Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001088538
Ethics application status
Approved
Date submitted
5/07/2024
Date registered
10/09/2024
Date last updated
10/09/2024
Date data sharing statement initially provided
10/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical Activity for Better Health and Drive (PhABHeadD)
Scientific title
The effect of concurrent physical and cognitive training in cognitively healthy older adults aged 60-75 years on driving skills and cognitive function: The Physical Activity for Better Health and Drive (PhABHeaD) study
Secondary ID [1] 307581 0
Nil known
Universal Trial Number (UTN)
U1111-1280-3851
Trial acronym
PhABHeaD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy ageing 327632 0
Cognitive function 334394 0
Condition category
Condition code
Mental Health 324762 324762 0 0
Studies of normal psychology, cognitive function and behaviour
Physical Medicine / Rehabilitation 331335 331335 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The concurrent training arm will comprise of participant engaging in simultaneous cognitive and physical training. Participants will be cycling on a stationary cycle ergometer whilst engaging in specific cognitive tasks though BrainHQ software on a Microsoft Surface tablet. Participants will be cycling at above 60% of their age predicted heart rate maximum for 50 minutes with a 3-minute warm-up and cool-down period either side (56 minutes total). Both the physical and cognitive components of the intervention will be delivered by an appropriately qualified exercise professional with experience working with the target population and will be delivered face-to-face where participants attend the University of Canberra to complete the intervention. In total, participants will complete 24 x 50-minute sessions as 2 per week for 12 weeks. The use of a heartrate-based method for intensity will incite progressive overload for the physical component. Similarly, the BrainHQ software is adaptive and will allow for participants to progressively increase the difficulty of cognitive tasks throughout the intervention as they improve. Therefore, despite all participants completing the same duration and number of sessions, each individual’s experience will be slightly personalised based on both physical and cognitive capabilities. Each session, participants will complete up to 4 separate cognitive tasks within the BrainHQ software of a total of 6 tasks that will rotate between sessions, including: target tracker, eye for detail, double decision, scene crasher, mind bender and mental map which are detailed on BrainHQ's website https://v4.brainhq.com/
Intervention code [1] 324458 0
Lifestyle
Comparator / control treatment
There are two control groups assocociated with this study, physical only training and cognitive only training.

Physical only:
The physical only training arm will comprise of participants cycling on a stationary cycle ergometer whilst watching low cognitively engaging YouTube videos on a Microsoft Surface tablet from a preset video playlist. Participants will be asked to cycle at above 60% of their age predicted heart rate maximum for 50 minutes with a 3-minute warm-up and cool-down period either side (56 minutes total). The intervention will be delivered by an appropriately qualified exercise professional with experience working with the target population and will be delivered face-to-face where participants attend the University of Canberra to complete the intervention. In total, participants will complete 25 x 50-minute sessions as 2 per week for 12 weeks. The use of the heartrate-based method for intensity will incite progressive overload as participants fitness will increase, requiring greater effort to increase heartrate. As the intervention is heartrate based for intensity, whilst the baseline requirement is the same, each participants experience will be slightly personalised based on physical capabilities.

Cognitive only:
The cognitive only training arm will comprise of participants sitting in a quiet room, engaging in cognitive training using BrainHQ software on a Microsoft Surface tablet. Participants will complete up to 5 different cognitive tasks during each training session of a total of 8 tasks that will rotate between sessions. Each session will be 50 minutes in length of engaging in cognitive tasks and will be delivered face-to-face at the University of Canberra, twice per week for 12 weeks (24 total sessions). The cognitive intervention will be delivered by an appropriately qualified exercise professional. The BrainHQ software is adaptive in nature such that when participants improve at any given task, it will get more difficult. Inversely, the tasks will get easier if participants struggle at the current level. This type of software addresses limitations of previous concurrent training literature where the progressive overload method was not implemented within the cognitive training component of the research. Each session, participants will complete up to 4 separate cognitive tasks within the BrainHQ software of a total of 6 tasks that will rotate between sessions, including: target tracker, eye for detail, double decision, scene crasher, mind bender and mental map which are detailed on BrainHQ's website https://v4.brainhq.com/
Control group
Active

Outcomes
Primary outcome [1] 332583 0
Driving skills
The driving simulator is a custom designed driving simulator by Hyperdrive to resemble the interior of a regular car. It has three pedals, a gear shifter, indicators, and a steering wheel. The simulator software is running on SCANER by AVSimulation, and other road users (apart from the participant) are programmed to respond in an intelligent way to changes in the environment. The driving environment appears on three screens, providing 180-degree peripheral vision.

