Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000983606
Ethics application status
Approved
Date submitted
11/08/2023
Date registered
8/09/2023
Date last updated
11/04/2024
Date data sharing statement initially provided
8/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Changing the focus: Facilitating engagement in physical activity for people living with mild dementia in a local community - A feasibility study
Scientific title
Changing the focus: Facilitating engagement in physical activity for people living with mild dementia in a local community - A pre and post mixed methods feasibility study
Secondary ID [1] 310286 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 330980 0
Condition category
Condition code
Public Health 327800 327800 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preparation:
In preparation for the intervention, the project team will develop a training program for exercise practitioners in the Frankston / Mornington Peninsula area, Victoria, Australia who are interested in improving their understanding of strategies to support working with people with mild dementia in programs they provide. Training will include in-person opportunities at the start of the intervention period, and online resources will be made available for exercise practitioners who engage with the program. Another round of in-person training opportunities can be arranged mid study depending on the interest of new exercise practitioners who join the program.
We encourage exercise practitioners to attend the training program, however, this training is optional (not compulsory for the intervention). This is because in usual practice, exercise practitioners do not have to attend training to do their daily work. If they choose to do the training, they can decide to attend in person or online or do both.
The in-person training workshop can cater for up to 30 practitioners per workshop and will be facilitated by two project team members.
The in-person training will be conducted at the commencement of project recruitment and a repeated session may occur approximately 6-9 months after project commencement, depending on the interest from new physical activity providers who engage with the program over time.
The in-person training workshop will be a once off session, approximately 2-3 hours in duration with a 15 minutes rest break during the workshop. The online training is expected to take approximately 2-3 hours to complete, consisting of all learning modules and further e-resources, open to those interested throughout the study period.

An updated Peninsula Health physical activity program directory in the local areas will be promoted through the training program, and be made available to the research staff supporting the decision making about suitable physical activity options in the local area for each participant with dementia, as well as to referrers and providers who request a copy.

The shared decision support tool is being developed based on results from a series of three stakeholder co-design panels and interviews incorporating key stakeholders (including people with dementia and their carers, exercise providers, health services managers, and peak organisation representatives) that had the broad aim of informing approaches to optimise uptake and sustained participation in increased physical activity for people with mild dementia. The shared decision support tool notes assessment items (relating to physical performance measures) and questions that may influence physical activity decisions (including previous and current physical activities, health problems impacting physical activity, transport factors, and costs). It will be an A4 page with prompt questions and progresses the users (the health professional, the person with dementia and their carer) through to the stage of identifying one or more preferred physical activity options to follow up with in the local area. Physical activity options will include structured programs such as gym, group exercise or home programs; informal physical activity programs such as a walking program (individual or as a group), and recreational activities that have a physical activity component (eg lawn bowls, golf, dance).

First home visit (~2.5 hours). Following recruitment and screening for eligibility criteria, an initial home visit will be organised by the study therapist (a Physiotherapist or Exercise Physiologist) at the home of the person with dementia and their carer. This first home visit will include (1) a consenting process (see details in the section of Ethics and ethical issues-consent and withdrawal) for the person with dementia +/- carers if applicable, (2) assessment of baseline physical performance outcomes; (3) identification of domains of physical performance (based on assessment outcomes) outside of age adjusted normal limits as potential intervention priorities, (4) discussion of physical activities that are likely to address impairments, (5) discussion about physical activities they enjoy, or have previously undertaken, and (6) discussion of physical activity options available locally.
A shared-decision support tool (see above) will be used by the study therapist and the person with dementia (and their carer if they have one) to aid the decision making discussion used by the study therapist and the person with dementia and their carer in this home visit. This discussion will also incorporate the setting of physical activity goals.
Whatever physical activity options are selected, each individual’s program will aim to: (1) address identified physical impairments; (2) incorporate multimodal (balance, strength and fitness) physical activities personalised to the person, across the week; and (3) progress dosage of physical activity intervention by 10-20% / month from the baseline physical activity level, starting from month 1 (e.g. if doing 30 min/week, initial target=36 min/week) and aiming to progress at each month to reach a minimum 12-month target of greater than or equal to 150 min/week. Progression principles for increasing dosage will be provided to participants/carers and discussed during motivational support calls during the 12 months intervention period.
The total time of physical activity participation undertaken each week for new and/or changed physical activities as a result from participation in the study (frequency and duration) will be recorded in a physical activity diary on a weekly basis by the person with mild dementia or their carer.
To assist with the discussion of physical activity options available locally, the Peninsula Health physical activity program directory will be utilised, as well as other programs the research team identify. Examples of local physical activity programs that may be discussed include group exercise (e.g. community health centre), Council on The Ageing strength training programs, gym programs, and walking programs. Individually tailored home exercise programs (provided by the study therapist) will also be offered as another option (it is anticipated this option may be selected by approximately 40%), augmented by telehealth options.

