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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
1/05/2019
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
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
Secondary ID [1] 295857 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DAMPAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia
309318 0
cognitive impairment not dementia 309319 0
cardiovascular risk factors 309320 0
functional impairment 309321 0
falls 309954 0
Condition category
Condition code
Neurological 308184 308184 0 0
Dementias
Cardiovascular 308729 308729 0 0
Other cardiovascular diseases
Injuries and Accidents 308761 308761 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312502 0
Lifestyle
Intervention code [2] 312503 0
Prevention
Intervention code [3] 312611 0
Behaviour
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 18 month data collection, the control group will be offered the next available DAMPAA program or an existing site program.
Control group
Active

Outcomes
Primary outcome [1] 307552 0
Cognitive decline measured by the KICA-Cog assessment (Kimberley Indigenous Cognitive Assessment)
Timepoint [1] 307552 0
Baseline; 6 months, 12 months and 18 months (primary timepoint) after intervention commencement
Primary outcome [2] 307553 0
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.
Timepoint [2] 307553 0
Baseline; 6 months, 12 months and 18 months (primary timepoint) after intervention commencement
Primary outcome [3] 307564 0
Quality of life; measured using the Good Spirit Good Life questionnaire and EQ5D5L tool.
Timepoint [3] 307564 0
Baseline; 6 months, 12 months and 18 months (primary timepoint) after intervention commencement
Secondary outcome [1] 352300 0
Change in blood pressure - using an automatic blood pressure monitor
Timepoint [1] 352300 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [2] 352301 0
Number of falls in last 6 months, measured through questionnaire (Falls Risk in Older People - Community (FROP-Com) screening tool)
Timepoint [2] 352301 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [3] 352750 0
Health Economic Costing through health data linkage and documentation of resources used throughout the study
Timepoint [3] 352750 0
18 months after randomisation
Secondary outcome [4] 368951 0
Change in blood lipids (cholesterol, triglycerides) reflecting cardiovascular risk - via fasted blood test
Timepoint [4] 368951 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [5] 368952 0
Blood glucose control measured as glycated haemoglobin (HbA1c) from fasted blood test
Timepoint [5] 368952 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [6] 368953 0
Kidney function measured as eGFR and albumin from fasted blood test
Timepoint [6] 368953 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [7] 368954 0
Body weight and body composition using bioimpedance scales
Timepoint [7] 368954 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [8] 368955 0
Waist and hip girths measured with constant tension tape
Timepoint [8] 368955 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [9] 368956 0
Smoking status and alcohol intake from KICA smoking and alcohol questionnaires
Timepoint [9] 368956 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [10] 368957 0
Functional capacity through step test for balance (Hill, 1996); 2 minute walk, sit-to-stand and Timed Up and Go test scores
Timepoint [10] 368957 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [11] 368958 0
Regular physical activity levels through RAPA questionnaire (Rapid Assessment of Physical Activity)
Timepoint [11] 368958 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [12] 368959 0
Cognitive performance measured via Hopkins Verbal Learning Test,
Timepoint [12] 368959 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [13] 368960 0
Cognitive performance measured by Colour Trails test,
Timepoint [13] 368960 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [14] 368961 0
Cognitive performance measured by Symbol Digit Modalities test,
Timepoint [14] 368961 0
Baseline; 6 months, 12 months and 18 months after intervention commencement
Secondary outcome [15] 368962 0
Anxiety and depression status via GAD7 and KICA questionnaires.
Timepoint [15] 368962 0
Baseline; 6 months, 12 months and 18 months after intervention commencement

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 32-36 out of 39 on KICA Cog, and no functional decline due to cognitive impairment).
Minimum age
45 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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, or 18 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 24159 0
6530 - Geraldton
Recruitment postcode(s) [2] 24161 0
6004 - East Perth
Recruitment postcode(s) [3] 24289 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 300456 0
Government body
Name [1] 300456 0
National Health and Medical Research Council
Address [1] 300456 0
GPO Box 1421 Canberra ACT 2601
Country [1] 300456 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Hwy, Crawley Western Australia 6009
Country
Australia
Secondary sponsor category [1] 300307 0
None
Name [1] 300307 0
Address [1] 300307 0
Country [1] 300307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301259 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 301259 0
450 Beaufort Street, Highgate, Perth Western Australia 6003
Ethics committee country [1] 301259 0
Australia
Date submitted for ethics approval [1] 301259 0
20/08/2018
Approval date [1] 301259 0
25/09/2018
Ethics approval number [1] 301259 0
867

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86394 0
Dr Kate Smith
Address 86394 0
M577, University of Western Australia, 35 Stirling Hwy Crawley Western Australia 6009
Country 86394 0
Australia
Phone 86394 0
+61 08 9224 4518
Fax 86394 0
Email 86394 0
kate.smith@uwa.edu.au
Contact person for public queries
Name 86395 0
Ms Christianne White
Address 86395 0
M577, University of Western Australia, 35 Stirling Hwy Crawley Western Australia 6009
Country 86395 0
Australia
Phone 86395 0
+61 08 9224 4515
Fax 86395 0
Email 86395 0
wacha@uwa.edu.au
Contact person for scientific queries
Name 86396 0
Dr Kate Smith
Address 86396 0
M577, University of Western Australia, 35 Stirling Hwy Crawley Western Australia 6009
Country 86396 0
Australia
Phone 86396 0
+61 08 9224 4518
Fax 86396 0
Email 86396 0
kate.smith@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
From publication to 10 years post publication.
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.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Subject to proposal approvals and signing of data access agreement, via secure transfer.
What supporting documents are/will be available?
No other documents available
Summary results
No Results