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Trial registered on ANZCTR
Registration number
ACTRN12619000656134
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
1/05/2019
Date last updated
17/01/2023
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Dementia prevention and risk Management Program for Aboriginal Australians - DAMPAA Project
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Scientific title
The DAMPAA Project: a randomised controlled trial of the effects of a 6 month exercise, education and cardiovascular risk management program or Usual Care and education program on cognition, quality of life and cardiovascular risk in Aboriginal Australians aged between 45 and 90 years
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Secondary ID [1]
295857
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
DAMPAA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
dementia
309318
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cognitive impairment not dementia
309319
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cardiovascular risk factors
309320
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functional impairment
309321
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falls
309954
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Condition category
Condition code
Neurological
308184
308184
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0
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Dementias
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Cardiovascular
308729
308729
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0
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Other cardiovascular diseases
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Injuries and Accidents
308761
308761
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
For the DAMPAA group (name of intervention group) a group centre-based balance, strengthening and moderate level exercise program will be delivered twice a week for 6 months following intervention protocol, with home/community based exercise to be completed 1 day a week. Group sessions (10 -15 participants) will be delivered primarily at the 3 Aboriginal Community Controlled Health Services sites by exercise physiologists or physiotherapists and Aboriginal health workers (Aboriginal care coordinators), with home programs tailored to participants’ needs. The target exercise program will consist of 3 x 50 minutes of moderate level exercise per week (such as brisk walking) and standing balance and strengthening items. Exercise intensity will be monitored with heart rate monitors during the sessions. Home-based exercise compliance will be monitored by asking participants to self-rate on a visual scale. Both exercise programs will be progressive in terms of duration of the sessions and the intensity of the exercise over the first 8 weeks until the target exercise is reached. The home-based program will be a continuation of the program devised by the exercise physiologist/physiotherapist for the centre-based program. The weekly home-based session will be a repeat of the centre-based session with the balance and strengthening exercises prescribed by the exercise physiologist/physiotherapist based on the individual's exercise capacity, mobility and fitness needs. The main exercise component of aerobic or circuit work will also be selected based on the individual's exercise needs and for the home-based program availability of space and community programs. Progress on both centre and home-based programs will be monitored (as above) and by written and verbal reports from the participants at the centre-based sessions and the text replies for the home-based sessions. The individual’s programs will revised weekly by the exercise physiologist/physiotherapist with any necessary adjustments made to the individual's program re exercises, duration and intensity.
General educational materials relating to the risk factors for dementia will be developed in house and presented in printed form to both DAMPAA and control groups at the start of the study. For the DAMPAA intervention group additional education will be delivered face-to-face by the Aboriginal Health Worker/exercise specialist/health professional in a series of 1-hour workshops over a 6-month period with sessions conducted at 3-4 weekly intervals. Individually tailored incidental education will also be provided by the Aboriginal Health Worker and/or the exercise specialist over the 6 month action stage (e.g. falls risk, smoking cessation, medication adherence).
Motivational care planning and goal setting will be used to tailor the program to DAMPAA group participants, and to maximise adherence to the intervention. Adherence to the exercise program will be monitored by the exercise physiologist and Aboriginal Health worker for both centre-based sessions (via attendance records) and home based sessions (via phone or query at subsequent centre-based session). Reviews of blood pressure, blood glucose levels, and medications will occur at centre-based sessions for the DAMPAA program participants in between the key data collection stages. Referrals will be made as required, and discussed with the GP.
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Intervention code [1]
312502
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Lifestyle
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Intervention code [2]
312503
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Prevention
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Intervention code [3]
312611
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Behaviour
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Comparator / control treatment
At their initial interview the Usual care group will receive educational materials on the risk factors for dementia in Aboriginal people only. These materials encompass the life course approach to brain health and for ethical reasons will be provided to both Usual care and DAMPAA groups and their families. After their 12 month data collection, the control group will be offered the next available DAMPAA program or an existing site program.
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Control group
Active
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Outcomes
Primary outcome [1]
307552
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Cognitive decline measured by the KICA-Cog assessment (Kimberley Indigenous Cognitive Assessment)
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Assessment method [1]
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Timepoint [1]
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Baseline, 6 and 12 months.
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Primary outcome [2]
307553
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Daily function measured by the KICA-ADL (Kimberley Indigenous Cognitive Assessment Activities of Daily Life questionnaire), or death recorded through hospital linkage data and through follow up with next of kin.
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Assessment method [2]
307553
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Timepoint [2]
307553
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Baseline, 6 and 12 months.
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Primary outcome [3]
307564
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Quality of life; measured using the Good Spirit Good Life questionnaire and EQ5D5L tool
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Assessment method [3]
307564
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Timepoint [3]
307564
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Baseline 6 and 12 months.
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Secondary outcome [1]
352300
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Change in blood pressure - using an automatic blood pressure monitor
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Assessment method [1]
352300
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Timepoint [1]
352300
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Baseline 6 and 12 months.
