Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000805774
Ethics application status
Approved
Date submitted
24/05/2022
Date registered
8/06/2022
Date last updated
8/06/2022
Date data sharing statement initially provided
8/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors influencing community participation outcomes for adults who have sustained an acquired brain injury: A scoping review
Scientific title
What factors influence community participation outcomes for adults who have sustained an acquired brain injury?
Secondary ID [1] 307197 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 326424 0
Condition category
Condition code
Neurological 323705 323705 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
This study will be looking at factors influencing community participation for adults with acquired brain injury living in the community. Community Participation is the ability of a person to participate in activities outside of the home environment. There are three Parts to this study. Part 1 will involve a scoping review to identify factors influencing community participation. Part 2 will involve semi-structured interviews (anticipated duration of 45-60 minutes) of adults with acquired brain injury who have been discharged from a community-based residential rehabilitation facility (Brightwater Oats Street or 'Oats Street') and are now living in their homes. Each participant will attend one interview. Interviews will take place face-to-face at a location convenient to the participant, preferably at the participant's home (with the exception of staff members who will be interviewed at Oats Street). Their family members or carers and Oats Street staff members will also be interviewed. Findings from the scoping review will be used to develop the interview questions for these interviews. Questions will be designed to ask participants about their experiences related to the key factors identified in the scoping review and any other factors that may also influence community participation outcomes for adults with acquired brain injury. Part 3 will involve research protocol development for a subsequent study (ACTRN12622000780752). Findings from the scoping review and interviews will be utilised to select and develop key outcome measures for this subsequent study. This will include the design of a structured quantitative survey.
Intervention code [1] 323644 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331451 0
Factors influencing Community Participation: Face-to-face, one-on-one, 45-60 minute semi-structured interviews that will be audio-recorded with a dictaphone developed specifically for this research project will be undertaken with previous Oats Street clients of previous Oats Street clients.
Timepoint [1] 331451 0
Interviews will be conducted with participants at a date and time convenient to them.
Primary outcome [2] 331548 0
Factors influencing Community Participation: Face-to-face, one-on-one, 45-60 minute semi-structured interviews that will be audio-recorded with a dictaphone developed specifically for this research project will be undertaken with family members and/or carers.
Timepoint [2] 331548 0
Interviews will be conducted with participants at a date and time convenient to them.
Primary outcome [3] 331551 0
Factors influencing Community Participation: Face-to-face, one-on-one, 45-60 minute semi-structured interviews that will be audio-recorded with a dictaphone developed specifically for this research project will be undertaken with Oats Street staff members.
Timepoint [3] 331551 0
Interviews will be conducted with participants at a date and time convenient to them.
Secondary outcome [1] 409941 0
Experience of Community Participation: Face-to-face, one-on-one, 45-60 minute semi-structured interviews that will be audio-recorded with a dictaphone developed specifically for this research project will be undertaken with previous Oats Street clients.
Timepoint [1] 409941 0
Interviews will be conducted with participants at a date and time convenient to them.
Secondary outcome [2] 410238 0
Experience of Community Participation: Face-to-face, one-on-one, 45-60 minute semi-structured interviews that will be audio-recorded with a dictaphone developed specifically for this research project will be undertaken with family members and/or carers
Timepoint [2] 410238 0
Interviews will be conducted with participants at a date and time convenient to them.
Secondary outcome [3] 410239 0
Experience of Community Participation: Face-to-face, one-on-one, 45-60 minute semi-structured interviews that will be audio-recorded with a dictaphone developed specifically for this research project will be undertaken with Oats Street staff members.
Timepoint [3] 410239 0
Interviews will be conducted with participants at a date and time convenient to them.

Eligibility
Key inclusion criteria
Clients: Oats Street discharge records will be used to identify eligible participants. Eligible participants will be individuals who have: 1) completed Staged Community-Based Based Brain Injury Rehabilitation (SCBIR) at Oats Street with a minimum length of stay of 6 months, 2) been discharged for at least 3 months, and 3) are able to communicate in basic conversational English.
Family: Clients and/or their legal guardians will provide consent for the researcher to contact family member/s and carers by email. Family members aged 18 years and older will be included if they have regular contact with the client. Carers who have worked with the client at least once per week for more than 3 months will be invited to participate if the client does not have an eligible family member.
Staff: Oats Street staff members including Rehabilitation Coordinators, Occupational Therapists, Physiotherapists, Speech Pathologists, Social Workers, and Community Integration Coordinators (whose role is to assist clients with organising formal and informal supports, prepare housing applications and liaise with other agencies during the discharge process) who have been employed for at least 6 months will be invited via email to participate in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not have capacity to consent or do not have a legal guardian who can provide informed consent on their behalf.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A thematic analysis approach will be undertaken following the six-phase procedure defined by Braun and Clarke to identify and understand the most relevant themes from the interviews. NVivo 12 qualitative data analysis software will be used to manage and code interview transcriptions. Patterns among the codes will be identified and then used to develop preliminary themes. These themes will be shared with all interviewees and the Consumer Reference Group to obtain their input. Themes will be clearly defined to accurately reflect the dataset. A thorough audit trail will be maintained throughout the coding process to ensure consistency between data and the overall findings. Member checking will be conducted throughout this process to first clarify transcripts and then preliminary findings. A formal peer-review process will be completed by the research team to improve the dependability of the research findings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/06/2022
Actual
Date of last participant enrolment
Anticipated
25/07/2022
Actual
Date of last data collection
Anticipated
25/07/2022
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311502 0
University
Name [1] 311502 0
Curtin University of Technology
Country [1] 311502 0
Australia
Funding source category [2] 311509 0
Other Collaborative groups
Name [2] 311509 0
Brightwater Care Group
Country [2] 311509 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street, Bentley, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 312902 0
Individual
Name [1] 312902 0
Lily Cullinan
Address [1] 312902 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102
Country [1] 312902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310964 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 310964 0
Ethics committee country [1] 310964 0
Australia
Date submitted for ethics approval [1] 310964 0
11/01/2022
Approval date [1] 310964 0
07/03/2022
Ethics approval number [1] 310964 0

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

Contacts
Principal investigator
Name 119514 0
Miss Lily Cullinan
Address 119514 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102.
Country 119514 0
Australia
Phone 119514 0
+61417966960
Fax 119514 0
Email 119514 0
lily.cullinan@postgrad.curtin.edu.au
Contact person for public queries
Name 119515 0
Lily Cullinan
Address 119515 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102.
Country 119515 0
Australia
Phone 119515 0
+61417966960
Fax 119515 0
Email 119515 0
lily.cullinan@postgrad.curtin.edu.au
Contact person for scientific queries
Name 119516 0
Lily Cullinan
Address 119516 0
Name: Curtin University of Technology
Address: Kent Street, Bentley, Western Australia 6102.
Country 119516 0
Australia
Phone 119516 0
+61417966960
Fax 119516 0
Email 119516 0
lily.cullinan@postgrad.curtin.edu.au

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.