ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001114134

Ethics application status

Approved

Date submitted

30/07/2019

Date registered

12/08/2019

Date last updated

27/05/2024

Date data sharing statement initially provided

12/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Falls After Stroke Trial (FAST)

Scientific title

Home-based, tailored intervention to reduce falls after stroke trial.

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1236-3468

Trial acronym

The FAST study

Linked study record

This record :ACTRN12615000753550 was the pilot study of the FAST trial.

Health condition

Health condition(s) or problem(s) studied:

Falls

Community participation

Self efficacy

Balance

Mobility

Physical Activity

Health related quality of life

Health care utilisation and costs

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The falls after stroke trial (FAST) will be undertaken in metropolitan Sydney and Canberra Australia.
The intervention will have an active 6 month intervention period and a passive (further) 6 months follow-up period.
Participants randomised into the intervention (experimental) group will receive a home-based, tailored intervention consisting of habit-forming exercise and home/community safety training depending on their level of disability. For example, the faster walkers (> 0.8 m/s) will have most emphasis on habit-forming exercise, the slower walkers (< 0.4 m/s) will have most emphasis on safety training, while the middle group (0.4-0.8 m/s) will have a combination of both habit-forming exercise and safety training. Habit-forming exercise will be based on the successful Lifestyle integrated Functional Exercise program which has been shown to be beneficial for older persons with a history of two or more falls or an injurious fall in a study by Professor Lindy Clemson and colleagues [Clemson, L., et al., Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. British Medical Journal, 2012: p. 345]. This program encourages participants to look for ways of doing more physical activity. Activities which challenge their balance and strength will be incorporated into specific daily tasks. They will be performed intentionally and consciously until they become habitual and embedded in daily occupation. Feedback and monitoring via paper documentation and positive reinforcement will be used to enhance the performance of these activities and the self-efficacy of the participants. Rather than a prescribed set of exercises conducted several times a week, activities will occur whenever the opportunity arises during the day. An activity incorporating the strategy of challenging balance by “reducing base of support” might involve a tandem stand while working at the kitchen bench, and over time could be progressed to working while standing on one leg. An activity incorporating the strategy of increasing strength by “bending the knees” might involve squatting instead of bending at the waist to close a drawer, and could be progressed to squatting to close a lower drawer.
The safety intervention will focus on environmental adaptations to reduce fall hazards and protective behaviours to reduce risk. The Westmead Home Safety Assessment and the Falls Behavioural Scale for Older People will be used to identify environmental hazards, as well as risks, so that the participants and therapist can generate solutions. A community mobility goal will be identified for each intervention participant that is relevant for them with a plan to practice related strategies . The intervention will incorporate strategies for enhancing self-efficacy, cueing and monitoring to booster adherence, and engagement of participant in planning, decision making and follow through. Participants will have access to a selection of simple home adaptations, such as non-slip strips, double sided tape to secure carpets, LED sensor globes to improve night lighting, in addition to referral to usual home modification services in the community. Participants under the guidance of therapists will be also encouraged to practice safe activities that are within their current capabilities in the home and community.
Materials, instruction booklets or any other equipment the participant may need to complete the intervention component will be provided to the participant at no cost.

The home-based tailored intervention will be delivered through 7 weekly home visits followed by three booster sessions at Weeks 9, 13, 19 with two phone calls during Week 15 and 23. The intervention dose is warranted, given stroke survivors are at greater risk of falls and we are providing a combined intervention of habit forming exercise and safety. Participants will record practice using weekly logs to monitor adherence to the exercise. It is expected that home visits will take approx. 1-1.5 hours while booster phone calls will last between 30min-1h.

The intervention and all assessments will be provided by experienced physiotherapists and occupational therapists. All study parts (assessment, intervention and follow-up) will take place in the comfort of the participant’s home at a mutually convenient time. Therapists have experience in working with older adults, adults with age-related disability and have previously worked in the community or out-patient setting. All assessors will undergo a 2 day training workshop, where they will learn the standardised assessments, data management and any other study related standardised operating procedures. All interventionists (occupational therapists and physiotherapists) will part-take in a 2 day workshop to learn the Life-style integrated physical activity programme as well as learning the home-safety and community mobility programme. Further, occupational therapists must, and physiotherapists are encouraged to complete the online learning module available for home-safety for this cohort. Therapists are required to complete the training successfully prior delivering the intervention. Throughout the intervention trial, various fidelity checks will occur for both assessors and interventionist to ensure standardised procedures.