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Secondary outcome [2]
352301
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Number of falls in last 6 months, measured through questionnaire (Falls Risk in Older People - Community (FROP-Com) screening tool)
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Assessment method [2]
352301
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Timepoint [2]
352301
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Baseline, 6 and 12 months.
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Secondary outcome [3]
352750
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Health Economic Costing through health data linkage and documentation of resources used throughout the study
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Assessment method [3]
352750
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Timepoint [3]
352750
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12 months after randomisation.
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Secondary outcome [4]
368951
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Change in blood lipids (cholesterol, triglycerides) reflecting cardiovascular risk - via fasted blood test
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Assessment method [4]
368951
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Timepoint [4]
368951
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Baseline, 6 and 12 months.
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Secondary outcome [5]
368952
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Blood glucose control measured as glycated haemoglobin (HbA1c) from fasted blood test
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Assessment method [5]
368952
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Timepoint [5]
368952
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Baseline, 6 and 12 months.
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Secondary outcome [6]
368954
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Body weight and body composition using bioimpedance scales
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Assessment method [6]
368954
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Timepoint [6]
368954
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baseline 6 and 12 months.
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Secondary outcome [7]
368955
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Waist and hip girths measured with constant tension tape
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Assessment method [7]
368955
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Timepoint [7]
368955
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Baseline, 6 and 12 months.
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Secondary outcome [8]
368956
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Smoking status and alcohol intake from KICA smoking and alcohol questionnaires
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Assessment method [8]
368956
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Timepoint [8]
368956
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Baseline, 6 and 12 months.
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Secondary outcome [9]
368957
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Functional capacity through step test for balance (Hill, 1996);
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Assessment method [9]
368957
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Timepoint [9]
368957
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Baseline; 6 months, 12 months after intervention commencement
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Secondary outcome [10]
368958
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Regular physical activity levels through RAPA questionnaire (Rapid Assessment of Physical Activity)
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Assessment method [10]
368958
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Timepoint [10]
368958
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Baseline; 6 months, 12 months after intervention commencement
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Secondary outcome [11]
368959
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Cognitive performance measured via Hopkins Verbal Learning Test,
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Assessment method [11]
368959
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Timepoint [11]
368959
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Baseline; 6 months, 12 months after intervention commencement
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Secondary outcome [12]
368960
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Cognitive performance measured by Colour Trails test,
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Assessment method [12]
368960
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Timepoint [12]
368960
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Baseline; 6 months, 12 months after intervention commencement
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Secondary outcome [13]
368961
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Cognitive performance measured by Symbol Digit Modalities test,
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Assessment method [13]
368961
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Timepoint [13]
368961
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Baseline; 6 months, 12 months after intervention commencement
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Secondary outcome [14]
368962
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Anxiety and depression status via GAD7 and KICA questionnaires.
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Assessment method [14]
368962
0
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Timepoint [14]
368962
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Baseline; 6 months, 12 months after intervention commencement
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Secondary outcome [15]
401058
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Program Evaluation Questionnaire to assess the content and processes of the study and the acceptability of the program.
With their consent this questionnaire will also be delivered to any participants withdrawing from the study. This is a study specific Questionnaire.
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Assessment method [15]
401058
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Timepoint [15]
401058
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6, and 12 months.
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Secondary outcome [16]
401059
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2-minute walk test of cardiovascular fitness. Included prior to enrolment.
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Assessment method [16]
401059
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Timepoint [16]
401059
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Baseline, 6 and 12 months
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Secondary outcome [17]
401060
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Sit to Stand Test - Timed 5 sit stands. Added prior to enrolment in the main study.
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Assessment method [17]
401060
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Timepoint [17]
401060
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baseline, 6 and 12 months
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Secondary outcome [18]
401061
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Timed Up And Go test of mobility.
Added prior to enrolment in the main study.
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Assessment method [18]
401061
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Timepoint [18]
401061
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baseline, 6 and 12 months.
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Secondary outcome [19]
401062
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Hand Grip strength measured with dynamometer.
Added before enrolment in the main study.
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Assessment method [19]
401062
0
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Timepoint [19]
401062
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Baseline, 6 and 12 months.
