Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000165886
Ethics application status
Approved
Date submitted
26/12/2020
Date registered
17/02/2021
Date last updated
17/02/2021
Date data sharing statement initially provided
17/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain Bootcamp: the effect of a behaviour change intervention on brain health in older adults
Scientific title
Brain Bootcamp: Pre-post evaluation of a behaviour change intervention to promote healthy brain ageing in older adults
Secondary ID [1] 302932 0
None
Universal Trial Number (UTN)
U1111-1262-1814
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Dementia risk 319954 0
Awareness of dementia risk factors 319955 0
Condition category
Condition code
Neurological 317890 317890 0 0
Dementias
Public Health 317891 317891 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brain Bootcamp is a pre-post trial that will be conducted in Sydney. Participants aged over 65 years old living independently in the community are asked to generate a brain health risk profile (calculated using the LIBRA index) at baseline and assess change therein at three month follow-up.

The intervention has multiple facets. It uses goal-setting for behaviour, education awareness and prompts to reduce brain health risk among older adults.

During the intervention, participants will receive in the mail a resource pack containing their individual risk profile, educational booklet on dementia risk factors (designed specifically for this study) and five physical items designed to prompt physical, social and mental activity, and better nutrition. These items are a calendar, a pedometer, one olive oil jar, one balsamic vinegar jar and one pack of brain teaser cards. These will be delivered individually to each participant. The intervention will only occur once.

Please note that the booklet will be personalised to reflect the individual dementia risk profile (based on their response to the questionnaire). This is to support the goal setting process where each adult is asked to provide attainable goals in a way that benefits themselves (e.g., if physical activity was highlighted as poor and contributed to their high dementia risk, then the individual will be asked to write a goal for physical activity in their booklet e.g., 8000 steps a day).

The participant's dementia risk profile is calculated using the ’LIfestyle for BRAin health’’ (LIBRA) index, which is shown to be a valid predictor of the development of dementia. The index is a weighted compound score of 12 modifiable risk and protective factors (i.e., hypertension, obesity, high cholesterol, diabetes, coronary heart disease, chronic kidney disease, physical inactivity, alcohol intake, smoking, depression, diet and cognitive activity), that can be targeted by lifestyle interventions and vascular risk management in primary care.

Intervention adherence will not be assessed.

Intervention code [1] 319216 0
Lifestyle
Intervention code [2] 319217 0
Prevention
Comparator / control treatment
Baseline assessments are completed only.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325905 0
’LIfestyle for BRAin health’’ (LIBRA) index, which is shown to be a valid predictor of the development of dementia. The index is a weighted compound score of 12 modifiable risk and protective factors (i.e., hypertension, obesity, high cholesterol, diabetes, coronary heart disease, chronic kidney disease, physical inactivity, alcohol intake, smoking, depression, diet and cognitive activity), that can be targeted by lifestyle interventions and vascular risk management in primary care. LIBRA ranges from -5.9 to +12.7, with higher scores indicating greater dementia risk

The LIBRA index has been developed as an instrument to show an individual’s potential for dementia prevention based on epidemiological evidence for dementia risk factors and expert Delphi consensus and has been validated against large, international longitudinal cohort studies. The index has also been shown to be a suitable intermediate outcome for trials.
Timepoint [1] 325905 0
Data will be collected on the following variables at baseline and three months later from all participants
Secondary outcome [1] 389472 0
Dementia awareness and literacy will be measured with a previously used questionnaire adapted from the MijnBreincoach public health campaign. This 22-item questionnaire includes ten items from the UK’s British Social Attitudes (BSA) survey, covering self-reported knowledge of dementia, general statement on the possibility of dementia risk reduction, personal experience with individuals with dementia, dementia risk awareness and knowledge of 14 modifiable dementia risk and protective factors (i.e., hypertension, smoking, physical activity, depression, diabetes, obesity, coronary heart disease, chronic kidney disease, hypocholesteraemia, mental activity, low to moderate alcohol intake, healthy diet, midlife hearing loss and social connections). In addition, three sham factors will be included (use of painkillers, personal hygiene and having children) to check for monotone answering tendency. Additional items will ask for other factors’ respondents consider to be related to dementia risk motivation. Participants will be asked to what extent they agree or disagree on a 5-point Likert scale ranging from ‘strongly disagree’ to ‘strongly agree’.
Timepoint [1] 389472 0
Baseline, 3 months post-intervention
Secondary outcome [2] 389473 0
Quality of life: will be measured using the EQ-5D-5L scale. It consists of a self-administered health index and a 100-point visual analogue scale (VAS), for participants to rate their current health state from 0 as their ‘worst imaginable health state’ to 100, their ‘best imaginable health state’.