Adherence to the trial will be measured in several ways. Participants are required to document their planned activities in their activity planner while also in reporting, in a pre-defined interval, which activities they have completed via their activity counter. Further, participants will complete the Exercise Adherence Rating Scale (EARS) during their last home visit in week 23 and again during the 12 month follow-up. This will provide us with an objective adherence measure alongside regular documentation.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control group will receive usual care which will equate to no active intervention. This reflects the current situation for community-dwelling individuals after stroke discharged from rehabilitation in Australia, where opportunities for rehabilitation largely cease by 6 months.
We expect that we will finish this study in 2023, and that at this time, we will mail a one-page summary of the findings to all interested participants which they can share with their local healthcare provider about how to deliver the new intervention. We will also share this information with the Stroke Foundation to post on the EnableMe website.

Control group

Active

Outcomes

Primary outcome [1]

Number and rate of falls will be measured (monthly) prospectively using falls calendars (to be returned using reply paid envelopes) or via an online survey. Information about fall circumstances and possible injuries will also be recorded. Participants who forget to report back monthly will be called by a member of the research team. Rate of falls will be our primary outcome measure.

Timepoint [1]

Monthly between 0-12 months post randomisation

Secondary outcome [1]

Proportion of fallers in each group
Proportion of fallers will be calculated used the monthly falls calendars, which participants are asked to fill in. If participants fail to return this information to the study team, a blinded assessor will contact the participants to obtain this information. Using monthly falls calendars to obtain falls data is considered the golden standard

Timepoint [1]

Determined at the end of 12 months by recording proportion of participants in each group that had 1 or more falls over the year

Secondary outcome [2]

Community participation;
the 'disability' component of the Late Life Function and Disability Index will be used to understand and quantify community participation.

Further, participation will be measured using two questions (Likert Scale)

Timepoint [2]

Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [3]

Self-efficacy measured using two questions based on the Falls efficacy scale –International. (Questions: Please choose the response most appropriate to you: 1) How concerned you are that you might fall when carrying out your usual activities at home? and 2) How concerned you are that you might fall when carrying out your usual activities when away from home?
Responses: Not at all concerned (1) Somewhat concerned (2) Fairly concerned (3) Very concerned (4)

Timepoint [3]

Measured from baseline, at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [4]

Balance measured using the balance component of the Short Physical Performance Battery and the Step test

Timepoint [4]

Measured from baseline, at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [5]

Mobility measured as preferred and fast gait speed over 5m and by 2 self-reported questions. The questions require participants using a 5 point likert scale to estimate maximum distance and duration of walking continuously.

Timepoint [5]

Measured from baseline, at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [6]

Physical activity measured as Total, Planned and Incidental hours/week using the Incidental and Planned Exercise Questionnaire. The 'function' component of the Late Life Function and Disability Index will be used to understand and quantify subjective physical activity and ability. In a sub study (n=50) physical activity will be assessed by and the ActivPAL, an accelerometer-based monitor to measure physical activity over 7 days

Timepoint [6]

Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [7]

Health related quality of life;
the EQ5D (5L) will be used to assess health related quality of life. Participants will also report their quality of life on a 100 point VAS.

Timepoint [7]

Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [8]

Health care utilisation and costs;
Retrospective information will be collected about health care utilisation during the previous 12 months before study enrolment and prospectively on calendar every 6 months during the study period.
Information about regular help with ADLs will also be collected using a simple count.

Timepoint [8]

Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [9]

Programme adherence will be reported using the Exercise Adherence Rating Scale(EARS)
The EARS score will also be used as the dependant variable to analyse the impact and moderating effect of adherence on treatment outcome, The per-protocol/CACE analysis is hypothesised to show, that greater adherence results in greater treatment effect on the primary and secondary outcome measures.

