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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
2/03/2020
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] 298642 0
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 313524 0
Community participation 313525 0
Self efficacy 313526 0
Balance 313527 0
Mobility 313528 0
Physical Activity 313529 0
Health related quality of life 313530 0
Health care utilisation and costs 313846 0
Condition category
Condition code
Stroke 311961 311961 0 0
Haemorrhagic
Stroke 311962 311962 0 0
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] 314907 0
Treatment: Other
Intervention code [2] 314908 0
Lifestyle
Intervention code [3] 314909 0
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] 320622 0
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] 320622 0
Monthly between 0-12 months post randomisation
Secondary outcome [1] 372238 0
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] 372238 0
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] 372296 0
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] 372296 0
Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [3] 372297 0
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] 372297 0
Measured from baseline, at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [4] 372298 0
Balance measured using the balance component of the Short Physical Performance Battery and the Step test

Timepoint [4] 372298 0
Measured from baseline, at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [5] 372299 0
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] 372299 0
Measured from baseline, at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [6] 372300 0
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] 372300 0
Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [7] 372301 0
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] 372301 0
Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [8] 373259 0
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] 373259 0
Measured from baseline,at 6 months (after active intervention period) and 12 months (after passive intervention period)
Secondary outcome [9] 373270 0
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] 373270 0
Adherence: Measured at 6 months (after active intervention period) and 12 months (after passive intervention period)

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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They will be excluded if they have moderate to severe receptive aphasia as determined by a score of <9/10 on the comprehension component of the Frenchay Screening Aphasia Test (Enderby et al., 1987).