Driving outcome 1 – reaction to traffic lights and scenarios
Participants will be asked to respond to traffic lights changing amber within task one. Participants will encounter six Intersections with different traffic regulations, including 2 sets of traffic lights and will be instructed to drive straight on each intersection and to comply with the traffic regulations. Additionally, at a certain point between two intersections a parked car will suddenly drive onto the road, close in front of the participant (with a time headway of 3 s).
Timepoint [1] 332583 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Primary outcome [2] 332584 0
Primary cognitive outcomes
Driving outcome 2 – average speed on road
During task one, , the average speed on road sections with different speed limits will be measured. There will be four road sections with a length of approximately 700 m each, two with a speed limit of 60 km/h and two with a speed limit of 80 km/h.
Timepoint [2] 332584 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Primary outcome [3] 338833 0
Driving outcome 3 – time headway
For task 2, participants begin In an acceleration lane and will be Instructed to merge Into the traffic on the motorway, overtake a car and return to the left hand lane. Traffic in the right-hand lane adopted a preferred distance to the car in front of them. This distance will Increase for each consecutive car, making overtaking easier over time. Finally, participants will be instructed to leave the motorway and stop the car. Distance to other road users will be assessed by using the following measures during the overtaking manoeuvre: the time headway between the participant and the car in front of them, the time headway adopted by the car behind the participant, and the degree of deceleration of the car behind the participant.
Timepoint [3] 338833 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [1] 413971 0
Primary Outcome 4
Driving outcome 4 – Standard deviation of lateral position and speed
During driving task 3, participants will be asked to drive along a straight road without any other traffic or distractions. The participant will be asked to drive along the road at a consistent speed of 100km/h for 10 minutes. Sustained vehicle control was assessed by using the following measures: standard deviation of lateral position, the standard deviation of speed and the average speed.
Timepoint [1] 413971 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [2] 437633 0
Primary Outcome 5
Episodic memory – NIH Picture sequence memory test Form A
One cognitive primary outcome will be episodic memory. This cognitive domain was selected based on previous research showing that cognitive training benefits most episodic memory. Assessing episodic memory will enable comparison of the relative contribution of each intervention and their hypothesised synergistic effects. This outcome will be assessed with the US national Institute of Health (NIH) toolbox, with the NIH picture sequence memory test Form A.
Timepoint [2] 437633 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [3] 437634 0
Primary Outcome 6
Speed of processing – NIH Oral symbol digit test
The other primary cognitive primary outcome will be speed-of-processing. This cognitive domain was selected based on previous research showing that physical activity training benefits speed-of-processing most. Assessing this domain will enable an explicit comparison of the relative contribution of each intervention and their hypothesised synergetic effects. This outcome will be assessed with the US national Institute of Health (NIH) toolbox, oral symbol digit test.
Timepoint [3] 437634 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [4] 437635 0
Primary Outcome 7
Speed of processing – NIH Pattern comparison test
The other primary cognitive primary outcome will be speed-of-processing. This cognitive domain was selected based on previous research showing that physical activity training benefits speed-of-processing most. Assessing this domain will enable an explicit comparison of the relative contribution of each intervention and their hypothesised synergetic effects. This outcome will be assessed with the US national Institute of Health (NIH) toolbox, pattern comparison test
Timepoint [4] 437635 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [5] 437636 0
Secondary cognitive outcomes – Global cognition
Global cognition will be assessed with the of the US National Institute of Health (NIH) Toolbox which comprises of standardised neurocognitive assessments. Global cognition will be assessed through a combination of assessments targeting the sub-domains of processing speed, episodic memory, executive function, working memory and attention. The tasks within the cognitive battery include the: Picture vocabulary, dimensional change card sort, flaker inhibitory control, auditory verbal learning and pattern comparison.
Timepoint [5] 437636 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [6] 437637 0
Wellbeing – World Health Organisation - 5 Well-Being Index (WHO-5)
Wellbeing: WHO-5. The WHO-5 is a short self-reported measure of current mental wellbeing. The WHO-5 consists of five statements, which respondents rate according to a 5-point scale ranging from "at no time" to "all the time".
