Skip to main content
OpenTrials
Completed

NCT Number: NCT02913755

Motivation and Self-awareness in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Injury Rehabilitation Trust

Glasgow, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preparatory video

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • Brain Injury Rehabilitation Trust

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.