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Trial registered on ANZCTR
Registration number
ACTRN12624000904572
Ethics application status
Approved
Date submitted
5/07/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Caring for Caregivers: An Antenatal Wellbeing Program
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Scientific title
Caring for Caregivers: Evaluating the Acceptability and Feasibility of Implementation of an Evidence-Informed Program to Support Caregiver Wellbeing in Antenatal Services
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Secondary ID [1]
312470
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Nil known
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Universal Trial Number (UTN)
U1111-1310-2825
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Caregiver mental health
334315
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Caregiver wellbeing
334439
0
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Caregiver social support
334440
0
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Caregiver self-care
334441
0
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Condition category
Condition code
Mental Health
330968
330968
0
0
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Depression
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Mental Health
330969
330969
0
0
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Anxiety
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Mental Health
330970
330970
0
0
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Other mental health disorders
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Public Health
330971
330971
0
0
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Health promotion/education
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Public Health
330972
330972
0
0
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Health service research
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Reproductive Health and Childbirth
331065
331065
0
0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Caring for Caregivers Trial is a feasibility proof-of-concept pre- and post-trial evaluating the feasibility, acceptability, and effectiveness of a caregiver wellbeing program delivered by Child and Family Health Services (CaFHS) in South Australia.
The caregiver wellbeing program was codesigned and developed in 2023. This was achieved through undertaking three activities: 1) a service review where we mapped existing services available within CaFHS, 2) focus groups with 25 caregivers who have access CaFHS services and 9 CaFHS service providers, and 3) a scoping review examining 70 evidence-informed programs and interventions that support caregiver wellbeing and self-care. Through triangulating the results of these three activities and working closely with CaFHS leadership, consumer researchers, and the CaFHS consumer advisory committee, we used the Intervention Mapping Methodology to develop a caregiver wellbeing program that is relevant, feasible and evidence-informed that could be implemented by CaFHS.
This content will be delivered by CaFHS within antenatal classes delivered at the Women’s and Children’s Hospital (WCH). The WCH offer a suite of antenatal classes to caregivers and the caregiver wellbeing program will be offered over a 2-month period as an optional class. The caregiver wellbeing program class will be delivered by the CaFHS project manager (a registered nurse and midwife) and all caregivers enrolled into one of these classes will receive the evidence-informed caregiver wellbeing program.
The caregiver wellbeing program comprises of approximately 2 hours of content that is structured with a powerpoint presentation and focuses primarily on delivering evidence-informed psychoeducation and facilitation group discussions. Overall the program covers 6 objectives. The objectives are:
1. Introduction to Child and Family Health Service (CaFHS)
2. Understanding Mental Health, Parenting and Seeking Support
3. Discussing Norms, Expectations, and Individualised Experience
4. Navigating Relationships and Social Connections
5. Empowering Self-Worth and Self-Care Strategies
6. Providing Support for Accessing Services and Seeking Help
The project manager will monitor fidelity through a project specific fidelity checklist to track if all 6 objectives are achieved in the class. The project manager will also write reflections in a research journal after each class to keep qualitative notes relating to time spent on each objective, observations regarding participant responses to the content, any ad hoc adaptations to content due to participant engagement, etc.
To further understand the feasibility and fidelity of implementation and acceptability of the caregiver wellbeing program, focus groups will be conducted with approximately 10-15 caregivers who received the intervention and 10-15 CaFHS and WCH staff involved in implementation. Participants will be selected as the first 15 to opt-in. Focus groups will be with approximately 5-10 participants and will be conducted by the Flinders University research team (lead researcher and research assistants) and the discussion will focus on 1) the impact of the program on mental health and wellbeing, 2) what was liked or disliked about the content, 3) if there are any concerns regarding the content or how it was delivered, 4) if they would like any modifications to the content or how it was delivered. Specifically, staff will additionally be asked 1) how well the content and the delivery integrates into routine services, 2) if there were any challenges to delivery or implementation, and 3) perspectives on whether the program would work in other hospitals or settings.
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Intervention code [1]
328989
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Prevention
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Intervention code [2]
328990
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Lifestyle
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Intervention code [3]
328991
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Behaviour
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
338734
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Determine Feasibility to deliver the caregiver wellbeing program within routine care
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Assessment method [1]
338734
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Measured using fidelity, staff, and caregiver outcomes. The project manager will keep notes on topics covered in each session and any concerns with fidelity and delivery of the caregiver wellbeing content. Attendance data via a project specific post-program survey and de-identified routinely collected data provided by Women’s and Children’s Hospital. Additionally, staff and caregiver outcomes will be measured via semi-structured focus groups to assess the feasibility of the program through discussion of content recall and topics.
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Timepoint [1]
338734
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Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
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Primary outcome [2]
338735
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Determine Acceptability of the caregiver wellbeing program
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Assessment method [2]
338735
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Measured using Likert scale questions provided to caregivers in the project specific post-program survey and semi-structured focus groups with caregivers who participated in the antenatal classes and CaFHS/WCH staff working at the intervention site or involved in implementation during the active trial period. Acceptability of CaFHS will be measured Likert scale questions provided to caregivers in the post-program survey and de-identified routinely collected administration data. De-identified summary of participants engagement with CaFHS services (e.g. have they booked into: 1) health and development check or 2) consultation). This data will be shared with the project team to analyse CaFHS service engagement post-antenatal classes.
