Brain InjuryNCT02913755
Motivation and Self-awareness in Acquired Brain Injury (ABI)
A study testing Preparatory video in people with Brain Injury, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury
- What is being tested?
- Preparatory video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Brain Injury
- Being tested
- Preparatory video
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparatory videoBehavioural
5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Repeated viewing of a short Preparatory video about ABI rehabilitation; viewed every 2-3 days over a 4 week period Receives: Behavioral: Preparatory video |
| Lagged Control Group | Active comparator | 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 Receives: Behavioral: Preparatory video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation for traumatic brain injury rehabilitation
Score from Motivation for traumatic brain injury rehabilitation questionnaire - MOT-Q
Measured: Change from baseline to 4 weeks
Secondary outcomes (5)
Awareness
Score from Awareness Questionnaire - AQ
Measured: Change from baseline to 4 weeks
Behaviour change
Score from Pittsburgh Rehabilitation Participation Scale - PRPS
Measured: Change from baseline to 4 weeks
Feasibility
Score from Structured Assessment of Feasibility measure (SAFE)
Measured: 4 weeks
Feasibility of intervention delivery
Percentage of scheduled videos delivered to each participant
Measured: 4 weeks
Rehabilitation participation
Number of rehabilitation sessions offered/attended/refused
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start7 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Responsible party
- Principal investigator, Hamish J McLeod PhD CPsychol, University of Glasgow
- Investigators
- Hamish McLeod, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913755
- Sponsor's protocol ID
- 16/WS/0232
- Status last verified
- Oct 2017
- First submitted
- 22 Sep 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment Motivation and Self-awareness in People With Moderate to Severe Acquired Brain Injury (ABI)
- ClinicalTrials.gov ID
- NCT02913755
- Acronym / sponsor ID
- 16/WS/0232
- Conditions
- Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Preparatory videoRepeated viewing of a short Preparatory video about ABI rehabilitation; viewed every 2-3 days over a 4 week period |
| Lagged Control Group | Active comparator | Behavioral: Preparatory video2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preparatory video5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation | Behavioural | Intervention group, Lagged Control Group |
Primary outcome
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
5 secondary outcomes
Awareness
Time frame: Change from baseline to 4 weeks
Behaviour change
Time frame: Change from baseline to 4 weeks
Feasibility
Time frame: 4 weeks
Feasibility of intervention delivery
Time frame: 4 weeks
Rehabilitation participation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamish McLeod principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparatory video in people with Brain Injury, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation for traumatic brain injury rehabilitation (time frame: Change from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.