Timepoint [6] 437637 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [7] 437638 0
Depression – Patient Health Questionnaire - 9 (PHQ - 9)
Depression: PHQ-9. The PHQ-9 is the depression sub-scale of the Patient Health Questionnaire. It scores each of 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day) and is used to screen for depression and measure the severity of depression symptomatology. The PHQ-9 is closely aligned with diagnostic criteria for major depressive disorder with scores of 10 or more indicating clinically significant symptoms (10–14, moderate; = 15, severe symptoms), and scores of 5–9 mild symptoms.
Timepoint [7] 437638 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [8] 437639 0
Anxiety – Generalised Anxiety Disorder - 7 (GAD-7)
Anxiety: GAD-7. The GAD-7 is a 7-item scale used to screen for generalised anxiety disorder and to measure the severity of anxiety symptomatology. The GAD-7 is closely aligned with diagnostic criteria for generalised anxiety disorder with scores of 10 or more indicating clinically significant symptoms (10–14, moderate; = 15, severe symptoms), and scores of 5–9 mild symptoms.
Timepoint [8] 437639 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [9] 437640 0
Sleep Quality – PSQI
A composite score of sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI). The PSQI a short comprehensive self-reported tool (5-10 minutes) to assess sleep quality. PSQI obtains multiple aspects of sleep including bedtime, time to fall asleep, getting up time, sleep duration per night, frequency of trouble falling asleep, trouble sleeping, self-rating of sleep quality, sleep medicine usage, trouble staying awake during the day, daytime activity enthusiasm, bed partner/roommate, secondary evaluation of snoring, sleep apnoea, twitching or jerking, episodes of disorientation or confusion during sleep, restlessness.
Timepoint [9] 437640 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [10] 437641 0
Sleep Disturbances - SCI
A composite score of sleep disturbances will be measured with the Sleep Condition Indicator (SCI): The SCI a short self-reported questionnaire that addresses both daytime and night-time factors of sleep disturbances/insomnia. SCI collects multiple measures including concerns about getting to sleep, remaining asleep, sleep quality, daytime personal functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep
Timepoint [10] 437641 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [11] 437642 0
Objectively measured sleep - Actigraphy - sleep duration
Actigraph: Objective measures of sleep duration will be collected through use of triaxial ActiGraph wGT3X-BT device. Participants will be instructed to wear the wrist device on non-dominant hand at all times for 24 hours/day for seven consecutive days. Valid day read will be accessed as valid data collection of sleep measurements for 22-24hours/day. A valid week read will be a minimum of 4 days of valid day read. Non-wear time will be defined as 0cpm for 90 minutes with an allowance of 2 minutes of activity when placed between tow 30 minutes windows of 0 cpm.
Timepoint [11] 437642 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [12] 437643 0
Self-reported physical activity – International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Self-reported physical activity: IPAQ-SF. The IPAQ-SF is a 9-item short form designed to assess a 7-day recall of physical activity behaviour separated into vigorous intensity (e.g. weight training), moderate intensity (e.g. leisure cycling), walking and sitting.
Timepoint [12] 437643 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [13] 437644 0
Blood pressure – Automated Sphygmomanometer
An automated sphygmomanometer will be utilised to record resting blood pressure in a supine position following 10 minutes of rest.
Timepoint [13] 437644 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [14] 437645 0
Grip Strength – Hand Grip Dynamometer
A hand group dynamometer will be utilised to measure maximal absolute grip strength in Kg. Participants will be required to stand with the measured arm at 90 degrees holding the dynamometer. Participants will then be asked to provide 3 maximal efforts for each arm and an average of each arm will be recorded.
Timepoint [14] 437645 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [15] 437646 0
Pulsewave velocity – Sphygmacor
Pulsewave velocity is a measure of arterial stiffness that is a predictor of cardiovascular risk. Pulsewave velocity will be assessed noninvasively using a finger clip probe.
Timepoint [15] 437646 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [16] 437647 0
Cardiorespiratory fitness
Cardiorespiratory fitness will be assessed through a sub-maximal volume of oxygen test. We will utilise the Astrand-Rhyming protocol, a validated protocol to assess the physical capacity of participants, estimate VO2 max and determine intensity for the intervention sessions.
Timepoint [16] 437647 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [17] 437648 0
Heart rate
