Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001126707
Ethics application status
Approved
Date submitted
1/08/2022
Date registered
16/08/2022
Date last updated
16/08/2022
Date data sharing statement initially provided
16/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Bootcamp Frontiers: a behaviour change intervention targeting dementia risk and cognition for rural and remote older adults
Scientific title
Brain Bootcamp Frontiers: a randomised waitlist-controlled trial of a behaviour change intervention targeting dementia risk and cognition for rural and remote older adults
Secondary ID [1] 306618 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia risk 325537 0
Cognition 325538 0
Condition category
Condition code
Public Health 322908 322908 0 0
Health promotion/education
Neurological 322909 322909 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brain Bootcamp Frontiers is a lifestyle intervention targeting behaviour change for multiple dementia risk factors. Specifically we are targeting diet, physical activity, social connections and cognitive stimulation. This will be completed in three ways:

1) Appraisal of their existing performance as identified through our brain health survey and cognition assessment;

2) Goal-setting techniques and suggestions:
This involves providing participants with an information booklet of suggestions/activities on how to adopt a brain healthier lifestyle within their Frontiers box that is delivered to their door upon completion of the online survey. Within the booklet there will also be removable, paper-based, goal planning, goal tracking and evaluation sheets for them to use across the course of the 9 month intervention. These materials have been designed specifically for the Frontiers study. Instructions on how to use the goal planner, goal tracker and information booklet are also provided and encourage the participant to set one goal each week. It will take participants approximately 5 minutes to set a goal each week and 10 minutes at the end of every 3 months to fill out their evaluation sheet. This goal should be focused on one targeted lifestyle factor e.g., diet, physical activity, cognitive stimulation and social activity. The goal planner reminds participants to make sure they are changing the focus of their goal to different lifestyle factors each week. Participants will be asked to send their goal planning and tracking sheets back to the researchers using the reply paid envelope included in their Frontiers box to allow researchers to monitor adherence to the program. At the end of every 3 months they will be asked to complete an online survey of their brain health and be provided with a summary of how they have progressed via email.

3) Cued physical prompts for them to use to support behaviour change;
This involves providing participants with a physical items that represent each of the lifestyle factors within the Frontiers box. These materials have been designed specifically for the Frontiers study. For diet there is olive oil to prompt them towards a Mediterranean way of eating; for cognitive stimulation there is a set of brain teaser cards; for physical activity, there is a pedometer; and for social activity there are dates for holidays and national days to celebrate and suggestions for remaining socially active. There is a removable, paper-based evaluation sheet included in the information booklet at the end of every 3 months for participants to record the prompts they used, activities they did and how long they spent doing them. Participants will send these back in the reply paid envelope along with the goal planning and goal tracking sheets at the end of the 9 month program.

Registered participants will participate in a randomised, single-blind, 3-month waitlist-controlled trial. Participants will be randomised into 2 groups. For Arm 1, the intervention (Frontiers box including goal setting techniques and suggestions and cued physical prompts) will be delivered to their door after completing a 30 minute online survey and 15 minute cognitive assessment over the phone at baseline. They will then proceed with their 6 month and 9 month follow-up surveys as well as their 15 minute telephone cognitive assessments.

At the end of the intervention period the first 15-20 participants from each arm who provided consent to be contacted for an evaluation interview will be contacted by researchers to schedule a semi-structured individual interview for an impact/outcome evaluation.
Intervention code [1] 323059 0
Lifestyle
Intervention code [2] 323060 0
Prevention
Intervention code [3] 323061 0
Behaviour
Comparator / control treatment
There will be a 3 month waitlist-controlled comparison group. This group will continue with their standard care for the first 3 months of the intervention. In this case, standard care refers to the participants continuing to manage their health as usual (e.g., going to the GP when ill). They will be required to complete the 30-minute survey at baseline and their 15 minute cognitive assessment over the phone, however they will not take part in the intervention for the first 3 months.

