Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000415606
Ethics application status
Approved
Date submitted
9/04/2014
Date registered
16/04/2014
Date last updated
26/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Strong Carers, Strong Communities: Testing a capacity building approach to empower Aboriginal family carers to address their needs.
Scientific title
"Gotta be sit down and worked out together”- using participatory action research to test an empowerment intervention addressing the needs of unpaid family carers of Aboriginal older people
Secondary ID [1] 284403 0
Nil
Universal Trial Number (UTN)
U1111-1155-4514
Trial acronym
SCSC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
empowerment 291588 0
depression 291589 0
carer burden
 291590 0
Condition category
Condition code
Mental Health 291965 291965 0 0
Depression
Public Health 291967 291967 0 0
Health promotion/education
Public Health 292036 292036 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participatory Action Research (PAR)- community facilitation. Over a period of 9-12 months per community.
i) Share community history. This will include relaying
information from recent survey data on function,
prevalence of dementia, falls, continence issues, chronic
pain, depression, service utilisation and carer burden
to the recruited community, via
council members, local stakeholders and nominated
community champions. A formal discussion about the
PAR process will be undertaken, with permission sought
from the council. This will take place in a workshop
setting, and provide a means for the community members
to express their knowledge and history.
(ii) Create a common vision. At this workshop the health
care area/areas to develop into a program, and selection of
potential community health champions to employ will be
discussed. Example of topics that may be chosen by the
community may include ways to minimise depression, how to access services, how to minimise
carer stress etc. The community can express their wishes regarding the topics to address. Support of
project champions will be provided by researchers and project staff and will comprise regular face-to-face as well as telephone and email contact.
(iii) Identify evaluation stakeholders. Other decisions to be made at this early stage with the
community group include, the involvement of other partners (e.g. NGO, local groups, clinic staff,
HACC staff and others), nomination of a steering committee, location and time of meetings, the role
of a facilitator and establishing a conflict resolution process to manage any unresolved disagreements.
(iv) Identify indicators and targets objectives. This includes determination of outcomes and utilising resources available in the community, and the documentation of an action plan. For
example as part of a falls prevention model, a target outcome may be a medical review for all over
45 years. Alternatively it may be that a number of people in the community are supported to
undergo Aged Care III certificates or other training. The community may choose to take part in a
formal empowerment program.
(v) Identify strategies to reach targets. This will be determined by each community, facilitated by
health champions, and recorded in the action plan. One strategy for example may include an
awareness raising campaign, or a recall system through Health Workers in the clinic to address a
particular health issue. Available culturally appropriate programs may be utilised (e.g. Looking out
for dementia, Alzheimer‘s Australia NT)
(vi) Track indicators and collect data. Researchers and health champions will facilitate this
process, that may include employment of local people to assist with data collection (see Outcome
measures below).
(vii) Analyse data. The frequency of data analysis and feedback will be determined by the group,
aiming for a number of informal reviews every 2-3 months, with a formal review at 9 months. The
2-3 monthly reviews is to ensure adequate progression towards target objectives, with review of information collected. The reviews also comprise the reflection/evaluation stages of the PAR cycle. Researchers will be collaborating on a regular basis with local champions to trouble shoot any issues, and will call on the community committee as required.
(viii) Communicate results. The data will be presented back to the community for the iterative cycle to continue. Within this process will be a discussion of the sustainability of programs developed, and how this will be achieved long term.
Intervention code [1] 289142 0
Treatment: Other
Comparator / control treatment
Regular service provision with 6-8 education sessions for carers. Over a period of 6-8 months per community.
Education sessions include: being a carer, depression, carer burden, dementia, incontinence, pain, falls, mobility and physical activity.
Duration of each education session is 2 hours.
Regular service provision continues.
Control group
Active

