Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001485224
Ethics application status
Approved
Date submitted
29/08/2018
Date registered
4/09/2018
Date last updated
30/05/2023
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Let's CHAT (Community Health Approaches To) Dementia in Aboriginal and Torres Strait Islander Communities.
Scientific title
Let's CHAT (Community Health Approaches To) Dementia in Aboriginal and Torres Strait Islander Communities
Secondary ID [1] 295058 0
None
Universal Trial Number (UTN)
U1111-1215-2403
Trial acronym
Let's CHAT Dementia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 308108 0
Cognitive Impairment Not Dementia 308791 0
Condition category
Condition code
Neurological 307147 307147 0 0
Dementias
Neurological 308303 308303 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a stepped wedge cluster randomised control trial of 12 clusters in 4 states. Each cluster will experience the intervention with four clusters commencing participation at each of three time points - within 6 months, within 12 months and within 18 months of commencement of data collection (NOTE: the timeline of the study has been disrupted due to the pandemic. The services will still enter the intervention phase at three time points, however there is now a hiatus period corresponding to societal lockdown, between when the second and third cluster enter the intervention phase). The main intervention includes training and support to staff within Aboriginal Community Controlled Health Services (ACCHS) that offer primary care with the aim of strengthening capacity to diagnose and manage older Aboriginal and Torres Strait Islander People with dementia. The training and support will include:
• a Best Practice Guide for cognitive impairment and dementia care in the primary care setting,
• Decision Support Tools, including: cognitive screenings and assessments that can be incorporated into the Aboriginal and Torres Strait Islander 715 assessment, or designed as stand-alone tools; culturally tailored cognitive impairment/dementia care pathways.
• A package of resources developed in collaboration with each health service specifically for this study, and tailored for use in each health service. It will include both online/web-enabled and face-to-face options.
• Professional Development/Training and organisational development as part of a Continuous Quality Improvement (CQI) process. Once each health service enters the implementation phase, regular training and support will be provided by experienced health professionals and educators with specific knowledge about Best Practice Dementia care. The training will be conducted face-to-face in the health services, or via videoconference if this is not possible due to pandemic restrictions. Training and support from the available package of resources will be tailored where possible to the identified needs of each agency and scheduled as requested by each health service. In accordance with the stepped-wedge design (see attachment), health services will enter the training and support phase of the study in a staggered, six-monthly interval sequence. By mid-2021 all health services will be receiving the implementation. The training and support phase will end in Early 2023.
Intervention code [1] 301393 0
Other interventions
Comparator / control treatment
The comparator will be usual care provided by the participating ACCHSs before they commence with the study intervention (training and support for CQI, professional development, Best Practice Guide and Decision Support Tools). Each health service (site/cluster) will be randomised at the beginning of the project to determine the sequence of commencement of training. Sites will enter the study at 6 month cycles, and each of the 12 sites will provide a minimum of 55 active clients aged 50 years and over for whom file audits will be conducted in order to determine client outcomes.
Control group
Active