At 3-months, this group will complete the survey again as well as their 15 minute cognitive function assessment over the phone and receive the intervention (Frontiers box) and view their risk profile. They will then proceed with their 3 month and 6 month and 9 month follow-up surveys as well as their 15 minute telephone cognitive assessments.

At the end of the intervention period the first 15-20 participants from each arm who provided consent to be contacted for an evaluation interview will be contacted by researchers to schedule a semi-structured individual interview for an impact/outcome evaluation.
Control group
Active

Outcomes
Primary outcome [1] 330689 0
Proportion of older adults with change in brain health risk scores as measured by the LIfestyle for BRAin health (LIBRA) index
Timepoint [1] 330689 0
Intervention: 0 months (baseline), 3 months (primary timepoint), 6 months, (post-commencement of intervention), 9 months (end of intervention)
Waitlist: 0 months (pre-intervention), 3 months (baseline), 6 months (primary timepoint), 9 months (post-commencement of intervention), 12 months (end of intervention)
Secondary outcome [1] 407222 0
Proportion of older adults with changes in dementia literacy as measured by an adapted dementia awareness questionnaire from Heger et al, including items from UK's British Social Attitudes Questionnaire
Timepoint [1] 407222 0
Intervention: 0 months (baseline), 3 months (primary timepoint), 6 months, (post-commencement of intervention), 9 months (end of intervention)
Waitlist: 0 months (pre-intervention), 3 months (baseline), 6 months (primary timepoint), 9 months (post-commencement of intervention), 12 months (end of intervention)
Secondary outcome [2] 407223 0
Proportion of older adults with changes in cognition as measured by the Telephone Interview for Cognitive Status-Modified (TICS-M)
Timepoint [2] 407223 0
Intervention: 0 months, 3 months (primary timepoint), 9 months
Waitlist: 0 months (pre-intervention), 3 months (baseline), 6 months (primary timepoint), 12 months (end of intervention)
Secondary outcome [3] 412868 0
Feasibility and acceptability of the study will be measured using 30 minute semi-structured, one-one one telephone interviews with a member of the research team. This is a composite outcome.
Timepoint [3] 412868 0
Intervention: 9 months (end of intervention)
Waitlist: 12 months (end of intervention)

Eligibility
Key inclusion criteria
Population-based sample of older adults aged over 55 years and older.
Access to the internet in order to complete the online assessments.
Older adults residing in rural and remote areas according to the Australian Standard Geographical Classification System (ASGC).
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with an active episode of major depression, an existing diagnosis of dementia, inability to provide informed consent, or are currently enrolled in any lifestyle change intervention.

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 concealment will be achieved by utilising an external computer system to assign each participant with a unique identifier. The program will be controlled by an independent researcher to minimise the risk of unbalanced assignment to either group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study will use a block randomisation procedure using computer software (i.e. computerised sequence generation) to assign a unique ID. Blocks of several sizes (4, 6 and 8) will be used. Block size and randomisation pattern will be randomly chosen at the beginning of each block. Blocks will be stratified by postcode to prevent early exposure to the intervention within the waitlist group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a waitlist-controlled design. Both arms of the intervention will receive the intervention at different times.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size was determined based on previous intervention studies of dementia risk reduction programs with the LIBRA index as an outcome measure , as well as unpublished data from the original Brain Bootcamp study, where a significant mean difference in LIBRA index scores between baseline and 3 months following the intervention of -1.43 points was found. Recent evidence further simulated “small,” “medium,” and “large” intervention effects between-group differences of the LIBRA index as -0.19, -0.31, and -0.52 respectively. To observe a large interventional effect (-0.52) in this study, we will require a sample size of 62 participants, using an 80% statistical power and a 5% maximum probability of type 1 error alpha. This sample size was calculated using the t-test package of the Rstudio software (power.t.test) and was rounded to 200 based on the intervention resources we have available and to account for a possible 30% attrition rate at each time point.