Heart rate will be assessed using Polar H10 heart rate monitors. These monitors will be used to assist participants in maintaining the correct exertion throughout the intervention. The monitors will be connected to our training software that will indicate to participants when they are in the correct training zone to ensure adequate effort throughout the intervention.
Timepoint [17] 437648 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [18] 437649 0
Hand dexterity – Purdue pegboard
The Purdue pegboard will be utilised to measure hand dexterity. The Purdue pegboard test has been identified as a reliable measure of hand function with normative data available for healthy adults.
Timepoint [18] 437649 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [19] 437650 0
Dietary Intake
The Cancer Council Victoria diet questionnaire (DQES) will be completed and scored online. The DQES is a food frequency questionnaire that covers 80 items in 5 types of dietary intakes. It provides estimates of intake of major dietary categories. It has been validated in an Australian population of individuals in their 60s.
Timepoint [19] 437650 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [20] 437651 0
Acceptability to a physical activity intervention
Acceptability Questionnaire: Developing an understanding of participants acceptability to physical activity Interventions can benefit the development of future studies and Interventions. Whilst there Is some use to validated acceptability questionnaires, significant modifications are required to match the specific circumstances of the proposed study. An approach guided by a hybrid of the parsimony of the Single-Item Narcissism Scale and the social psychology approach to ask about 'someone like you' rather than the Individual themselves to mitigate confounders associated with Individual's characteristics. A pre-intervention quantitative approach will be developed with both quantitative and qualitative methods for the post Intervention questionnaire. A 5-point scale will be adopted for all quantitative questions. Examples of proposed quantitative questions Include: 'How useful do you think an exercise intervention might be for friends your age?’ And ‘Do you think friends your age would be interested in a cognitively based intervention?’ Qualitative questions will be phrased similar to the following: ‘Do you feel participating in this study has changed your opinion about the [usefulness/likelihood of recommending] [exercise/cog/exercise + cog]?'
Timepoint [20] 437651 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [21] 437652 0
Perceived workload
The NASA-task load Index Is a multi-dimensional scale to assess participants self-perceived workload estimates from one or multiple tasks Immediately following task completion. The scale Is measured on a quantitative scale between 0-21, assessing mental, physical, and temporal demand, as well as perceived performance, effort and frustration.
Timepoint [21] 437652 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
Secondary outcome [22] 438534 0
Objectively measured sleep - Actigraphy - sleep efficiency
Actigraph: Objective measures of sleep efficiency will be collected through use of triaxial ActiGraph wGT3X-BT device. Participants will be instructed to wear the wrist device on non-dominant hand at all times for 24 hours/day for seven consecutive days. Valid day read will be accessed as valid data collection of sleep measurements for 22-24hours/day. A valid week read will be a minimum of 4 days of valid day read. Non-wear time will be defined as 0cpm for 90 minutes with an allowance of 2 minutes of activity when placed between tow 30 minutes windows of 0 cpm.
Timepoint [22] 438534 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [23] 438535 0
Objectively measured sleep - Actigraphy - wake after sleep onset
Actigraph: Objective measures of sleep onset will be collected through use of triaxial ActiGraph wGT3X-BT device. Participants will be instructed to wear the wrist device on non-dominant hand at all times for 24 hours/day for seven consecutive days. Valid day read will be accessed as valid data collection of sleep measurements for 22-24hours/day. A valid week read will be a minimum of 4 days of valid day read. Non-wear time will be defined as 0cpm for 90 minutes with an allowance of 2 minutes of activity when placed between tow 30 minutes windows of 0 cpm.
Timepoint [23] 438535 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline
Secondary outcome [24] 438536 0
Objectively measured sleep - Actigraphy - sleep fragmentation
Actigraph: Objective measures of sleep fragmentation will be collected through use of triaxial ActiGraph wGT3X-BT device. Participants will be instructed to wear the wrist device on non-dominant hand at all times for 24 hours/day for seven consecutive days. Valid day read will be accessed as valid data collection of sleep measurements for 22-24hours/day. A valid week read will be a minimum of 4 days of valid day read. Non-wear time will be defined as 0cpm for 90 minutes with an allowance of 2 minutes of activity when placed between tow 30 minutes windows of 0 cpm.
Timepoint [24] 438536 0
Pre-intervention (week 0 - baseline)
Post-intervention (week 13 - post-baseline)
3-months post baseline

