- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02913755
Motivation and Self-awareness in Acquired Brain Injury (ABI)
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Glasgow, United Kingdom
- Brain Injury Rehabilitation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Repeated viewing of a short Preparatory video about ABI rehabilitation; viewed every 2-3 days over a 4 week period
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5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation
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Active Comparator: Lagged Control Group
2 week period of treatment as usual followed by repeated viewing of a short Preparatory video about ABI rehabilitation; viewed every 2-3 days over a 4 week period
|
5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation for traumatic brain injury rehabilitation
Time Frame: Change from baseline to 4 weeks
|
Score from Motivation for traumatic brain injury rehabilitation questionnaire - MOT-Q
|
Change from baseline to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Awareness
Time Frame: Change from baseline to 4 weeks
|
Score from Awareness Questionnaire - AQ
|
Change from baseline to 4 weeks
|
Behaviour change
Time Frame: Change from baseline to 4 weeks
|
Score from Pittsburgh Rehabilitation Participation Scale - PRPS
|
Change from baseline to 4 weeks
|
Feasibility
Time Frame: 4 weeks
|
Score from Structured Assessment of Feasibility measure (SAFE)
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4 weeks
|
Feasibility of intervention delivery
Time Frame: 4 weeks
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Percentage of scheduled videos delivered to each participant
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4 weeks
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Rehabilitation participation
Time Frame: 4 weeks
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Number of rehabilitation sessions offered/attended/refused
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4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hamish McLeod, University of Glasgow
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/WS/0232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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