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

Primary Purpose

Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Preparatory video
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brain Injury Rehabilitation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Lagged Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Awareness
Score from Awareness Questionnaire - AQ
Behaviour change
Score from Pittsburgh Rehabilitation Participation Scale - PRPS
Feasibility
Score from Structured Assessment of Feasibility measure (SAFE)
Feasibility of intervention delivery
Percentage of scheduled videos delivered to each participant
Rehabilitation participation
Number of rehabilitation sessions offered/attended/refused

Full Information

First Posted
September 22, 2016
Last Updated
October 26, 2017
Sponsor
University of Glasgow
Collaborators
Brain Injury Rehabilitation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02913755
Brief Title
Motivation and Self-awareness in Acquired Brain Injury (ABI)
Official Title
Improving Treatment Motivation and Self-awareness in People With Moderate to Severe Acquired Brain Injury (ABI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
Brain Injury Rehabilitation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Repeated viewing of a short Preparatory video about ABI rehabilitation; viewed every 2-3 days over a 4 week period
Arm Title
Lagged Control Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Preparatory video
Intervention Description
5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation
Primary Outcome Measure Information:
Title
Motivation for traumatic brain injury rehabilitation
Description
Score from Motivation for traumatic brain injury rehabilitation questionnaire - MOT-Q
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Awareness
Description
Score from Awareness Questionnaire - AQ
Time Frame
Change from baseline to 4 weeks
Title
Behaviour change
Description
Score from Pittsburgh Rehabilitation Participation Scale - PRPS
Time Frame
Change from baseline to 4 weeks
Title
Feasibility
Description
Score from Structured Assessment of Feasibility measure (SAFE)
Time Frame
4 weeks
Title
Feasibility of intervention delivery
Description
Percentage of scheduled videos delivered to each participant
Time Frame
4 weeks
Title
Rehabilitation participation
Description
Number of rehabilitation sessions offered/attended/refused
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamish McLeod
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Injury Rehabilitation Trust
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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