Eligibility
Key inclusion criteria
- Generally healthy sedentary to recreationally active older adults living in the community aged 60-75 years
- Sufficient English proficiency to participate in all aspects of the study
- Adequate corrected visual and auditory acuity necessary to undertake the assessment and intervention tasks
- Current and valid drivers license
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Major neurological conditions (dementia, Parkinson's, MS, stroke, etc.)
- Major psychiatric conditions (major depressive disorder, schizophrenia, PTSD, etc.)
- Physical impairments that preclude participation in the physical activity conditions
- Major chronic conditions that may put participants at risk (e.g. angina, COPD, arrhythmias, etc.)
- Significant visual or auditory impairment that preclude participation in the cognitive tasks or communication with the research team

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple blocked randomisation was completed with 'sealedenvolope.com.' A random seed was generated and participants were stratified for sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analyses will be implemented with an intention-to-treat protocol.

The efficacy of the intervention (Primary aim) will be analysed within a multi-level modelling (MLM) framework. MLM report maximum likelihood estimates and standard error which are adjusted for potential intra-class clustering where repeated observations within the same individuals are likely correlated over time. As primary and secondary outcomes reflect variables with a combination of different distributions (e.g. Gaussian (normal), Binomial, Poisson), Linear, Logistic and Poisson regressions can be easily implemented within the MLM framework.

As the intervention is a level 2 factor (between person effect) the power of the analyses are drawn from the level 2 N, the number of individual recruited into the study (see Power Analysis section for information on planned sample size estimate).

A benefit of the MLM approach is that missing data (either from missing a wave or non-response on a single item at that wave) can be implemented with the Full information Maximum Likelihood (FIML) estimation method. Complete data is not required. Sensitivity analyses will consider the potential impact of missing data by comparing results from models of cases with complete information and FIML models with all cases. Possible imputation methods will be considered if necessary (E.g. multiple imputation using chained equations).

Other analyses are proposed to answer secondary Research Questions (aims 2-6). Appropriate analyses will be implemented to address each question. For example, Cross-sectional analyses (e.g. baseline analyses of the sample on secondary outcomes) will be analysed within a generalized linear modelling (GLM) framework. As with MLM, GLM easily implement Linear, Logistic and Poisson regressions. Further exploratory analyses may be considered. Latent Class Analyses may examine combinations of risk factors which may moderate intervention efficacy. Mixture Growth analyses may examine whether particular risk/protective factors drive different trajectories in outcomes over time.

For all analysis, results will balance the probability P of effects reported with the substantive size of effect. And owing to the clinical nature of the study, even small effects will be considered by the potential clinical utility of the findings (e.g. small effects may produce substantive clinical changes).

We will also investigate the possible mediating effects of the intervention on outcome measures through mechanisms or other known mediating factors such as sleep, mental health and cardiovascular risks.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/05/2023
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
90
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 311852 0
Commercial sector/Industry
Name [1] 311852 0
NRMA Driving Research Endowment Fund
Country [1] 311852 0
Australia
Primary sponsor type
University
Name
National Centre for Epidemiology and Population Health, Australian National University
Address
62 Mills Rd, Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 315681 0
None
Name [1] 315681 0
Address [1] 315681 0
Country [1] 315681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311292 0
University of Canberra Research Committee
Ethics committee address [1] 311292 0
Ethics committee country [1] 311292 0
Australia
Date submitted for ethics approval [1] 311292 0
08/08/2022
Approval date [1] 311292 0
07/11/2022
Ethics approval number [1] 311292 0
11846

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

Contacts
Principal investigator
Name 120598 0
Prof Nicolas Cherbuin
Address 120598 0
National Centre for Epidemiology and Population Health, Australian National University, 62 Mills Rd, Acton ACT 2601
Country 120598 0
Australia
Phone 120598 0
+61 2 6215 3858
Fax 120598 0
Email 120598 0
nicolas.cherbuin@anu.edu.au
Contact person for public queries
Name 120599 0
Nicolas Cherbuin
Address 120599 0
National Centre for Epidemiology and Population Health, Australian National University, 62 Mills Rd, Acton ACT 2601
Country 120599 0
Australia
Phone 120599 0
+61 2 6215 3858
Fax 120599 0
Email 120599 0
nicolas.cherbuin@anu.edu.au
Contact person for scientific queries
Name 120600 0
Nicolas Cherbuin
Address 120600 0
National Centre for Epidemiology and Population Health, Australian National University, 62 Mills Rd, Acton ACT 2601
Country 120600 0
Australia
Phone 120600 0
+61 2 6215 3858
Fax 120600 0
Email 120600 0
nicolas.cherbuin@anu.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?
Published data.
When will data be available (start and end dates)?
At the end of the trial
All data will be available for 15 years after publication
Available to whom?
Reviewers and other researchers who wish to check analyses. As part of collaborative projects to any approved collaborator, and potentially others provided requests are made in writing and approved by the PhABHeaD research committee.
Available for what types of analyses?
Replications and subject to the above, empirical studies, meta-analyses and mega-analyses
How or where can data be obtained?
By contacting the chief investigator via their email address - nicolas.cherbuin@anu.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19117Study protocol    From publisher once accepted for publication
19118Informed consent form  nicolas.cherbuin@anu.edu.au By contacting the chief investigator via email Pr... [More Details]
19119Ethical approval  nicolas.cherbuin@anu.edu.au By contacting the chief investigator via email Pr... [More Details]
19120Analytic code    In supplementary material of published papers



Results publications and other study-related documents

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