Timepoint [9]

Adherence: Measured at 6 months (after active intervention period) and 12 months (after passive intervention period)

Secondary outcome [10]

Depression is measured by a 2-item screening tool the Patient Health Questionnaire-2

Timepoint [10]

Baseline, 6 mnths and 12 months

Eligibility

Key inclusion criteria

People with stroke will be screened and invited to participate if they i) are within 5 years of their first stroke; ii) have been discharged from formal rehabilitation and are community-dwelling; iii) can walk, defined as ‘being able to walk 10 m across flat ground with or without a gait aid’; and, iv) are adults capable of providing consent (using the Short Portable Mental Status Questionnaire ).

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

They will be excluded if they have moderate to severe receptive aphasia as determined by a score of <7/10 on the comprehension component of the Frenchay Screening Aphasia Test (Enderby et al., 1987).
An addition to exclusions - added in March 2021- to exclude those with a walking speed of >1.4m/s and no fall in past year to ensure people with mobility or balance difficulties were included in the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Stroke survivors will be randomised into one of three groups. Walking speed will be used to stratify the allocation of participants to groups because it has been found to be associated with community ambulation (Perry et al 1995). The cut-offs for walking speed will be 0.4 m/s and 0.8 m/s. Within each of the three strata (< 0.4 versus 0.4-0.8 versus > 0.8 m/s) participants will be allocated randomly to one of two groups – the experimental or the control group. Randomisation will be conducted after the baseline assessment and concealed from the recruiter by using an automated secure website that will be operated by an off-site independent service.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random permuted blocks, of varying size.
Randomised based on 3 groups of initial walking speed [ I: <0.4m/s; II: 0.4-0.8m/s; III: >0.8m/s ]

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be analysed by a statistician who is blinded to group status. Analyses will be conducted according to the pre-defined statistical analysis plan on an intention-to-treat basis. For the primary outcome, a statistical significance level of 5% will be used. For the secondary outcomes a significance level of 1% will be used.
Primary outcome: The rate of falls will be analysed using negative binomial (or other appropriate) regression to estimate the ratio of fall rates between each of the intervention groups and the control group (Robertson et al 2005). Confounding variables such as stroke-specific impairments and demographics factors will be adjusted for, if required. Length of follow-up will be included as an exposure term in these models, i.e. the logarithm of the days of follow-up will be added as an offset.
Secondary outcomes:
The proportion of fallers in the experimental group will be compared with the control group, using logistic regression
Between-group comparisons for the continuous secondary outcome measures will be made using Analysis of Covariance (ANCOVA), adjusted for baseline covariates if appropriate. Ordinal secondary outcomes will be analysed for between-group differences using the nonparametric Mann-Whitney U statistic.

Multivariate linear regressions will be used to identify determinants of adherence based on a continuous adherence outcome measure - exercise adherence rating scale (EARS - Newman-Beinart 2016). Further, multivariate modelling will be applied to understand the impact of adherence on the primary and secondary outcome measures on a continuous scale, and dichotomised to represent 'full adherence'.
The economic evaluation will be conducted from the perspective of the health and community service provider. Incremental cost-effectiveness ratios will be calculated using multiple health outcomes, i.e. the incremental cost per a) fall prevented, b) per fall requiring medical attention avoided, c) presentation at emergency department avoided, d) hospital admission avoided, and e) QALY gained (based on the EQ5D-5L). Using the mean costs in each trial arm, and the mean health outcomes in each arm, the incremental cost per health outcome (a-e, above) of the intervention group compared to the control group will be calculated and results will be plotted on a cost- effectiveness plane. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratios taking account of joint uncertainty in costs and benefits. One way sensitivity analysis will be conducted around key variables; a cost-effectiveness acceptability curve will be plotted. A cost- effectiveness acceptability curve provides information about the probability that an intervention is cost-effective, given a decision maker’s willingness to pay for each additional health outcome gained.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

21/08/2019

Actual

21/08/2019

Date of last participant enrolment

Anticipated

21/07/2024

Actual

Date of last data collection

Anticipated

21/07/2025

Actual

Sample size

Target

370

Accrual to date

310

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,VIC

Recruitment postcode(s) [1]