The instrument covers mobility, self-care, pain/discomfort, usual activities and anxiety/depression. Utility scores are quantified along a continuum that ranged from -0.59 (worst health) to 1.00 (perfect health). It has demonstrated convergent validity and good reliability for individuals with diverse health conditions.
Timepoint [2] 389473 0
Baseline, 3 months post-intervention
Secondary outcome [3] 389474 0
Social networks: will be measured using the 6-item version of the Lubben Social Network Scale (LSNS-6). Internal reliability (0.83) is good and the two sub-scales (family and friendships) both demonstrate high levels of internal consistency. Scores range from 0-30 with higher scores indicating more social engagement and scores <12 identifying individuals at risk of social isolation.
Timepoint [3] 389474 0
Baseline, 3 months post-intervention
Secondary outcome [4] 389475 0
Motivational attitudes and beliefs to modify lifestyle specific to dementia risk reduction will be measured using Motivation to Change Lifestyle and Health Behaviour for Dementia Risk Reduction (MCLHB-DRR). This is a 27-item tool, commonly used in the evaluation of dementia prevention programs. It has been validated amongst individuals aged 50 and over with moderate to high internal reliability and test-retest reliability. Additional questions on individual capabilities and opportunities will also be asked.
Timepoint [4] 389475 0
Baseline 3, months post-intervention

Eligibility
Key inclusion criteria
Inclusion criteria include community-dwelling individuals aged 65 years or more (n=1000) on date of consent, literate in English and have access to the internet in order to complete the online assessments.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include individuals with a self-reported active episode of major depression and/or 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
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an exploratory study and sample size was not calculated. This trial will be used to determine what a good effect size will be for a future multicentre national trial.

Descriptive statistics will be computed for participant demographics and all outcomes measures. Where appropriate, multiple imputation will be used to manage missing data. Multilevel mixed models will be used to investigate changes in LIBRA index, dementia awareness, social networks and quality of life over time. The primary outcome, LIBRA index, will be analysed using a multilevel mixed effects regression model, with covariates added to the model in various stages, and only those significant at the a <.05 level will remain in the model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/01/2021
Date of last participant enrolment
Anticipated
1/05/2021
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
1000
Accrual to date
550
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 307352 0
Government body
Name [1] 307352 0
NSW Government, My Community Project Grant
Country [1] 307352 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Level 6, 75 Talavera Rd, Macquarie University, NSW, 2109
Country
Australia
Secondary sponsor category [1] 307993 0
None
Name [1] 307993 0
Address [1] 307993 0
Country [1] 307993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307439 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 307439 0
Ethics committee country [1] 307439 0
Australia
Date submitted for ethics approval [1] 307439 0
07/10/2020
Approval date [1] 307439 0
17/12/2020
Ethics approval number [1] 307439 0
52020917422912

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

Contacts
Principal investigator
Name 107242 0
Dr Joyce Siette
Address 107242 0
Australian Institute of Health Innovation
Level 6, 75 Talavera Rd, Macquarie University, NSW 2109
Country 107242 0
Australia
Phone 107242 0
+61 2 9850 2456
Fax 107242 0
Email 107242 0
joyce.siette@mq.edu.au
Contact person for public queries
Name 107243 0
Joyce Siette
Address 107243 0
Australian Institute of Health Innovation
Level 6, 75 Talavera Rd, Macquarie University, NSW 2109
Country 107243 0
Australia
Phone 107243 0
+61 2 9850 2456
Fax 107243 0
Email 107243 0
joyce.siette@mq.edu.au
Contact person for scientific queries
Name 107244 0
Joyce Siette
Address 107244 0
Australian Institute of Health Innovation
Level 6, 75 Talavera Rd, Macquarie University, NSW 2109
Country 107244 0
Australia
Phone 107244 0
+61 2 9850 2456
Fax 107244 0
Email 107244 0
joyce.siette@mq.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


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.