None listed
Conditions
Brief summary
It is currently estimated that approximately 35% of all dementias can be attributed to risk factors that are highly modifiable, including low mood, poor sleep, poor heart health and low cognitive/social engagement. The BetterBrains trial will test whether remotely delivered (via online, telephone and smartphone application) person-centred education and lifestyle behaviour change strategies, targeted at modifying these four risk factor clusters, can prevent cognitive decline in middle-aged adults aged between 40 – 70 years. The trial will recruit 1510 people living in the community throughout Australia. Of these people, 755 participants will be randomised to the intervention group and will receive the personalised BetterBrains program, while the other 755 participants will receive health education materials about dementia risk reduction. We hypothesise that a higher proportion of participants randomised to the BetterBrains program will show a favourable cognitive outcome at 24-months than those randomised to the control group.
Interventions
The BetterBrains intervention will be delivered remotely by clinicians (i.e., registered psychologists, physiotherapists, social workers or occupational therapists; henceforth referred to as BetterBrains Coaches) trained in motivational interviewing and behaviour change strategies. The BetterBrains intervention incorporates: (1) online risk factor screening; (2) telephone-based goal setting, coaching, and follow-up support, health care provider communication and community linkage for management of identified risk factors; and (3) provision of health education regarding dementia risk reduction; and (4) smartphone-app support to assist participants in undertaking their recommended intervention. The risk management pathway and person-centered approach of the BetterBrains intervention, means that the content, duration and frequency of the intervention provided to each participant will be unique. Participants will receive a minimum of 6 scheduled calls from their coach (3 calls over 6 weeks after baseline and 3 calls over 6 weeks at 6 months). The risk factor assessment is expected to take 40 minutes to complete. The intervention program will be implemented over 12 months with participants followed up for a further 12 months (24 months total). A detailed program evaluation will be conducted concurrently to the RCT to assess intervention adherence and fidelity. Below we outline each of the components and how this will be assessed for adherence/intervention fidelity. (1) Online risk factor screening Study participants will visit the BetterBrains study website and complete a risk factor screening assessment. The risk factor assessment comprises of 10 validated questionnaires, as well as review of participant demographic and medical/health histories, which map onto 4 risk domains each of which have a robust evidence base for dementia risk reduction: sleep (Epworth Sleepiness Scale (ESS); Insomnia Sleep Index (ISI); Pittsburgh Sleep Quality Index (PSQI)), cardiovascular health (including physical inactivity) (International Physical Activity Questionnaire (IPAQ); Medical/health history (including smoking and alcohol intake), social/cognitive engagement (Relationships Questionnaire; Educational and Occupational History) and mental health (Depression, Anxiety and Stress Scale (DASS) (21-item); Centre for Epidemiological Studies (Depression Scale), Hospital Anxiety and Depression Scale (HADS)). Evaluation: Number of registrations and completed risk factor screening assessments. (2) Goal setting, coaching, and follow-up telephone support for management of identified risk factors Over a 12-month time period commencing after completion of the participant’s risk factor and baseline assessment, BetterBrains coaches will provide education and coaching to participants in the intervention group via telephone calls. Participants will receive a minimum of 6 scheduled calls from their coach. We expect that the average duration of the initial BetterBrains consultation call will be approximately 30 minutes, with all other BetterBrains coaching calls thereafter lasting approximately 15-20 minutes (on average). Coaching in these telephone calls will focus on person-centred care to optimise participant engagement. Motivational interviewing will be used to support the participant to understand the findings of their risk assessment and to facilitate guided goal-setting based on the participant’s identified risk factors. Anticipated barriers to engagement (e.g., work and/or family commitments) will also be identified, and coaches will assist participants to find solutions to these perceived barriers. Further, coaches will also assist participants by recommending action strategies to meet specified goals, and assist with finding appropriate support services and resources local to the participant’s residential area (community linkages). Evaluation: Identification of barriers and enablers to implementation from the perspectives of the BetterBrains coaches and participants in the trial, through participant surveys, monitoring of the online discussion