Outcomes
Primary outcome [1] 306103 0
Documentation of cognitive screening and assessment, and management of dementia and CIND in client files of Indigenous people aged 50 and over attending Aboriginal Primary Care Services as assessed by audit of ACCHS records.
Timepoint [1] 306103 0
At each six-monthly audit phase from baseline (September/October 2018) until April 2023 (see data collection timeline attachment).
Secondary outcome [1] 347596 0
Patient cognitive decline as assessed by the Kimberley Indigenous Cognitive Assessment (KICA) and the Clock Drawing test.. Vision and hearing are measured to determine the impact on cognitive assessment outcomes for the individual participant.
Timepoint [1] 347596 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [2] 351327 0
Patient co-morbidity as assessed by the Charlson Co-morbidity Index
Timepoint [2] 351327 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [3] 351328 0
Patient Nutrition as assessed by Mini Nutritional Assessment
Timepoint [3] 351328 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [4] 351329 0
Patient Falls risk as assessed by Elderly Falls Screening Test
Timepoint [4] 351329 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [5] 351330 0
Patient Frailty as assessed by a composite of the Fried Frailty Index and hand grip strength, walking speed and gait, muscle mass and body mass index.
Timepoint [5] 351330 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [6] 351331 0
Patient Pain as assessed by Pain Scale adapted from Brief Pain Inventory
Timepoint [6] 351331 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [7] 351332 0
Patient Continence as assessed by Modified ICIQ Continence Questionnaire
Timepoint [7] 351332 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [8] 351333 0
Patient depression as assessed by Modified PHQ-9 Depression Scale
Timepoint [8] 351333 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [9] 351334 0
Depression as assessed by the KICA-Dep tool.
Timepoint [9] 351334 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [10] 351335 0
Patient Health Related Quality of Life (HRQOL) as assessed by EQ-5D tool and the Good Spirit Good Life tool
Timepoint [10] 351335 0
At two timepoints (six monthly) from when the participant's health service enters the implementation phase (see data collection timeline attachment). Note that while individual participants will participate in assessments annually, patients eligible for assessment will be identified and invited to participate at each six-monthly audit cycle.
Secondary outcome [11] 351336 0
Carer Strain as assessed by Adapted Zarit-6 Assessment
Timepoint [11] 351336 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [12] 351337 0
Carer Depression as assessed by KICA-Dep
Timepoint [12] 351337 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [13] 351338 0
Carer Health Related Quality of Life (HRQOL) as assessed by EQ-5D tool
Timepoint [13] 351338 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [14] 351339 0
Medication use as documented in Pharmaceutical Benefits Scheme (PBS) data.
Timepoint [14] 351339 0
Victorian services: 30/9/2018 - 30/9/2023
WA services: 31/8/2018 - 30/6/2023
Qld services: 30/1/2019 - 30/6/2023
NSW services: 30/9/2018 - 30/6/2023
Secondary outcome [15] 351357 0
Health service use as documented in Medicare/MBS data.
Timepoint [15] 351357 0
February 2020
Secondary outcome [16] 351358 0
Hospital use as documented in hospital use data.
Timepoint [16] 351358 0
Victorian services: 30/9/2018 - 30/9/2023
WA services: 31/8/2018 - 30/6/2023
Qld services: 30/1/2019 - 30/6/2023
NSW services: 30/9/2018 - 30/6/2023
Secondary outcome [17] 403472 0
Patient function as assessed by the function section of the KICA tool
Timepoint [17] 403472 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [18] 403473 0
Alcohol use as assessed by the AUDIT C Tool
Timepoint [18] 403473 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [19] 403474 0
Physical activity as assessed by Rapid Assessment of Physical Activity (RAPA)
Timepoint [19] 403474 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [20] 403475 0
Measures of psychosocial stress as assessed by the Negative Life Events Scale and the addition of questions about the Stolen Generation.
Timepoint [20] 403475 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.
Secondary outcome [21] 403476 0
Medications taken by patients invited to participate in the full comprehensive geriatric assessment and shorter follow-up assessments at 6-month intervals.
Timepoint [21] 403476 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment. Medications taken at the time of the full assessment will be reported and not at subsequent 6-monthly follow ups.
Secondary outcome [22] 403477 0
Medication prescriptions and prevalence of polypharmacy from single cross-sectional audit of patient health records at three strategically selected Aboriginal Primary Care Services in urban, regional and remote areas.
Timepoint [22] 403477 0
Medications prescribed within the 6-month baseline auditing period were recorded from patient records' for previously audited Indigenous patients aged 50 years and over at three strategically selected ACCHS in urban, rural and remote areas.
Secondary outcome [23] 403478 0
Exhaustion as measured by the exhaustion tool from the CES-D Depression Scale
Timepoint [23] 403478 0
Patients eligible for assessment (plus two controls for each) will be identified and invited to participate at each six-monthly audit cycle. Each patient will complete one full assessment.

Eligibility
Key inclusion criteria
1. Primary Health Care Services (Aboriginal Community Controlled Health Organisations) that:
(i) Utilise a health care software system such as MMEX or Communicare;
(ii) Utilise MBS item 715 (health check)
(iii) have GPs and Indigenous health workers, and/or practice nurses who assist delivery of health checks;
(iv) participate in CQI
2. Indigenous people aged 50 years or over attending one of the participating ACCHSs who are eligible to complete a 715 MBS health check +/- available carer/family member.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i)People severely unwell with high likelihood of death within 6 months;
(ii) not resident in the area for the last 12 months;
(iii) residing in residential care;
(iv) not active clients of the service according to RACGP criteria.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - random allocation of clusters will be completed independently by the project statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participating agencies in each of the four study states (3 agencies per state) will be randomly allocated to timing of intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study is a stepped wedge cluster design involving 12 clusters randomly assigned in groups of four to one of three steps.
Health service clients identified during the audit phases as having cognitive impairment or dementia will be invited to participate in a comprehensive assessment plus follow up quality of life assessment at 6 months and 12 months.. As part of a nested case-control study, for each participant, two age and gender matched controls will also be invited to participate in the comprehensive assessments.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be conducted using generalised linear mixed methods (GLMM) where variation between clusters will be modelled as a random intercept effect and, nested within these time will be treated as a random coefficient effect. No single model can assess all the possible time related effects that may be of interest and to this end up to four different model configurations will be used to outlined in Twisk JW et al (2016). Reference: Twisk JW, Hoogendijk EO, Zwijsen SA et al. Different methods to analyse stepped wedge trial designs revealed different aspects of intervention effects. 2016. J Clin Epidemiol 72: 75-83.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
1/06/2019
Date of last participant enrolment
Anticipated
15/06/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
180
Accrual to date
76
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 299639 0
Government body
Name [1] 299639 0
National Health and Medical Research Council (NHMRC)
Country [1] 299639 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
c/- Building 21
Royal Park Campus
Melbourne Health
Park St
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 298964 0
University
Name [1] 298964 0
University of Western Australia
Address [1] 298964 0
University of Western Australia
WA Centre for Health Ageing
MRF Building,
Level 6 Rear 50 Murray St,
Perth WA, 6000
Country [1] 298964 0
Australia
Secondary sponsor category [2] 299019 0
University
Name [2] 299019 0
Neuroscience Research Australia (NeuRA)
Address [2] 299019 0
Margarete Ainsworth Building
Barker Street
Randwick, 2013, NSW
Australia
Country [2] 299019 0
Australia
Secondary sponsor category [3] 299505 0
University
Name [3] 299505 0
James Cook University
Address [3] 299505 0
c/- College of Medicine & Dentistry,
James Cook University
Cairns Clinical School
2nd Floor A Block
Cairns Base Hospital,
Cairns Qld 4870
Country [3] 299505 0
Australia
Secondary sponsor category [4] 299506 0
University
Name [4] 299506 0
University of South Australia
Address [4] 299506 0
c/-Institute for Choice
UniSA Business School
Way Lee Building, Room WL3-65
City West Campus
North Terrace
Adelaide, South Australia 5000
Country [4] 299506 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300583 0
Aboriginal Health and Medical Research Council Ethics Committee
Ethics committee address [1] 300583 0
Ethics committee country [1] 300583 0
Australia
Date submitted for ethics approval [1] 300583 0
17/01/2018
Approval date [1] 300583 0
26/03/2018
Ethics approval number [1] 300583 0
1362/18
Ethics committee name [2] 301336 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [2] 301336 0
Ethics committee country [2] 301336 0
Australia
Date submitted for ethics approval [2] 301336 0
14/06/2018
Approval date [2] 301336 0
27/07/2018
Ethics approval number [2] 301336 0
1851943
Ethics committee name [3] 301337 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [3] 301337 0
Ethics committee country [3] 301337 0
Australia
Date submitted for ethics approval [3] 301337 0
15/06/2018
Approval date [3] 301337 0
25/07/2018
Ethics approval number [3] 301337 0
858
Ethics committee name [4] 313111 0
Aboriginal Health and Medical Research Committee
Ethics committee address [4] 313111 0
Ethics committee country [4] 313111 0
Australia
Date submitted for ethics approval [4] 313111 0
17/08/2021
Approval date [4] 313111 0
07/03/2022
Ethics approval number [4] 313111 0
1855/21