Second home visit (~45 mins). The study therapist will perform a second home visit for the person with dementia and/or their carer at week 3 of the decision-making session (when the physical activity plan has commenced) to provide motivational support.

Third home visit (~1 hour). The study therapist will perform a third home visit for the person with dementia and/or their carer at six months to repeat physical performance outcomes, and discuss participation level, participation barriers and facilitators, and sustained participation in physical activities longer term.

Fourth home visit (~1 hour). The study therapist will perform a fourth (and final) home visit for the person with dementia and/or their carer at 12 months to repeat physical performance outcomes, and discuss participation level, participation barriers and facilitators, and maintenance of physical activity longer term.

Motivational support (~20 minutes for each phone/video call). After the first home visit, motivational support will be provided by the study therapist through a series of telephone contacts. Seven phone calls (or video-conference) will occur in the months 0-6 of each individual’s intervention (suggested phone schedule at week 2, 6, 9, 12, 16, 20 and 24). Guided by the COM-B framework for behaviour change, the aim is to increase capability (defined as the individual's psychological and physical capacity to engage in the physical activity program by having the necessary knowledge and skills), provide motivation (defined as processes that energize and direct behaviour including goals and decision-making) and capitalise on the opportunity (defined as all the factors that lie outside the individual that make physical activity participation possible) to reinforce exercise behaviour.
Each call will focus on discussing the program, challenges, barriers, facilitators, revisiting the goal and troubleshooting for solutions. If indicated, (e.g. health status change) additional home visits or phone calls may be scheduled.
Intervention code [1] 326668 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335644 0
Program participation:
The proportion of people with dementia continuing with the program at 12 months (using >70% continuing with their selected programs) at 12 months as a benchmark for success
Timepoint [1] 335644 0
At 12 month (i.e. at the completion of the program).
This is assessed by participant's (or the carer) self-report, and verified by the study therapist's interview with participants at each contact (home visit and telephone support) and entry in the participant's physical activity diary.
Primary outcome [2] 335645 0
Program acceptability:
This will be explored through a semi-structured interview with all participant groups (participants living with mild dementia and their carers, referrers and physical activity providers):
a) Participants with dementia and their carers will be interviewed at month 6 or at the time of program withdrawal, using a purposive sample aiming for diversity of physical activity program and participation levels. The interview will explore their perspectives on acceptability of the program, the shared decision-making process, support for participation, perceived benefits of participation, and barriers/facilitators to participation and the future sustainability of the “Changing the focus” program.
b) Referrers will be interviewed at 1-2 months following providing one or more referrals, using a purposive sample covering for a diverse mix of health professionals such as general practitioners, physiotherapists, and exercise physiologists. The interview will explore how the referrer heard about the program, program acceptability from their perspective, the type of benefits they consider the person with dementia may obtain from increasing their physical activity, factors they consider are important in determining if a person with dementia might be suitable for participation in this type of program, how they may be able to support uptake and sustained participation in the program by the person living with dementia, and future sustainability of the “Changing the Focus” program.
c) Physical activity/exercise providers will be interviewed at month 6, using a purposive sample for providers aiming for diversity of physical activity/exercise programs, and including those who have and have not participated in the optional training (described below) to support them working effectively with people living with dementia. The interview will explore physical activity providers’ satisfaction with the in-person training and/or online training resources if they undertook the optional training (training resources developed by the research team); suggested improvements that can be made to the training resources and any other training that they felt is required; their confidence with working with people living with dementia, and whether adjustments were required to accommodate the person living with dementia into the program; program acceptability from their perspective, perspectives about what worked well, what may have been able to be done differently to achieve better outcomes; changes noted associated with physical activity participation for the person with dementia involved in their program; and whether the exercise provider would be seeking opportunities to attract more people living with dementia to this type of physical activity program, and the future sustainability of the “Changing the Focus” program.
