Trial Review

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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
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 12 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 and 12 months.
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 and 12 months.
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 and 12 months.
Secondary outcome [1] 352300 0
Change in blood pressure - using an automatic blood pressure monitor
Timepoint [1] 352300 0
Baseline 6 and 12 months.
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 and 12 months.
Secondary outcome [3] 352750 0
Health Economic Costing through health data linkage and documentation of resources used throughout the study
Timepoint [3] 352750 0
12 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 and 12 months.
Secondary outcome [5] 368952 0
Blood glucose control measured as glycated haemoglobin (HbA1c) from fasted blood test
Timepoint [5] 368952 0
Baseline, 6 and 12 months.
Secondary outcome [6] 368954 0
Body weight and body composition using bioimpedance scales
Timepoint [6] 368954 0
baseline 6 and 12 months.
Secondary outcome [7] 368955 0
Waist and hip girths measured with constant tension tape
Timepoint [7] 368955 0
Baseline, 6 and 12 months.
Secondary outcome [8] 368956 0
Smoking status and alcohol intake from KICA smoking and alcohol questionnaires
Timepoint [8] 368956 0
Baseline, 6 and 12 months.
Secondary outcome [9] 368957 0
Functional capacity through step test for balance (Hill, 1996);
Timepoint [9] 368957 0
Baseline; 6 months, 12 months after intervention commencement
Secondary outcome [10] 368958 0
Regular physical activity levels through RAPA questionnaire (Rapid Assessment of Physical Activity)
Timepoint [10] 368958 0
Baseline; 6 months, 12 months after intervention commencement
Secondary outcome [11] 368959 0
Cognitive performance measured via Hopkins Verbal Learning Test,
Timepoint [11] 368959 0
Baseline; 6 months, 12 months after intervention commencement
Secondary outcome [12] 368960 0
Cognitive performance measured by Colour Trails test,
Timepoint [12] 368960 0
Baseline; 6 months, 12 months after intervention commencement
Secondary outcome [13] 368961 0
Cognitive performance measured by Symbol Digit Modalities test,
Timepoint [13] 368961 0
Baseline; 6 months, 12 months after intervention commencement
Secondary outcome [14] 368962 0
Anxiety and depression status via GAD7 and KICA questionnaires.
Timepoint [14] 368962 0
Baseline; 6 months, 12 months after intervention commencement
Secondary outcome [15] 401058 0
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.
Timepoint [15] 401058 0
6, and 12 months.
Secondary outcome [16] 401059 0
2-minute walk test of cardiovascular fitness. Included prior to enrolment.
Timepoint [16] 401059 0
Baseline, 6 and 12 months
Secondary outcome [17] 401060 0
Sit to Stand Test - Timed 5 sit stands. Added prior to enrolment in the main study.
Timepoint [17] 401060 0
baseline, 6 and 12 months
Secondary outcome [18] 401061 0
Timed Up And Go test of mobility.
Added prior to enrolment in the main study.
Timepoint [18] 401061 0
baseline, 6 and 12 months.
Secondary outcome [19] 401062 0
Hand Grip strength measured with dynamometer.
Added before enrolment in the main study.
Timepoint [19] 401062 0
Baseline, 6 and 12 months.
Secondary outcome [20] 401063 0
The Montreal Cognitive Assessment (MoCA)
Timepoint [20] 401063 0
Baseline, 6 and 12 months

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);
Minimum age
45 Years
Maximum age
90 Years
Sex
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, 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
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
14/10/2020
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
70
Accrual to date
30
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
Recruitment postcode(s) [4] 39302 0
6147 - Langford

Funding & Sponsors
Funding source category [1] 300456 0
Government body
Name [1] 300456 0
National Health and Medical Research Council
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
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
Ethics committee name [2] 309474 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 309474 0
Ethics committee country [2] 309474 0
Australia
Date submitted for ethics approval [2] 309474 0
22/10/2018
Approval date [2] 309474 0
07/11/2018
Ethics approval number [2] 309474 0
RA/4/20/4944

Summary
Brief summary
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
[email protected]
Contact person for public queries
Name 86395 0
Alex Lalovic
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
[email protected]
Contact person for scientific queries
Name 86396 0
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
[email protected]

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 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.