Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000780752
Ethics application status
Approved
Date submitted
3/05/2022
Date registered
1/06/2022
Date last updated
1/06/2022
Date data sharing statement initially provided
1/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of community participation outcomes for adults with acquired brain injury after discharge from post-acute rehabilitation: A mixed-methods study
Scientific title
Investigation of community participation outcomes for adults with acquired brain injury after discharge from post-acute rehabilitation: A mixed-methods study
Secondary ID [1] 306722 0
None
Universal Trial Number (UTN)
U1111-1276-0507
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 325703 0
Condition category
Condition code
Neurological 323051 323051 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Site: The Brightwater ‘Oats Street’ Facility is an acquired brain injury rehabilitation facility that is based on a novel model of care called Staged-Community-Based-Brain Injury Rehabilitation. Community Participation is the ability of a person to participate in activities outside of the home environment.
A prospective longitudinal cohort study design will be used.
Community participation outcomes for Oats Street clients will be measured at four time points: At discharge (T0) and at 4 months (T1), 8 months (T2) and 12 months (T3) following discharge.
Sample size calculation: Based on client discharge numbers from 2018-2020, we expect approximately 26 (range: 20-31) discharges per year, or 52 (range: 40-62) discharges over the 24-month study follow-up period. Factoring in an expected response/attrition rate of 20% based on similar studies in the literature, the total number of participants expected to fully complete the study is 41 (range: 32-50).
After study enrolment, participants will be assessed at four time points over the study period: T0 (1-2 weeks prior to discharge), T1 (4 months), T2 (8 months) and T3 (12 months) post-discharge. At each time point, assessments will include administration of 1) core outcome measures: The Community Integration Questionnaire to measure community participation (approximate time commitment of 15 minutes), The UK Functional Independence Measure and Functional Assessment Measure (approximate time commitment of 35 minutes) as well as the Mayo-Portland Adaptability Inventory (approximate time commitment of 15 minutes) to measure functional independence and aspects of community participation, the Goal Attainment Scale (approximate time commitment of 30 minutes) to measure goal attainment related to community participation and the Quality of Life after Brain Injury instrument (approximate time commitment of 10 minutes) to measure quality of life; 2) any additional outcome measures identified in a previous phase of the study and 3) the structured survey developed in the previous phase of the study (approximate time commitment of 20 minutes). These will all be conducted with each participant during multiple 60 minute face-to-face sessions over a one-week period.
Discharge (T0)
Discharge assessments will take place at Oats Street 1-2 weeks prior to discharge. The core outcome measures will be completed by Oats Street staff members. Additional outcome measures identified from the systematic review and the structured survey will be completed by the researcher. The researcher was employed as an Occupational Therapist at Oats Street for 6 months in 2020, however it is unlikely that they will be known to participants unless there was some interaction during this period of employment.
Follow-Ups (T1-T3)
Follow-up assessments will be conducted over one week at the participant’s home. If the participant’s home is not suitable, they will be able to choose a location suitable to them. To reduce participant fatigue, assessments will be completed during multiple 60-minute meetings over the one-week period. All assessments will be completed by the researcher. The researcher will implement participant retention strategies to reduce attrition over the follow-up period. Participants will be contacted one month before each time point to prepare suitable times for assessment via phone and email. Once the dates have been confirmed, a reminder text and email will be sent two weeks before the start date. The researcher will maintain regular contact with participants throughout the follow-up period via phone and email.
A series of multilevel mixed effect regression models will be used to analyse changes in community participation outcomes and to develop and test a community participation explanatory model.
Intervention code [1] 323170 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330813 0
Community Participation: Mean Community Integration Questionnaire Score (CIQ)
Timepoint [1] 330813 0
Baseline (1-2 weeks prior to discharge), four months, eight months and twelve months after discharge.
Primary outcome [2] 331467 0
Community Participation: Answers from Community Participation Survey (developed specifically for this research project).
Timepoint [2] 331467 0
Baseline (1-2 weeks prior to discharge), four months, eight months and twelve months after discharge.
Secondary outcome [1] 407691 0
Functional Independence: Mean UK Functional Independence Measure and Functional Assessment Measure Score (UK FIM+FAM)
Timepoint [1] 407691 0
Baseline (1-2 weeks prior to discharge), four months, eight months and twelve months after discharge.
