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Trial registered on ANZCTR


Registration number
ACTRN12616000869471
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
4/07/2016
Date last updated
4/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Injury Research in Prisons (BIRP): Prevalence of a history of acquired brain injury in South Australian prisoners and evaluation of behavioural impacts.
Scientific title
Prevalence of a history of acquired brain injury in South Australian prisoners and significance of this for prisoners and prison system
Secondary ID [1] 289538 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BIRP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 299248 0
Condition category
Condition code
Neurological 299260 299260 0 0
Other neurological disorders
Injuries and Accidents 299318 299318 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase 1. Prevalence study. Data will be collected by prison health nurses conducting the admitting health assessments. A semi-structured interview format will be used to ask about past incidences and risk factors for acquired brain injury. This will form part of their health assessment.
Phase 2. Observational study
Prisoners who are evaluated as having a history of ABI (fulfilled at least one or more risk factors) will be invited to meet with the nurse manager to complete 3 questionaires which is estimated will take approximately 30 minutes. The Frontal Systems Behaviour Scale and Neurobehavioural Investory will assess behavioural characteristics of participants. The demographic questionaire will ask questions about their medical and psychiatric history as well as their educational background.
Phase 3: Qualitative investigation. 10 -15 prisoners will be invited to attend an interview with the Chief Investigator, an experienced interviewer to seek their perceptions on their experiences within the prison system, and any issues they have about returning to the community.
Intervention code [1] 295130 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298739 0
Presence of risk factors for history of acquired brain injury will be assessed by semi-structured interview within the initial health assessment.
ASSAULT with LOC for longer than 30 minutes
MOTOR VEHICLE ACCIDENT with LOC longer than 30 minutes
AMATEUR/PROFESSIONAL BOXING KNOCKED OUT with LOC longer than 30 minutes
DIAGNOSIS OF STROKE
DIAGNOSIS OF BRAIN INJURY OR HEAD INJURY
SELF HARM INCIDENT with LOC longer than 30 minutes
ALCOHOL CONSUMPTION
MALE: 6 STANDARD DRINKS/day for longer than 8 years
FEMALE: 3 STANDARD DRINKS/day for longer than 8 years
DRUG USE
1.for longer than 8 years OR
DRUG OVERDOSE
2. An overdose requiring resuscitation OR
3. An overdose with LOC for longer than 30 minutes OR
4. An overdose requiring hospitalisation greater than 1 day
Timepoint [1] 298739 0
At admissions health assessment
Primary outcome [2] 298740 0
Frontal Systems Behaviour Scale
Timepoint [2] 298740 0
Within 3 days after admission to the prison
Primary outcome [3] 298742 0
Neurobehavioural inventory
Timepoint [3] 298742 0
Within 3 days after admission to the prison
Secondary outcome [1] 325250 0
Information about prisoner incidents
Timepoint [1] 325250 0
12 weeks following admission to prison or prior to their discharge from prison (if earlier than 12 weeks)

Eligibility
Key inclusion criteria
Prisoners on the day of their admission to prison (not transfers from other prisons)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prisoners who are being transferred from another prison

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Prevalence Study Phase 1.
As the aim of the prevalence study is to determine an adequate sample size to estimate the population prevalence of prisoners with an ABI with a good precision we have considered a number of parameters in establishing a reasonable sample size.
1. The expected prevalence. We know from other studies that numbers quoted have varied between 25% to 87%. By estimating a 50 % prevalence for this current study, we have ensured that we calculate the highest sample size.
2. Precision. If the prevalence is expected to be between 10-90%, a precision of 5% with a smaller error of estimate is recommended (Naing L et al 2006).
3. Expected number of non responders. It is recommended to oversample by 10% to 20% of the computed sample size number to achieve the desired precision.

Our estimated sample size calculation with assumptions of 5% precision, 50 % prevalence and a population size of 3302 people admitted into the prison system each year, resulted in n=345 with 95% confidence interval between the specified limits of 45% -55%. If we are to include an additional 20% of respondents, the new target is n= 414.
Frequency estimates will be determined, including confidence levels calculated to inform the likelihood of the unobserved target group falling within a certain range of the observed sample value.
2. Neurobehavioural Investigation Phase 2
Descriptive statistics will be used. The two subgroups (traumatic and non-traumatic brain injury) will be analysed and compared.
3. Qualitative Investigation Phase 3
Thematic analysis using nVivo10 .Thematic analysis of the interview data will be undertaken where patterns are looked for and sorted into categories by two independent researchers (Patton 1990). Once the patterns, linkages and explanations have been decided, the researchers will look for rival or competing themes and explanations. This may occur inductively by looking for different ways to organize the data that might lead to different findings, or logically by thinking of other logical possibilities and then investigating whether those possibilities are supported by the data (Patton 1990).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2016
Actual
Date of last participant enrolment
Anticipated
28/06/2018
Actual
Date of last data collection
Anticipated
3/08/2018
Actual
Sample size
Target
414
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6051 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 13500 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293913 0
Hospital
Name [1] 293913 0
Hampstead Rehabilitation Centre, Royal Adelaide Hospital, South Australia Brain Injury Rehabilitation Services
Country [1] 293913 0
Australia
Primary sponsor type
Hospital
Name
Hampstead Rehabilitation Centre, Royal Adelaide Hospital, South Australia Brain Injury Rehabilitation Services
Address
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country
Australia
Secondary sponsor category [1] 292785 0
None
Name [1] 292785 0
Address [1] 292785 0
Country [1] 292785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295340 0
Central Adelaide Local Health Network Royal Adelaide Hospital Human Research and Ethics Committee
Ethics committee address [1] 295340 0
Ethics committee country [1] 295340 0
Australia
Date submitted for ethics approval [1] 295340 0
28/05/2015
Approval date [1] 295340 0
26/10/2015
Ethics approval number [1] 295340 0
HREC/15/RAH/183

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 939 939 0 0
/AnzctrAttachments/370964-Ethics approval Letter_Killington-signed_2015_06_02.pdf

Contacts
Principal investigator
Name 66914 0
Dr Maggie Killington
Address 66914 0
SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country 66914 0
Australia
Phone 66914 0
+6 1 400061204
Fax 66914 0
Email 66914 0
[email protected]
Contact person for public queries
Name 66915 0
Maggie Killington
Address 66915 0
SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country 66915 0
Australia
Phone 66915 0
+6 1 400061204
Fax 66915 0
Email 66915 0
[email protected]
Contact person for scientific queries
Name 66916 0
Maggie Killington
Address 66916 0
SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country 66916 0
Australia
Phone 66916 0
+6 1 400061204
Fax 66916 0
Email 66916 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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