2001 - Sydney

Recruitment postcode(s) [2]

2004 - Eastern Suburbs

Recruitment postcode(s) [3]

2000 - Sydney

Recruitment postcode(s) [4]

2006 - The University Of Sydney

Recruitment postcode(s) [5]

2007 - Ultimo

Recruitment postcode(s) [6]

2008 - Chippendale

Recruitment postcode(s) [7]

2009 - Pyrmont

Recruitment postcode(s) [8]

2010 - Darlinghurst

Recruitment postcode(s) [9]

2011 - Elizabeth Bay

Recruitment postcode(s) [10]

2015 - Alexandria

Recruitment postcode(s) [11]

2016 - Redfern

Recruitment postcode(s) [12]

2017 - Waterloo

Recruitment postcode(s) [13]

2019 - Banksmeadow

Recruitment postcode(s) [14]

2020 - Mascot

Recruitment postcode(s) [15]

2021 - Centennial Park

Recruitment postcode(s) [16]

2022 - Bondi Junction

Recruitment postcode(s) [17]

2023 - Bellevue Hill

Recruitment postcode(s) [18]

2024 - Bronte

Recruitment postcode(s) [19]

2025 - Woollahra

Recruitment postcode(s) [20]

2026 - Bondi

Recruitment postcode(s) [21]

2027 - Darling Point

Recruitment postcode(s) [22]

2028 - Double Bay

Recruitment postcode(s) [23]

2029 - Rose Bay

Recruitment postcode(s) [24]

2030 - Dover Heights

Recruitment postcode(s) [25]

2031 - Randwick

Recruitment postcode(s) [26]

2032 - Kingsford

Recruitment postcode(s) [27]

2033 - Kensington

Recruitment postcode(s) [28]

2034 - Coogee

Recruitment postcode(s) [29]

2035 - Maroubra

Recruitment postcode(s) [30]

2036 - Eastgardens

Recruitment postcode(s) [31]

2037 - Glebe

Recruitment postcode(s) [32]

2038 - Annandale

Recruitment postcode(s) [33]

2039 - Rozelle

Recruitment postcode(s) [34]

2040 - Leichhardt

Recruitment postcode(s) [35]

2041 - Balmain

Recruitment postcode(s) [36]

2042 - Newtown

Recruitment postcode(s) [37]

2043 - Erskineville

Recruitment postcode(s) [38]

2044 - St Peters

Recruitment postcode(s) [39]

2045 - Haberfield

Recruitment postcode(s) [40]

2048 - Stanmore

Recruitment postcode(s) [41]

2049 - Petersham

Recruitment postcode(s) [42]

2060 - North Sydney

Recruitment postcode(s) [43]

2061 - Kirribilli

Recruitment postcode(s) [44]

2062 - Cammeray

Recruitment postcode(s) [45]

2063 - Northbridge

Recruitment postcode(s) [46]

2064 - Artarmon

Recruitment postcode(s) [47]

2065 - Crows Nest

Recruitment postcode(s) [48]

2066 - Lane Cove

Recruitment postcode(s) [49]

2067 - Chatswood

Recruitment postcode(s) [50]

2068 - Castlecrag

Recruitment postcode(s) [51]

2069 - Castle Cove

Recruitment postcode(s) [52]

2070 - East Lindfield

Recruitment postcode(s) [53]

2071 - Killara

Recruitment postcode(s) [54]

2072 - Gordon

Recruitment postcode(s) [55]

2073 - Pymble

Recruitment postcode(s) [56]

2074 - Turramurra

Recruitment postcode(s) [57]

2075 - St Ives

Recruitment postcode(s) [58]

2077 - Hornsby

Recruitment postcode(s) [59]

2079 - Mount Colah

Recruitment postcode(s) [60]

2080 - Mount Kuring-Gai

Recruitment postcode(s) [61]

2081 - Berowra

Recruitment postcode(s) [62]

2082 - Berowra Creek

Recruitment postcode(s) [63]

2083 - Brooklyn

Recruitment postcode(s) [64]

2084 - Cottage Point

Recruitment postcode(s) [65]