forums, and interviews with the BetterBrains coaches. Analysis of participant risk factors and intervention strategies selected and completed as per BetterBrains coaches website records. Assessment of the degree to which BetterBrains was implemented as planned (implementation fidelity and adherence) assessed via multiple data sources (e.g., intervention documentation, including number of phone calls, smartphone app engagement, recordings/monitoring of BetterBrains coach calls). (3) Provision of health education regarding dementia risk reduction All participants will receive written monthly updates on general news about dementia and Alzheimer’s disease, and general psychoeducational health material about dementia risk reduction, in the form of educational blog posts, termed ‘BrainBlog’ (information will be presented in a variety of medium, including written, pictorial diagrams, and/or videos). The BrainBlog will be produced by the investigator team explicitly for study purposes. It is anticipated that participants will engage with this material for approximately 15-20 minutes (on average) each month for as long as the trial is active (a minimum of 24-months). The BrainBlog will be available to all participants and will not contain any personalised recommendations or information. All participants will also be provided with additional (optional) further reading material, which we estimate participants will engage with for an added 30-40 minutes. Material will simultaneously be available on the BetterBrains website and smartphone app. Evaluation: Engagement via web analytics with smartphone app, webpage and the BrainBlog. (4) Smartphone app support If participants have a smartphone, they will be encouraged to download the BetterBrains app. The BetterBrains app will be used to assist participants in the intervention group in undertaking their recommended intervention (through weekly goal check-ins), and in the assessment of engagement and barriers to engagement. Intervention participants will receive goal check-in alerts weekly from their first intervention phone call up until week 52 of the intervention. Both intervention and control group participants will also receive a general health check-in monthly, also administered through the app. Both intervention and control group participants will also be able to communicate more readily with research team members via the app (internal message system, schedule calls, see upcoming calls). As the BetterBrains app is an optional component of the intervention intended to enhance participant experience and engagement with the clinical/research team, minimum or expected participant time spent using the app has not been specified nor estimated and will be entirely up to the discretion of the participant. Evaluation: Useability, from the perspectives of the BetterBrains coaches and participants will be explored via participant surveys, monitoring of the online discussion forums, and interviews with the BetterBrains coaches including app and website analytics. Frameworks used to evaluate program acceptability include: Acceptability of Intervention Measure, Intervention Appropriateness Measure and Feasibility of Intervention Measure, as well as the Unified Theory of Acceptance and Use of Technology 2.
Sponsors
Study design
Eligibility
Inclusion criteria
Community-dwelling persons, aged 40 to 70 years, fluent in the English language and who have: a first- or second-degree family history of Alzheimer's disease or dementia, resided in Australia for at least 2 years, access to a laptop or desktop computer, are willing to provide informed consent and a saliva sample for genotyping, and have at least one modifiable risk factor for dementia as identified during the online screening process, will be recruited.
Exclusion criteria
Exclusion criteria for both the control and intervention group are: a diagnosis of Alzheimer’s disease, Parkinson’s disease, Dementia with Lewy Bodies or other known diagnosis of dementia; use of TGA approved medication for the treatment of Alzheimer’s disease (e.g., donepezil, galantamine, rivastigmine, or other newly approved medication); use of any TGA approved medications for the treatment of Parkinson’s disease (e.g., sinemet, amantadine, bromocriptine, pergolide, selegiline, or other newly approved medication); history of severe traumatic brain injury or other significant neurological disease or insult (e.g., Multiple Sclerosis, Stroke); diagnosis of a major psychiatric condition (e.g., schizophrenia, uncontrolled major depressive disorder); history of alcohol or substance abuse or dependence within the past 2 years; regular (daily) use of narcotics or antipsychotic medication; history of myocardial infarction in the past year or unstable severe cardiovascular disease including angina with congestive heart failure symptoms at rest; diagnosis of epilepsy; respond “no, and I have no intention to make changes” in response to the question “have you made any changes to your lifestyle during the past year to actively reduce your risk of dementia (e.g., increasing physical activity, engaging in cognitively stimulating activities, lowering stress)?”