In addition, participants with mild dementia and their carers will answer a question at 6 and 12-month assessments “Is the “Changing the Focus” program acceptable (i.e. suitable for you and adequate to meet your needs)? They can select a response of “Yes”, “No” or “Unsure”. The study will use a target criterion of >75% as a benchmark to determine program acceptability.
Timepoint [2] 335645 0
Interviews timepoints:
People with mild dementia and their carers-At month 6 or time of withdrawal from the study.
Referrers-At month 1-2 following prooviding referrals.
Physical activity/exercise providers-At month 6 of participants with mild dementia attending their program.
For the question for participants with mild dementia and their carers "Is the Changing the Focus program acceptable"?-At month 6 and 12
Primary outcome [3] 335861 0
Total physical activity time per week for the preceding week:
For the preceding week or if the preceding week was atypical – e.g. the person was unwell and did not do physical activities, then the most recent typical week in the preceding month will be documented. This will be measured by the Active Australia Survey conducted at baseline, month 6 and month 12.
Timepoint [3] 335861 0
At baseline (month 0), month 6 and month 12 assessments
Secondary outcome [1] 425043 0
Life space using the Life Space Assessment-Cognitive Impairment questionnaire
Timepoint [1] 425043 0
At baseline (month 0), 6 and 12 months
Secondary outcome [2] 425062 0
Dynamic balance using Step test
Timepoint [2] 425062 0
At baseline (month 0), 6 and 12 months
Secondary outcome [3] 425063 0
Endurance using 2 minute walk test
Timepoint [3] 425063 0
At baseline (month 0), 6 and 12 months
Secondary outcome [4] 425064 0
Leg strength using 30 second sit-to-stand test
Timepoint [4] 425064 0
At baseline (month 0), 6 and 12 months
Secondary outcome [5] 425066 0
Mobility using Timed Up and Go test
Timepoint [5] 425066 0
At baseline (month 0), 6 and 12 months
Secondary outcome [6] 425068 0
Cognition using the Mini Mental State Examination
Timepoint [6] 425068 0
At baseline (month 0), 6 and 12 months
Secondary outcome [7] 425069 0
Social connectedness using Lubben Social Network Scale-6
Timepoint [7] 425069 0
At baseline (month 0), 6 and 12 months
Secondary outcome [8] 425070 0
Physical activity enjoyment using the Physical Enjoyment Scale PACES-8
Timepoint [8] 425070 0
At baseline (month 0), 6 and 12 months
Secondary outcome [9] 425071 0
Activity of Daily living using the KATZ Activities of Daily Living Index
Timepoint [9] 425071 0
At baseline (month 0), 6 and 12 months
Secondary outcome [10] 425072 0
Quality of Life using the health-related QoL scale EQ5D5L for person with dementia
Timepoint [10] 425072 0
At baseline (month 0), 6 and 12 months
Secondary outcome [11] 425073 0
The impact of caring using the Zarit Carer Burden Scale (for carers only)
Timepoint [11] 425073 0
At baseline (month 0), 6 and 12 months
Secondary outcome [12] 425075 0
Occurrence of any adverse events including falls and injuries. a) Number of falls in each month, b) circumstances and activity during falls, and c) injury as a result of the fall, recorded by the person with mild dementia or carer using a daily falls diary. A fall will be defined as “inadvertently coming to rest on the ground, floor or other lower level, excluding intentional change in position to rest in furniture, wall or other objects”.
Timepoint [12] 425075 0
Any time within the 12 month program
Secondary outcome [13] 425077 0
Additional physical activity data using a weekly physical activity diary. Only new and/or changed physical activities undertaken as a result of participation in the study will be recorded weekly by the person with mild dementia and/or their carer. The total time spent in these new and/or changed physical activities each week will be added. The physical activity diary will be collected by the study therapist at each phone call and home visit.
Timepoint [13] 425077 0
Weekly duing the 12 month program
Secondary outcome [14] 425078 0
Health care cost data (through customised participant surveys-self-reported, quality adjusted life years)
Timepoint [14] 425078 0
At baseline (month 0), 6 and 12 months
Secondary outcome [15] 425919 0
Quality of Life using the health-related QoL scale EQ5D5L for carer of person with dementia
Timepoint [15] 425919 0
At baseline (month 0), 6 and 12 months
Secondary outcome [16] 425920 0
Program cost data (through customised survey-reported by project manger)
Timepoint [16] 425920 0
Monthly to month 12