Outcomes
Primary outcome [1] 291871 0
Change in empowerment score on the Growth and Empowerment Measure
Timepoint [1] 291871 0
Baseline, 4-6 months, 9-12 months after intervention has commenced.
Secondary outcome [1] 307704 0
Change in score on Carer burden scale (part of Kimberley Indigenous Cognitive Assessment)
Timepoint [1] 307704 0
Baseline and 9-12 months post commencement of intervention
Secondary outcome [2] 307705 0
Change in depression score on KICA Dep scale (depression subscale of Kimberley Indigenous Cognitive Assessment)
Timepoint [2] 307705 0
Baseline and 9-12 months
Secondary outcome [3] 307706 0
Service utilisation change based on health service records
Timepoint [3] 307706 0
Baseline and 9-12 months

Eligibility
Key inclusion criteria
Unpaid Aboriginal Australian carers of people living with disabilities, mental illness and frail aged living in remote Aboriginal communities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years
Live outside randomised communities
Acutely unwell
Non Aboriginal
Non carer

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. The Aboriginal communities (clusters) will be randomised into intervention or control group prior to recruitment of individual participants. The project staff recruiting individual participants are aware which group the community has been randomised into.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on data of the Growth and Empowerment Measure (GEM, Haswell et al 2010) applied to a similar adult population, and assuming a correlation of 0.6 between baseline and follow-up testing of an individual; we expect that a study of 304 subjects (152 in each group) would have 80% power to detect an effect of 3 points on 12 S (GEM) and 4 points on ESS-14 (GEM) assuming an intraclass correlation of 0.01 for the communities and p < 0.05 (2 tailed).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/05/2014
Actual
5/05/2014
Date of last participant enrolment
Anticipated
4/04/2016
Actual
30/11/2017
Date of last data collection
Anticipated
Actual
30/11/2017
Sample size
Target
304
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7974 0
6725 - Dampier Peninsula
Recruitment postcode(s) [2] 7975 0
6728 - Camballin
Recruitment postcode(s) [3] 7976 0
6728 - Derby
Recruitment postcode(s) [4] 7977 0
6765 - Fitzroy Crossing
Recruitment postcode(s) [5] 7978 0
6770 - Tanami
Recruitment postcode(s) [6] 7979 0
6743 - Warmun

Funding & Sponsors
Funding source category [1] 289056 0
Government body
Name [1] 289056 0
National Health and Medical Research Council
Country [1] 289056 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia
35 Stirling Highway
Crawley, Perth
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 287724 0
None
Name [1] 287724 0
Address [1] 287724 0
Country [1] 287724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290853 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 290853 0
Ethics committee country [1] 290853 0
Australia
Date submitted for ethics approval [1] 290853 0
Approval date [1] 290853 0
22/02/2013
Ethics approval number [1] 290853 0
RA/4/1/5894
Ethics committee name [2] 290854 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 290854 0
Ethics committee country [2] 290854 0
Australia
Date submitted for ethics approval [2] 290854 0
Approval date [2] 290854 0
15/02/2013
Ethics approval number [2] 290854 0
454
Ethics committee name [3] 290855 0
Western Australia Country Health Service Human Research Ethics Committee
Ethics committee address [3] 290855 0
Ethics committee country [3] 290855 0
Australia
Date submitted for ethics approval [3] 290855 0
24/03/2014
Approval date [3] 290855 0
Ethics approval number [3] 290855 0

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

Contacts
Principal investigator
Name 47278 0
Dr Dina LoGiudice
Address 47278 0
Clinical Associate Professor,
Physician Aged Care
Royal Park, Melbourne Health
34 Poplar Rd Parkville, VIC 3052
Country 47278 0
Australia
Phone 47278 0
61 3 8387 2000
Fax 47278 0
Email 47278 0
[email protected]
Contact person for public queries
Name 47279 0
Christianne White
Address 47279 0
WA Centre for Health and Ageing (M577)
University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country 47279 0
Australia
Phone 47279 0
+61 8 9224 4515
Fax 47279 0
Email 47279 0
[email protected]
Contact person for scientific queries
Name 47280 0
Kate Smith
Address 47280 0
WA Centre for Health and Ageing (M577)
University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country 47280 0
Australia
Phone 47280 0
+61 8 9224 4518
Fax 47280 0
Email 47280 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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