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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.
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Scientific title
Prevalence of a history of acquired brain injury in South Australian prisoners and significance of this for prisoners and prison system
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Secondary ID [1]
289538
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
BIRP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury
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Condition category
Condition code
Neurological
299260
299260
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0
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Other neurological disorders
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Injuries and Accidents
299318
299318
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
295130
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Not applicable
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Comparator / control treatment
NA
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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At admissions health assessment
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Primary outcome [2]
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Frontal Systems Behaviour Scale
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Assessment method [2]
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Timepoint [2]
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Within 3 days after admission to the prison
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Primary outcome [3]
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Neurobehavioural inventory
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Assessment method [3]
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Timepoint [3]
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Within 3 days after admission to the prison
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Secondary outcome [1]
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Information about prisoner incidents
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Assessment method [1]
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Timepoint [1]
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12 weeks following admission to prison or prior to their discharge from prison (if earlier than 12 weeks)
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Eligibility
Key inclusion criteria
Prisoners on the day of their admission to prison (not transfers from other prisons)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Prisoners who are being transferred from another prison
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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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).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
7/07/2016
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Actual
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Date of last participant enrolment
Anticipated
28/06/2018
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Actual
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Date of last data collection
Anticipated
3/08/2018
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Actual
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Sample size
Target
414
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
6051
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
13500
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Hampstead Rehabilitation Centre, Royal Adelaide Hospital, South Australia Brain Injury Rehabilitation Services
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Address [1]
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Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield South Australia 5085
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Country [1]
293913
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Australia
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Primary sponsor type
Hospital
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Name
Hampstead Rehabilitation Centre, Royal Adelaide Hospital, South Australia Brain Injury Rehabilitation Services
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Address
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
292785
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Adelaide Local Health Network Royal Adelaide Hospital Human Research and Ethics Committee
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Ethics committee address [1]
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Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/05/2015
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Approval date [1]
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26/10/2015
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Ethics approval number [1]
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HREC/15/RAH/183
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Summary
Brief summary
A number of studies have reported a high prevalance of people with an acquired brain injury are incarcerated in prisons throughout the world. This study will investigate the prevalence of prisoners in SA prisons who have a history of traumatic or non traumatic brain injury from incident, stroke or substance abuse. This prevalence study forms phase 1 of the trial. Phase 2 of the trial will investigate the neurobehavioural sequelae of those who have experienced an ABI. Phase 3 will involve a qualitative investigation with prisoners being interviewed about their experiences in prison, and preparing to leave prison to manage in the community.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
939
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/AnzctrAttachments/370964-Ethics approval Letter_Killington-signed_2015_06_02.pdf
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Contacts
Principal investigator
Name
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Dr Maggie Killington
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Address
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SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
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Country
66914
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Australia
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Phone
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+6 1 400061204
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Maggie Killington
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Address
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SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
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Country
66915
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Australia
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Phone
66915
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+6 1 400061204
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Fax
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Email
66915
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[email protected]
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Contact person for scientific queries
Name
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Dr Maggie Killington
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Address
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SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
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Country
66916
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Australia
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Phone
66916
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+6 1 400061204
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Fax
66916
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Email
66916
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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