Eligibility
Key inclusion criteria
For people with mild dementia or cognitive impairment:
Adults (age greater or equal to 60 years); living in the community; medical diagnosis of dementia–mild severity (MMSE greater or equal to 18) or people without a medical diagnosis of dementia and with a MMSE score of 18-23 inclusive, at recruitment; not housebound due to physical impairments (e.g. severe stroke); not meeting World Health Organisation physical activity guidelines for older people (<150 minutes moderate/vigorous physical activity/week); and have capacity to consent and willingness to assist in data collection. For a person with dementia who is unable to provide consent, they can participate in the study if they have an informal carer responsible who will be able to provide consent on their behalf.
Presence of an informal carer is preferred but not essential. Where available, they will be an important support for the person with dementia during the intervention. Recruitment will include people from culturally and linguistically diverse backgrounds who have sufficient English proficiency to understand the study, assessment / intervention instructions, or have a readily available interpreter (family member/friend able to assist).
Note that a purposive sub-sample of the participants with dementia will be recruited to undertake semi-structured interviews at 6 months, with a separate consent process for this component.

For informal carer:
Adults (age greater or equal to 18 years); willingness to assist in data collection; capable to assist the person with dementia to adhere to the chosen physical activity program and/or home exercises if required.
Note that a purposive sub-sample of informal carers will be recruited to undertake semi-structured interviews at 6 months, with a separate consent process for this component.

For referrers and exercise leaders providing physical activity options for participants with dementia:
Health professionals (e.g. general practitioners, Cognitive Dementia and Memory Service staff, community therapists) who refer people with dementia to the “Changing the Focus” program, and exercise practitioners who implement physical activity programs with participants will be involved in semi-structured interviews to obtain their perspectives of the program.
Note that a purposive sub-sample of referrers and exercise leaders will be selected to participate in semi-structured interviews.

The following answers (minimum and maximum age, sex and healthy volunteers) refer to the Key participant group "People with mild dementia/cognitive impairment"
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For people with mild dementia/cognitive impairment:
Not living in the community of Frankston/Mornington Peninsula region, MMSE cognitive score if without a dementia diagnosis is less than 18 or higher than 23 or MMSE cognitive score of less than 18 for those with a dementia diagnosis, those already meeting 150 minutes of physical activity per week, those who are housebound.

For informal carers of people with mild dementia/cognitive impairment:
Aged less than 18 years.

For referrers:
Those who are not health professionals or not working in Frankston/Mornington Peninsula and those who have not referred one or more of their clients to the "Changing the Focus" program

For exercise providers:
Those who are not working in Frankston/Mornington Peninsula and those who do not provide a physical activity program to one or more of the people with mild dementia participating in the "Changing the Focus" program

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)
No randomisation or control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A pre and post mixed methods feasibility study design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size consideration:
A formal sample size calculation is not relevant for this feasibility study. However, we have considered our sample size based on the main primary outcome of program participation (benchmark criterion for success >70% of participants with mild dementia continuing with “Changing the Focus” at 12-months). Using a sample size of 60 people living with mild dementia, we will be able to estimate a participation rate of 71% to within a 95% confidence interval of +/- 11.5%.
The sample size for the interviews of people living with dementia and their carers, referrers and physical activity providers (estimated to be 15-20 per group), will each be to the point of adequate information power.

Data analysis:
Descriptive analyses will be used to report demographic characteristics and the primary outcomes of participation and program acceptability based on the >70% and >75% benchmark criterion of success respectively as well as other outcomes regarding implementation aspects (i.e. reach, maintenance, safety and additional physical activity time data). Adverse events including falls and injuries will be summarised using descriptive statistics and narratives.
Interview data regarding program acceptability and other implementation outcomes from all participant groups will be recorded and transcribed verbatim, with two researchers independently reviewing and coding data to generate themes and sub-themes using thematic analysis.
For the primary outcome of total physical activity time per week in the last week and secondary outcomes, a general linear mixed model using fixed effects for the set time points, random effects for the participants will be used to analyse the change in outcomes over time. In case of missing data for the physical performance tests due to “inability to perform” e.g. physical limitations of the participants, we will assign a value (indicating the worst possible score) to the missing data for this reason and use ordered logistic regression instead. The assigned value would be different for these tests. For the dynamic balance step test, 2-minute walk test and the 30-second sit-to-stand test, the assigned number will be zero, while the Timed-up-and-Go-test would be 999 (assuming no participant who actually completes the test has a higher value than this).