Secondary outcome [2] 407692 0
Goal Attainment: Mean Goal Attainment Scale Score (GAS).
Timepoint [2] 407692 0
Baseline (1-2 weeks prior to discharge), four months, eight months and twelve months after discharge.
Secondary outcome [3] 407693 0
Quality of Life: Mean Quality of Life after Brain Injury Score (QoLIBRI).
Timepoint [3] 407693 0
Baseline (1-2 weeks prior to discharge), four months, eight months and twelve months after discharge.
Secondary outcome [4] 410002 0
Functional Independence: Mean Mayo-Portland Adaptability Inventory Score (MPAI-4).
Timepoint [4] 410002 0
Baseline (1-2 weeks prior to discharge), four months, eight months and twelve months after discharge.

Eligibility
Key inclusion criteria
Brightwater Oats Street Clients will be eligible for participation if they have: 1) completed rehabilitation at Brightwater Oats Street with a minimum length of stay of 6 months, 2) commenced discharge planning, and 3) are able to communicate in basic English. Clients must be aged between 18-65 to participate in the Oats Street program as this is a Department of Health funding requirement.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Brightwater Oats Street Clients will be excluded if they do not have the capacity to consent or have a legal guardian who can provide informed consent on their behalf.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data Analysis
Statistical analysis will be completed using the Statistical Package for the Social Sciences (SPSS) Version 22.0. Descriptive statistics (mean, median, standard deviation, and range) will be calculated to summarise baseline demographic and clinical characteristics, length of rehabilitation stay, and time since discharge. Raw outcome measure scores will be adjusted to normative units utilising normative data published in peer-reviewed studies for each outcome measure for analysis.
A series of multi-level mixed effects regression models will be used to analyse any statistically significant change in community participation outcomes at T1, T2 and T3 after discharge from Brightwater Oats Street.
Clinically significant changes in outcomes will be examined according to the Minimal Clinically Important Difference (MCID) recommended in published standard studies for each outcome measure. Explanatory Modelling: Lastly, three multi-level mixed effects regression models will be used to evaluate predictors of community participation (CIQ total score) at T1, T2 and T3 after discharge from Brightwater Oats Street.
Predictor variables will include demographic variables (e.g., age, gender, marital status), clinical variables (e.g., ABI diagnosis, time since injury, length of stay, time since discharge), outcome measures (e.g., UK FIM+FAM, MPAI-4, GAS, QoLIBRI), and other key variables identified (e.g., level of funding, level of social support).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
41
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22310 0
Brightwater Oats Street Rehabilitation Facility - East Victoria Park
Recruitment postcode(s) [1] 37098 0
6101 - East Victoria Park

Funding & Sponsors
Funding source category [1] 311053 0
University
Name [1] 311053 0
Curtin University
Country [1] 311053 0
Australia
Funding source category [2] 311055 0
Other Collaborative groups
Name [2] 311055 0
Brightwater Care Group
Country [2] 311055 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street, Bentley, Western Australia 6102.
Country
Australia
Secondary sponsor category [1] 312383 0
Individual
Name [1] 312383 0
Lily Cullinan
Address [1] 312383 0
Curtin University of Technology: Kent Street, Bentley, Western Australia 6102.
Country [1] 312383 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310599 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 310599 0
Ethics committee country [1] 310599 0
Australia
Date submitted for ethics approval [1] 310599 0
11/01/2022
Approval date [1] 310599 0
07/03/2022
Ethics approval number [1] 310599 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118214 0
Miss Lily Cullinan
Address 118214 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102
Country 118214 0
Australia
Phone 118214 0
+61417966960
Fax 118214 0
Email 118214 0
[email protected]
Contact person for public queries
Name 118215 0
Lily Cullinan
Address 118215 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102
Country 118215 0
Australia
Phone 118215 0
+61417966960
Fax 118215 0
Email 118215 0
[email protected]
Contact person for scientific queries
Name 118216 0
Lily Cullinan
Address 118216 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102
Country 118216 0
Australia
Phone 118216 0
+61417966960
Fax 118216 0
Email 118216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.