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Secondary outcome [20]
401063
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The Montreal Cognitive Assessment (MoCA)
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Assessment method [20]
401063
0
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Timepoint [20]
401063
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Baseline, 6 and 12 months
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Eligibility
Key inclusion criteria
1) Aboriginal Australian and/or Torres Strait Islander 2) aged between 45 and 90 years; 3) community dwelling; 4) cognitive impairment with no dementia (defined by score of 31-37 out of 39 on KICA Cog and no functional decline due to cognitive impairment) and no cognitive impairment (38-39 out of 39 on KICA Cog);
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Minimum age
45
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) dementia 2) presence of medical condition that restricts walking without assistance; 3) unstable or life threatening medical condition; 4) medical condition that contra-indicates moderate physical activity.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Participants will be allocated based on computer randomisation off site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
STATA and the user-written program Ralloc will be used for computer generated randomisation at the individual level.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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
All quantitative data will be entered and analysed using Stata 14. We will use a generalised linear mixed model to compare changes in the KICA-Cog (cognition, primary outcome measure) over time between the two groups. The covariates in this model will be the baseline KICA-Cog score, time (6, 12, months, entered as a categorical variable), group (intervention or control) and an interaction between group and time. Participants will be treated as a random effect. Similar models will be run for the secondary outcomes which are a mixture of variable types (proportions, counts, etc.) So, for example, mixed-effects logistic regression will be used in the analysis of the proportion of participants who die or experience declining function (on the KICA ADL) and mixed-effects. Poisson regression will be used for the analysis of the number of falls.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/06/2019
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Actual
14/10/2020
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Date of last participant enrolment
Anticipated
28/02/2023
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Actual
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Date of last data collection
Anticipated
31/03/2024
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Actual
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Sample size
Target
70
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Accrual to date
30
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment postcode(s) [1]
24161
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6004 - East Perth
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Recruitment postcode(s) [2]
24289
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6056 - Midland
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Recruitment postcode(s) [3]
39302
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6147 - Langford
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Recruitment postcode(s) [4]
24159
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6530 - Geraldton
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Funding & Sponsors
Funding source category [1]
300456
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Government body
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Name [1]
300456
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National Health and Medical Research Council
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Address [1]
300456
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GPO Box 1421 Canberra ACT 2601
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Country [1]
300456
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Australia
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Primary sponsor type
University
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Name
The University of Western Australia
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Address
35 Stirling Hwy, Crawley Western Australia 6009
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Country
Australia
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Secondary sponsor category [1]
300307
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None
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Name [1]
300307
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Address [1]
300307
0
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Country [1]
300307
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301259
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Western Australian Aboriginal Health Ethics Committee
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Ethics committee address [1]
301259
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450 Beaufort Street, Highgate, Perth Western Australia 6003
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Ethics committee country [1]
301259
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Australia
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Date submitted for ethics approval [1]
301259
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20/08/2018
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Approval date [1]
301259
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25/09/2018
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Ethics approval number [1]
301259
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867
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Ethics committee name [2]
309474
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University of Western Australia Human Research Ethics Committee
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Ethics committee address [2]
309474
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M459 35 Stirling Hwy, Crawley, WA 6009
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Ethics committee country [2]
309474
0
Australia
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Date submitted for ethics approval [2]
309474
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22/10/2018
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Approval date [2]
309474
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07/11/2018
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Ethics approval number [2]
309474
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RA/4/20/4944
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Summary
Brief summary
This study aims to produce an Aboriginal Health Practitioner coordinated risk factor management program to reduce cognitive decline and functional impairment in Aboriginal Australians aged 45 years and over. The Dementia prevention and risk management program for Aboriginal Australians (DAMPAA) program will include AHP coordination and care planning of a) an exercise program including falls prevention strategies; b) cardiovascular risk management. This will be achieved through a 5 year research project in partnership with three ACCHS’s by: 1) Refining and piloting an intervention program (DAMPAA) that targets key dementia risk factors for Aboriginal people, and is based on existing best practice guidelines and cultural and service provider recommendations. 2) Completing a randomized controlled trial (RCT) comparing the DAMPAA program with usual care; 3) Evaluating the efficacy and cost-effectiveness of the DAMPAA. Significance: Given the rapid ageing of the Aboriginal population, the impact that dementia has on Aboriginal communities, and the resulting financial cost to society, there is a pressing need to develop and translate programs capable of reducing dementia in Aboriginal Australians. This project will produce a prevention program designed to meet the needs of Aboriginal Australians at risk of dementia.
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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
86394
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Dr Kate Smith
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Address
86394
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M577, University of Western Australia, 35 Stirling Hwy Crawley Western Australia 6009
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Country
86394
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Australia
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Phone
86394
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+61 08 9224 4518
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Fax
86394
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Email
86394
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kate.smith@uwa.edu.au
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Contact person for public queries
Name
86395
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Alex Lalovic
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Address
86395
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M577, University of Western Australia, 35 Stirling Hwy Crawley Western Australia 6009
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Country
86395
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Australia
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Phone
86395
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+61 08 9224 4515
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Fax
86395
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Email
86395
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wacha@uwa.edu.au
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Contact person for scientific queries
Name
86396
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Kate Smith
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Address
86396
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M577, University of Western Australia, 35 Stirling Hwy Crawley Western Australia 6009
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Country
86396
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Australia
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Phone
86396
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+61 08 9224 4518
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Fax
86396
0
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Email
86396
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kate.smith@uwa.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified participant data underlying published results only, by secure transfer, that has been approved for data sharing by the WA Aboriginal Health Ethics Committee, and the Chief investigator group.
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When will data be available (start and end dates)?
From publication to 10 years post publication.
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Available to whom?
Researchers who provide a methodologically and culturally sound proposal will be evaluated on a case by case basis with the Chief Investigators and the WA Aboriginal Health Ethics Committee.
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Available for what types of analyses?
Only to achieve the aims in the approved proposal.
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How or where can data be obtained?
Subject to proposal approvals and signing of data access agreement, via secure transfer.
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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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