2085 - Belrose

Recruitment postcode(s) [66]

2086 - Frenchs Forest

Recruitment postcode(s) [67]

2087 - Forestville

Recruitment postcode(s) [68]

2088 - Mosman

Recruitment postcode(s) [69]

2089 - Neutral Bay

Recruitment postcode(s) [70]

2090 - Cremorne

Recruitment postcode(s) [71]

2092 - Seaforth

Recruitment postcode(s) [72]

2093 - Manly Vale

Recruitment postcode(s) [73]

2094 - Fairlight

Recruitment postcode(s) [74]

2095 - Manly

Recruitment postcode(s) [75]

2096 - Curl Curl

Recruitment postcode(s) [76]

2097 - Collaroy

Recruitment postcode(s) [77]

2099 - Dee Why

Recruitment postcode(s) [78]

2100 - Allambie

Recruitment postcode(s) [79]

2101 - Elanora Heights

Recruitment postcode(s) [80]

2102 - Warriewood

Recruitment postcode(s) [81]

2103 - Mona Vale

Recruitment postcode(s) [82]

2104 - Bayview

Recruitment postcode(s) [83]

2105 - Church Point

Recruitment postcode(s) [84]

2106 - Newport

Recruitment postcode(s) [85]

2107 - Avalon

Recruitment postcode(s) [86]

2108 - Palm Beach

Recruitment postcode(s) [87]

2110 - Hunters Hill

Recruitment postcode(s) [88]

2111 - Gladesville

Recruitment postcode(s) [89]

2112 - Ryde

Recruitment postcode(s) [90]

2113 - Macquarie Park

Recruitment postcode(s) [91]

2114 - Meadowbank

Recruitment postcode(s) [92]

2118 - Carlingford

Recruitment postcode(s) [93]

2119 - Beecroft

Recruitment postcode(s) [94]

2120 - Pennant Hills

Recruitment postcode(s) [95]

2121 - Epping

Recruitment postcode(s) [96]

2122 - Eastwood

Recruitment postcode(s) [97]

2125 - West Pennant Hills

Recruitment postcode(s) [98]

2126 - Cherrybrook

Recruitment postcode(s) [99]

2130 - Summer Hill

Recruitment postcode(s) [100]

2151 - North Parramatta

Recruitment postcode(s) [101]

2153 - Baulkham Hills

Recruitment postcode(s) [102]

2154 - Castle Hill

Recruitment postcode(s) [103]

2158 - Dural

Recruitment postcode(s) [104]

2159 - Arcadia

Recruitment postcode(s) [105]

2203 - Dulwich Hill

Recruitment postcode(s) [106]

2204 - Marrickville

Recruitment postcode(s) [107]

2205 - Arncliffe

Recruitment postcode(s) [108]

2207 - Bexley

Recruitment postcode(s) [109]

2216 - Banksia

Recruitment postcode(s) [110]

2217 - Beverley Park

Recruitment postcode(s) [111]

2219 - Dolls Point

Recruitment postcode(s) [112]

2580 - Bannaby

Recruitment postcode(s) [113]

2581 - Bellmount Forest

Recruitment postcode(s) [114]

2582 - Bango

Recruitment postcode(s) [115]

2600 - Canberra

Recruitment postcode(s) [116]

2601 - City

Recruitment postcode(s) [117]

2602 - Ainslie

Recruitment postcode(s) [118]

2603 - Forrest

Recruitment postcode(s) [119]

2604 - Kingston

Recruitment postcode(s) [120]

2605 - Curtin

Recruitment postcode(s) [121]

2606 - Chifley

Recruitment postcode(s) [122]

2607 - Mawson

Recruitment postcode(s) [123]

2607 - Farrer

Recruitment postcode(s) [124]

2609 - Fyshwick

Recruitment postcode(s) [125]

2611 - Coree

Recruitment postcode(s) [126]

2612 - Braddon

Recruitment postcode(s) [127]

2614 - Aranda

Recruitment postcode(s) [128]

2615 - Charnwood

Recruitment postcode(s) [129]

2617 - Belconnen

Recruitment postcode(s) [130]

2618 - Hall

Recruitment postcode(s) [131]