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

Contacts
Principal investigator
Name 83986 0
A/Prof Dina LoGiudice
Address 83986 0
The University of Melbourne
c/-Building 21, Royal Park Campus
Melbourne Health
Park Street
Parkville 3052 VIC
Country 83986 0
Australia
Phone 83986 0
+ 61 383872000
Fax 83986 0
Email 83986 0
Dina.Logiudice@mh.org.au
Contact person for public queries
Name 83987 0
Jo-anne Hughson
Address 83987 0
The University of Melbourne c/- Building 21, Royal Park Campus - Royal Melbourne Hospital 34-54 Poplar Road, Parkville 3052 VIC
Country 83987 0
Australia
Phone 83987 0
+61 425710396
Fax 83987 0
Email 83987 0
hughson@unimelb.edu.au
Contact person for scientific queries
Name 83988 0
Dina LoGiudice
Address 83988 0
The University of Melbourne c/- Building 21, Royal Park Campus - Royal Melbourne Hospital 34-54 Poplar Road, Parkville 3052 VIC
Country 83988 0
Australia
Phone 83988 0
+61 383872000
Fax 83988 0
Email 83988 0
Dina.Logiudice@mh.org.au

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


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14225Other    Project timeline 375232-(Uploaded-21-10-2021-13-43-07)-Study-related document.docx
14226Study protocolBradley K, Smith R, Hughson JA, Atkinson D, Bessarab D, Flicker L, Radford K, Smith K, Strivens E, Thompson S, Blackberry I. Let’s CHAT (community health approaches to) dementia in Aboriginal and Torres Strait Islander communities: protocol for a stepped wedge cluster randomised controlled trial. BMC Health Services Research. 2020 Dec;20(1):1-3.https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-020-4985-1hughson@unimelb.edu.au 375232-(Uploaded-29-03-2021-17-04-53)-Study-related document.pdf
19293Other    Updates made to project timeline due to COVID disr... [More Details] 375232-(Uploaded-24-05-2023-11-25-06)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14225Other    Project timeline 375232-(Uploaded-21-10-2021-13-43-07)-Study-related document.docx
14226Study protocolBradley K, Smith R, Hughson JA, Atkinson D, Bessarab D, Flicker L, Radford K, Smith K, Strivens E, Thompson S, Blackberry I. Let’s CHAT (community health approaches to) dementia in Aboriginal and Torres Strait Islander communities: protocol for a stepped wedge cluster randomised controlled trial. BMC Health Services Research. 2020 Dec;20(1):1-3.https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-020-4985-1hughson@unimelb.edu.au 375232-(Uploaded-29-03-2021-17-04-53)-Study-related document.pdf
19293Other    Updates made to project timeline due to COVID disr... [More Details] 375232-(Uploaded-30-05-2024-12-49-39)-LCD timeline with follow up audits.pdf

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.