Descriptive analysis of baseline profile of participant demographics (e.g., age, gender, socioeconomic status, medical conditions) and outcome measures (e.g., dementia risk, dementia literacy, cognitive performance) will be presented.

To test for differences in the primary (dementia risk) and secondary outcome variables (cognitive ability, dementia literacy) of the intervention group and waitlist-control group, analysis of covariance (ANCOVA) will be performed, with the outcomes of the T2 assessment (i.e., measured at 3 months, after this period the waitlist-control group will commence with the intervention). The outcomes assessed at the T2 follow-up will be included in the model as dependent variables and groups as between-subject variables. Potential baseline differences between the treatment arms will be included as covariates if necessary.

To test for changes in primary and secondary outcome measures over the total study period, data from the intervention group and waitlist-control group will be analysed using a linear mixed model. This model will estimate the fixed effects of the regression slopes representing any changes during the time intervals (i.e., T0–T1, T1–T2 for the intervention and waitlist-control group) to provide insight into whether effects of the outcome variable will be sustained.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/08/2022
Actual
Date of last participant enrolment
Anticipated
24/10/2022
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310951 0
University
Name [1] 310951 0
Macquarie University
Country [1] 310951 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
75 Talavera Rd, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 312254 0
None
Name [1] 312254 0
Address [1] 312254 0
Country [1] 312254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310510 0
Macquarie University Human Research Ethics Committee: Medical Sciences
Ethics committee address [1] 310510 0
Balaclava Rd, Macquarie Park NSW 2109
Ethics committee country [1] 310510 0
Australia
Date submitted for ethics approval [1] 310510 0
18/03/2022
Approval date [1] 310510 0
12/05/2022
Ethics approval number [1] 310510 0
11336

Summary
Brief summary
A mixed method, waitlist-randomised controlled trial with 200 older adults in rural and remote areas in Australia will be conducted. The aim of the program is to implement an intervention to improve dementia risk, dementia awareness and cognition. Participants will be assigned to either the multidomain behaviour change group or a waiting-list control group and assessed when they initially register for the program, 3 and 9 months after the intervention. The waiting-list control group will receive the intervention after 12 weeks. The primary outcome is dementia risk score, measured by the LIBRA index. Secondary outcomes include dementia awareness and cognitive performance. An impact/outcome evaluation, which will involve semi-structured interviews, will be conducted at the end of the trial including participants from both multidomain behaviour change group and control groups to examine the feasibility and acceptability of the intervention.
The aim of this intervention is to increase awareness of dementia, decrease risk of dementia through reducing lifestyle factors and improve brain health in the long-term.
Trial website
brainbootcamp.com.au/registration
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117906 0
Ms Laura Dodds
Address 117906 0
Australian Institute of Health Innovation, Macquarie University, 75 Talavera Rd, Macquarie Park NSW 2113
Country 117906 0
Australia
Phone 117906 0
+61 432487857
Fax 117906 0
Email 117906 0
laura.dodds@mq.edu.au
Contact person for public queries
Name 117907 0
Dr Joyce Siette
Address 117907 0
MARCS Institute for Brain, Behaviour and Development, Hawkesbury Rd, Westmead NSW 2145
Country 117907 0
Australia
Phone 117907 0
+61 2 9772 6648
Fax 117907 0
Email 117907 0
joyce.siette@westernsydney.edu.au
Contact person for scientific queries
Name 117908 0
Dr Joyce Siette
Address 117908 0
MARCS Institute for Brain, Behaviour and Development, Hawkesbury Rd, Westmead NSW 2145
Country 117908 0
Australia
Phone 117908 0
+61 2 9772 6648
Fax 117908 0
Email 117908 0
joyce.siette@westernsydney.edu.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 is only being collected for the purposes of this study. Researchers do not intend to share this information with other parties.


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.