Analysis of economic efficiency
The costing of items in the economic evaluation will be based on actual costs where available, and where these are not available, costs, excluding carer time, will be based on market rates, with carer time based on the current Australian minimum wage. All costs will be presented as AUD 2024/25, with costs collected prior to 2024/25 to be inflated by the consumer price index (https://www.rba.gov.au/calculator/).
The cost of program implementation analysis will report each cost type (including costs attributed to implementing and running the physical activity and dementia referral pathway, training of physical activity personnel, and participant costs for program access), including the number of units utilised, the cost per unit, and the total cost. Results will be presented as an overall cost, as well as a cost per participant to inform the cost-effectiveness and cost-utility analyses.
Cost data will be collected for the person living with dementia and this will be analysed for each time point using an independent t-test with the mean (SD) reported, as well as the mean difference (95%CI) between time points.
Effect data includes falls (only for the person living with dementia) and quality of life (both the person living with dementia and their care-partner). EQ-5D-5L raw scores will be converted into a utility index, and the change in utility index from one time point to the next will be used to calculate the quality adjusted life years (QALY) gained or lost. Effect data will be analysed for each time point using an independent t-test with the mean (SD) reported, as well as the mean difference (95%CI) between time points.
Cost and effect data will be combined for the cost-effectiveness analysis (costs and falls data only for the person living with dementia) and for the cost-utility analysis (costs and quality of life data for both the person living with dementia and their carer). The incremental cost effectiveness ratio (ICER) will be calculated using the bootstrap method (5,000 replications) with the results presented on a cost-effectiveness plane and as a probability of cost-effectiveness across a range of willingness to pay thresholds (AUD $0 to $50,000).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
28/03/2025
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25322 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 41026 0
3199 - Frankston
Recruitment postcode(s) [2] 41078 0
3912 - Pearcedale
Recruitment postcode(s) [3] 41077 0
3912 - Somerville
Recruitment postcode(s) [4] 41067 0
3915 - Hastings
Recruitment postcode(s) [5] 41075 0
3916 - Merricks
Recruitment postcode(s) [6] 41074 0
3916 - Point Leo
Recruitment postcode(s) [7] 41076 0
3916 - Shoreham
Recruitment postcode(s) [8] 41081 0
3927 - Somers
Recruitment postcode(s) [9] 41071 0
3930 - Mount Eliza
Recruitment postcode(s) [10] 41068 0
3936 - Arthurs Seat
Recruitment postcode(s) [11] 41069 0
3936 - Dromana
Recruitment postcode(s) [12] 41070 0
3936 - Safety Beach
Recruitment postcode(s) [13] 41072 0
3937 - Red Hill
Recruitment postcode(s) [14] 41073 0
3937 - Red Hill South
Recruitment postcode(s) [15] 41064 0
3939 - Rosebud
Recruitment postcode(s) [16] 41065 0
3941 - Rye
Recruitment postcode(s) [17] 41079 0
3941 - St Andrews Beach
Recruitment postcode(s) [18] 41080 0
3941 - Tootgarook
Recruitment postcode(s) [19] 41066 0
3943 - Sorrento

Funding & Sponsors
Funding source category [1] 314498 0
Government body
Name [1] 314498 0
Commonwealth Government of Australia through the Community Health and Hospitals Program Grant Scheme; National Health and Medical Research Investigator Grant,
Country [1] 314498 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Moorooduc Hwy, Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 316441 0
None
Name [1] 316441 0
Address [1] 316441 0
Country [1] 316441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313543 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313543 0
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 313543 0
Australia
Date submitted for ethics approval [1] 313543 0
11/08/2023
Approval date [1] 313543 0
14/09/2023
Ethics approval number [1] 313543 0
39672
Ethics committee name [2] 313546 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [2] 313546 0
2 Hastings Rd Ngarnga Centre, Frankston Hospital, Frankston VIC 3199
Ethics committee country [2] 313546 0
Australia
Date submitted for ethics approval [2] 313546 0
01/09/2023
Approval date [2] 313546 0
04/12/2023
Ethics approval number [2] 313546 0
HREC/102657/PH-2023 and SSA/102657/PH-2023 

