NCT02913755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 7, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

September 22, 2016

Last Update Submit

October 26, 2017

Conditions

Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Motivation for traumatic brain injury rehabilitation

    Score from Motivation for traumatic brain injury rehabilitation questionnaire - MOT-Q

    Change from baseline to 4 weeks

Secondary Outcomes (5)

  • Awareness

    Change from baseline to 4 weeks

  • Behaviour change

    Change from baseline to 4 weeks

  • Feasibility

    4 weeks

  • Feasibility of intervention delivery

    4 weeks

  • Rehabilitation participation

    4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Repeated viewing of a short Preparatory video about ABI rehabilitation; viewed every 2-3 days over a 4 week period

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

Behavioral: Preparatory video

Interventions

Preparatory videoBEHAVIORAL

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

Intervention groupLagged Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Injury Rehabilitation Trust

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Hamish McLeod

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

April 7, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)