2619 - Jerrabomberra

Recruitment postcode(s) [132]

2620 - Beard

Recruitment postcode(s) [133]

2621 - Anembo

Recruitment postcode(s) [134]

2622 - Araluen

Recruitment postcode(s) [135]

2623 - Captains Flat

Recruitment postcode(s) [136]

2720 - Argalong

Recruitment postcode(s) [137]

2900 - Greenway

Recruitment postcode(s) [138]

2902 - Kambah

Recruitment postcode(s) [139]

2903 - Erindale Centre

Recruitment postcode(s) [140]

2904 - Fadden

Recruitment postcode(s) [141]

2905 - Bonython

Recruitment postcode(s) [142]

2906 - Banks

Recruitment postcode(s) [143]

2911 - Crace

Recruitment postcode(s) [144]

2912 - Gungahlin

Recruitment postcode(s) [145]

2913 - Casey

Recruitment postcode(s) [146]

2914 - Amaroo

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Cumberland Campus | 75 East Street Lidcombe | 2141 NSW

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Macquarie University

Address [1]

Faculty of Medicine and Health Sciences
Level 3, 75 Talavera Road
Macquarie University NSW 2109, Australia

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

University of Canberra

Address [2]

12 University Drive, Bruce Australian Capital Territory 2617

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Monash University

Address [3]

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREC Macquarie University

Ethics committee address [1]

Balaclava Road, North Ryde New South Wales 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2015

Approval date [1]

17/06/2015

Ethics approval number [1]

Ethics approval number: 5201500456

Summary

Brief summary

Stroke survivors fall often with fall rates of more than twice that of the general older population, placing an enormous economic burden on the national health

system and society in general. The aim of Falls After Stroke Trial (FAST) is to test the effect of home-based, tailored intervention to reduce falls. A sample of community-dwelling stroke (n=370) survivors who have completed formal rehabilitation will be randomly assigned to an experimental group (habit-forming exercise and safety training), or a control group (usual care). The primary outcome measures will be falls recorded daily by the participants and monitored monthly by a researcher blinded to group allocation. Secondary outcomes will be community participation, balance, self-efficacy, mobility, physical activity, health-related quality of life healthcare utilisation and costs.

Trial website

www.faststudy.com.au

Trial related presentations / publications

none yet

Public notes

Contacts

Principal investigator

Name

Prof Lindy Clemson

Address

The University of Sydney
Cumberland Campus | 75 East Street Lidcombe | 2141 NSW

Country

Australia

Phone

+61293519372

Fax

[email protected]

Contact person for public queries

Name

Lindy Clemson

Address

The University of Sydney
Cumberland Campus | 75 East Street Lidcombe | 2141 NSW

Country

Australia

Phone

+61293519372

Fax

[email protected]

Contact person for scientific queries

Name

Lindy Clemson

Address

The University of Sydney
Cumberland Campus | 75 East Street Lidcombe | 2141 NSW

Country

Australia

Phone

+61293519372

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

There is no plan to share IPD. Participants are providing consent only for the research team to access their data and all publications or reporting will occur in a format that will not allow personal identification. We are not asking for ethical application to share data, respecting the privacy of the participants in this trial.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details
2919	Informed consent form			[email protected]
2920	Ethical approval			[email protected]
3967	Study protocol	41. Dean, C., Clemson, L., Ada, L., Scrivener, K., Lannin, N., Mikolaizak, S., . . . Preston, E. (2021). Home-based, tailored intervention for reducing falls after stroke (FAST): Protocol for a randomized trial. International Journal of Stroke. 16(9), 1053-1058 doi:10.1177/1747493021991990 PMID: 33568018	https://journals.sagepub.com/doi/abs/10.1177/1747493021991990	[email protected]	this is now published
3968	Statistical analysis plan			[email protected]	this has not been published yet. Once published, i... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Home-based, tailored intervention for reducing falls after stroke (FAST): Protocol for a randomized trial.	2021	https://dx.doi.org/10.1177/1747493021991990
Dimensions AI	Research Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry	2024	https://doi.org/10.1016/j.jphys.2024.02.015

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