Summary
Brief summary
"Changing the Focus" program addresses two significant health problems of older Australians:
(a) Dementia. The incidence and prevalence of dementia in Australia is projected to grow from 459,000 in 2020, to 1,076,000 by 2058. While the major direct impacts of dementia are cognitive impairment and progressive cognitive decline, onset and progression of dementia are also associated with other health problems that have significant negative personal and carer impact, and add resource and economic cost to health and care systems. Impacts to the individual include reduced independence, physical function, balance, mobility, and community participation, poor mental health, and increased falls.
(b) Low levels of physical activity. Older people generally have low physical activity levels, with only 25% of Australians aged >65 years meeting physical activity guidelines. People with dementia have even lower activity levels. Further, physical activity reduction post dementia diagnosis is associated with accelerated cognitive decline. For older people, higher physical activity levels reduce the risk of chronic disease and falls, and improve balance, mobility, function, psychological health, wellbeing and quality of life. Systematic review evidence supports that various forms of physical activity can be implemented safely, and achieve similar outcomes for people with dementia and improve or delay decline in cognition and structural brain changes. Other benefits include improved activities of daily living and reduced social isolation.
No systematic approach exists for identifying physical activity needs, or promoting physical activity in people with dementia, despite growing evidence of physical activity benefits along the dementia pathway. This research addresses this major unmet need for an early, systematic approach to identify physical activity needs for people with mild dementia, and embed referral pathways/training opportunities for exercise leaders to support improved physical activity options.
Effective management of physical inactivity is required to improve outcomes for the person with dementia and their carer before later stages of dementia, when problems become greater and less amenable to intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128490 0
Prof Keith Hill
Address 128490 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University (Peninsula Campus), Moorooduc Highway, Frankston, Vic 3199
Country 128490 0
Australia
Phone 128490 0
+61 3 99024445
Fax 128490 0
Email 128490 0
keith.hill@monash.edu
Contact person for public queries
Name 128491 0
Dr Den-Ching Angel Lee
Address 128491 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University (Peninsula Campus), Moorooduc Highway, Frankston, Vic 3199
Country 128491 0
Australia
Phone 128491 0
+61 3 99044662
Fax 128491 0
Email 128491 0
angel.lee@monash.edu
Contact person for scientific queries
Name 128492 0
Prof Keith Hill
Address 128492 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University (Peninsula Campus), Moorooduc Highway, Frankston, Vic 3199
Country 128492 0
Australia
Phone 128492 0
+61 3 99024445
Fax 128492 0
Email 128492 0
Keith.hill@monash.edu

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?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19894Study protocol  angel.lee@monash.edu Research protocol: Changing the focus: Facilitati... [More Details] 386358-(Uploaded-06-02-2024-14-09-01)-Study-related document.docx
19895Informed consent form  angel.lee@monash.edu Consent forms for all participant groups 386358-(Uploaded-09-08-2023-15-56-38)-Study-related document.pdf
19896Other  angel.lee@monash.edu Combined Explanatory Statements for all participan... [More Details] 386358-(Uploaded-08-02-2024-11-01-58)-Study-related document.pdf
19968Other  angel.lee@monash.edu Data collection surveys at baseline, month 6 and 1... [More Details] 386358-(Uploaded-06-02-2024-14-03-23)-Study-related document.pdf
19969Other  angel.lee@monash.edu Combined interview schedules for all participant g... [More Details] 386358-(Uploaded-09-08-2023-16-08-44)-Study-related document.pdf
19970Other  angel.lee@monash.edu Falls and Physical activity diary 386358-(Uploaded-06-02-2024-14-06-24)-Study-related document.pdf
22165Ethical approval    386358-(Uploaded-12-12-2023-13-27-46)-Study-related document.pdf
22166Other    Explanatory statement for participants Data colle... [More Details] 386358-(Uploaded-06-02-2024-14-07-40)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19894Study protocol  angel.lee@monash.edu Research protocol: Changing the focus: Facilitati... [More Details] 386358-(Uploaded-06-02-2024-14-09-01)-Study-related document.docx
19895Informed consent form  angel.lee@monash.edu Consent forms for all participant groups 386358-(Uploaded-09-08-2023-15-56-38)-Study-related document.pdf
19896Other  angel.lee@monash.edu Combined Explanatory Statements for all participan... [More Details] 386358-(Uploaded-08-02-2024-11-01-58)-Study-related document.pdf
19968Other  angel.lee@monash.edu Data collection surveys at baseline, month 6 and 1... [More Details] 386358-(Uploaded-06-02-2024-14-03-23)-Study-related document.pdf
19969Other  angel.lee@monash.edu Combined interview schedules for all participant g... [More Details] 386358-(Uploaded-09-08-2023-16-08-44)-Study-related document.pdf
19970Other  angel.lee@monash.edu Falls and Physical activity diary 386358-(Uploaded-06-02-2024-14-06-24)-Study-related document.pdf
22165Ethical approval    386358-(Uploaded-12-12-2023-13-27-46)-Study-related document.pdf
22166Other    Explanatory statement for participants Data colle... [More Details] 386358-(Uploaded-06-02-2024-14-07-40)-Study-related document.pdf

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