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Timepoint [2]
338735
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Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
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Secondary outcome [1]
437240
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Mental health
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Assessment method [1]
437240
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The following validated, self-report measure will be administered at two time points at the intervention site and used to measure effectiveness of the program on mental health: DASS-21
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Timepoint [1]
437240
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Baseline Pre intervention and Post-intervention approximately 1-2 weeks
after program completion
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Secondary outcome [2]
437625
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Wellbeing
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Assessment method [2]
437625
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The following validated, self-report measure will be administered at two time points at the intervention site and used to measure effectiveness of the program on wellbeing:
1. MHC-SF (Mental Health Continuum Short-Form)
2. SWLS (Satisfaction with Life Scale)
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Timepoint [2]
437625
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Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
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Secondary outcome [3]
437626
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Social Support
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Assessment method [3]
437626
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The following validated, self-report measure will be administered at two time points at the intervention site and used to measure effectiveness of the program on social support: MSPSS (Multidimensional scale of perceived social support)
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Timepoint [3]
437626
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Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
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Secondary outcome [4]
437627
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Self-Care
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Assessment method [4]
437627
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The following validated, self-report measure will be administered at two time points at the intervention site and used to measure effectiveness of the program on self-care: CD-RISC 10 (Connor-Davidson Resilience Scale)
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Timepoint [4]
437627
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Baseline Pre intervention and Post-intervention approximately 1-2 weeks after program completion
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Secondary outcome [5]
437628
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Determine the feasibility of undertaking a definitive trial
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Assessment method [5]
437628
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Measured using an audit of study records including time and resources, recruitment rates, completeness of data collection and contamination identification and risk measures. Focus groups will collect participants and staff perspectives such as barriers to implementation and potential sources or impacts of contamination.
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Timepoint [5]
437628
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Post-intervention 1-2 weeks after trial completion
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Eligibility
Key inclusion criteria
Caregivers/parents of children enrolled into a CaFHS parenting group at the control or intervention sites, during the study period.
Staff who work at the intervention site or were involved in implementation, during the trial period.
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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
None
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
As the primary aim and objective is feasibility, there will be no formal hypothesis testing or inferential statistics.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
23/07/2024
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Date of last participant enrolment
Anticipated
27/08/2024
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Actual
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Date of last data collection
Anticipated
30/09/2024
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Actual
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Sample size
Target
48
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Accrual to date
6
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
316886
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Other Collaborative groups
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Name [1]
316886
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Health Translation SA (HTSA) Medical Research Future Fund (MRFF) Catalyst Grant Scheme, led by HTSA, supported by the Women's & Children's Hospital Foundation
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Address [1]
316886
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Country [1]
316886
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
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Country
Australia
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Secondary sponsor category [1]
319134
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Government body
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Name [1]
319134
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Preventive Health SA
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Address [1]
319134
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Country [1]
319134
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Australia
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Secondary sponsor category [2]
319137
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Government body
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Name [2]
319137
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Women’s and Children’s Health Network
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Address [2]
319137
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Country [2]
319137
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315650
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Women's and Children's Health Network Human Research Ethics Committee
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Ethics committee address [1]
315650
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https://www.wchn.sa.gov.au/research/human-research
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Ethics committee country [1]
315650
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Australia
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Date submitted for ethics approval [1]
315650
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22/05/2024
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Approval date [1]
315650
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17/06/2024
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Ethics approval number [1]
315650
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2024/HRE00067
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Summary
Brief summary
This multi-method evaluation will evaluate the feasibility, acceptability, and effectiveness of a caregiver wellbeing program delivered by CaFHS in South Australia. The caregiver wellbeing program will deliver evidence-informed caregiver wellbeing psychoeducation into these routine services. Our evaluation aims to determine whether the caregiver wellbeing program is feasible and acceptable to deliver within these routine services and whether it is effective in improving the wellbeing of caregivers. To achieve our aims, we will conduct pre- and post- program surveys and focus groups with caregivers who participated in the program, and staff who were involved in implementing or delivering the program. To support and evaluate a future statewide roll out, this study will also evaluate the feasibility of conducting a definitive trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135370
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Dr Sarah Hunter
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Address
135370
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Flinders University Caring Futures Institute, College of Nursing and Health Sciences, Sturt Road, Bedford Park SA 5042 GPO Box 2100 Adelaide SA 5001
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Country
135370
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Australia
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Phone
135370
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+61 8 8201 3120
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Fax
135370
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Email
135370
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[email protected]
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Contact person for public queries
Name
135371
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Sarah Hunter
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Address
135371
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Flinders University Caring Futures Institute, College of Nursing and Health Sciences, Sturt Road, Bedford Park SA 5042 GPO Box 2100 Adelaide SA 5001
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Country
135371
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Australia
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Phone
135371
0
+61 8 8201 3120
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Fax
135371
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Email
135371
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[email protected]
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Contact person for scientific queries
Name
135372
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Sarah Hunter
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Address
135372
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Flinders University Caring Futures Institute, College of Nursing and Health Sciences, Sturt Road, Bedford Park SA 5042 GPO Box 2100 Adelaide SA 5001
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Country
135372
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Australia
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Phone
135372
0
+61 8 8201 3120
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Fax
135372
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Email
135372
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Permission for sharing of individual data was not obtained in ethics.
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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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