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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913755
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Brain Injury Rehabilitation Trust
Information provided by (Responsible Party):
Hamish J McLeod PhD CPsychol, University of Glasgow

Brief 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.


Condition or disease Intervention/treatment Phase
Brain Injury Behavioral: Preparatory video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Treatment Motivation and Self-awareness in People With Moderate to Severe Acquired Brain Injury (ABI)
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Awareness [ Time Frame: Change from baseline to 4 weeks ]
    Score from Awareness Questionnaire - AQ

  2. Behaviour change [ Time Frame: Change from baseline to 4 weeks ]
    Score from Pittsburgh Rehabilitation Participation Scale - PRPS

  3. Feasibility [ Time Frame: 4 weeks ]
    Score from Structured Assessment of Feasibility measure (SAFE)

  4. Feasibility of intervention delivery [ Time Frame: 4 weeks ]
    Percentage of scheduled videos delivered to each participant

  5. Rehabilitation participation [ Time Frame: 4 weeks ]
    Number of rehabilitation sessions offered/attended/refused



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913755


Locations
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United Kingdom
Brain Injury Rehabilitation Trust
Glasgow, United Kingdom
Sponsors and Collaborators
University of Glasgow
Brain Injury Rehabilitation Trust
Investigators
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Principal Investigator: Hamish McLeod University of Glasgow
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Responsible Party: Hamish J McLeod PhD CPsychol, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT02913755    
Other Study ID Numbers: 16/WS/0232
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System