery	Percentage of scheduled videos delivered to each participant	4 weeks
Secondary	Rehabilitation participation	Number of rehabilitation sessions offered/attended/refused	4 weeks