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 26966 0
2000 - Sydney
Recruitment postcode(s) [2] 26964 0
2001 - Sydney
Recruitment postcode(s) [3] 26965 0
2004 - Eastern Suburbs
Recruitment postcode(s) [4] 26967 0
2006 - The University Of Sydney
Recruitment postcode(s) [5] 26968 0
2007 - Ultimo
Recruitment postcode(s) [6] 26969 0
2008 - Chippendale
Recruitment postcode(s) [7] 26970 0
2009 - Pyrmont
Recruitment postcode(s) [8] 26971 0
2010 - Darlinghurst
Recruitment postcode(s) [9] 26972 0
2011 - Elizabeth Bay
Recruitment postcode(s) [10] 26973 0
2015 - Alexandria
Recruitment postcode(s) [11] 26974 0
2016 - Redfern
Recruitment postcode(s) [12] 26975 0
2017 - Waterloo
Recruitment postcode(s) [13] 26976 0
2019 - Banksmeadow
Recruitment postcode(s) [14] 26977 0
2020 - Mascot
Recruitment postcode(s) [15] 26978 0
2021 - Centennial Park
Recruitment postcode(s) [16] 26979 0
2022 - Bondi Junction
Recruitment postcode(s) [17] 26980 0
2023 - Bellevue Hill
Recruitment postcode(s) [18] 26981 0
2024 - Bronte
Recruitment postcode(s) [19] 26982 0
2025 - Woollahra
Recruitment postcode(s) [20] 26983 0
2026 - Bondi
Recruitment postcode(s) [21] 26984 0
2027 - Darling Point
Recruitment postcode(s) [22] 26985 0
2028 - Double Bay
Recruitment postcode(s) [23] 26986 0
2029 - Rose Bay
Recruitment postcode(s) [24] 26987 0
2030 - Dover Heights
Recruitment postcode(s) [25] 26988 0
2031 - Randwick
Recruitment postcode(s) [26] 26989 0
2032 - Kingsford
Recruitment postcode(s) [27] 26990 0
2033 - Kensington
Recruitment postcode(s) [28] 26991 0
2034 - Coogee
Recruitment postcode(s) [29] 26992 0
2035 - Maroubra
Recruitment postcode(s) [30] 26993 0
2036 - Eastgardens
Recruitment postcode(s) [31] 26994 0
2037 - Glebe
Recruitment postcode(s) [32] 26995 0
2038 - Annandale
Recruitment postcode(s) [33] 26998 0
2039 - Rozelle
Recruitment postcode(s) [34] 26999 0
2040 - Leichhardt
Recruitment postcode(s) [35] 27000 0
2041 - Balmain
Recruitment postcode(s) [36] 27001 0
2042 - Newtown
Recruitment postcode(s) [37] 27002 0
2043 - Erskineville
Recruitment postcode(s) [38] 27003 0
2044 - St Peters
Recruitment postcode(s) [39] 27004 0
2045 - Haberfield
Recruitment postcode(s) [40] 27005 0
2048 - Stanmore
Recruitment postcode(s) [41] 27006 0
2049 - Petersham
Recruitment postcode(s) [42] 27009 0
2060 - North Sydney
Recruitment postcode(s) [43] 27010 0
2061 - Kirribilli
Recruitment postcode(s) [44] 27011 0
2062 - Cammeray
Recruitment postcode(s) [45] 27012 0
2063 - Northbridge
Recruitment postcode(s) [46] 27013 0
2064 - Artarmon
Recruitment postcode(s) [47] 27014 0
2065 - Crows Nest
Recruitment postcode(s) [48] 27015 0
2066 - Lane Cove
Recruitment postcode(s) [49] 27016 0
2067 - Chatswood
Recruitment postcode(s) [50] 27017 0
2068 - Castlecrag
Recruitment postcode(s) [51] 27018 0
2069 - Castle Cove
Recruitment postcode(s) [52] 27019 0
2070 - East Lindfield
Recruitment postcode(s) [53] 27020 0
2071 - Killara
Recruitment postcode(s) [54] 27021 0
2072 - Gordon
Recruitment postcode(s) [55] 27022 0
2073 - Pymble
Recruitment postcode(s) [56] 27023 0
2074 - Turramurra
Recruitment postcode(s) [57] 27024 0
2075 - St Ives
Recruitment postcode(s) [58] 27025 0
2077 - Hornsby
Recruitment postcode(s) [59] 27026 0
2079 - Mount Colah
Recruitment postcode(s) [60] 27027 0
2080 - Mount Kuring-Gai
Recruitment postcode(s) [61] 27028 0
2081 - Berowra
Recruitment postcode(s) [62] 27029 0
2082 - Berowra Creek
Recruitment postcode(s) [63] 27030 0
2083 - Brooklyn
Recruitment postcode(s) [64] 27031 0
2084 - Cottage Point
Recruitment postcode(s) [65] 27032 0
2085 - Belrose
Recruitment postcode(s) [66] 27033 0
2086 - Frenchs Forest
Recruitment postcode(s) [67] 27034 0
2087 - Forestville
Recruitment postcode(s) [68] 27035 0
2088 - Mosman
Recruitment postcode(s) [69] 27036 0
2089 - Neutral Bay
Recruitment postcode(s) [70] 27037 0
2090 - Cremorne
Recruitment postcode(s) [71] 27038 0
2092 - Seaforth
Recruitment postcode(s) [72] 27039 0
2093 - Manly Vale
Recruitment postcode(s) [73] 27040 0
2094 - Fairlight
Recruitment postcode(s) [74] 27041 0
2095 - Manly
Recruitment postcode(s) [75] 27042 0
2096 - Curl Curl
Recruitment postcode(s) [76] 27043 0
2097 - Collaroy
Recruitment postcode(s) [77] 27044 0
2099 - Dee Why
Recruitment postcode(s) [78] 27045 0
2100 - Allambie
Recruitment postcode(s) [79] 27046 0
2101 - Elanora Heights
Recruitment postcode(s) [80] 27047 0
2102 - Warriewood
Recruitment postcode(s) [81] 27048 0
2103 - Mona Vale
Recruitment postcode(s) [82] 27049 0
2104 - Bayview
Recruitment postcode(s) [83] 27050 0
2105 - Church Point
Recruitment postcode(s) [84] 27051 0
2106 - Newport
Recruitment postcode(s) [85] 27052 0
2107 - Avalon
Recruitment postcode(s) [86] 27053 0
2108 - Palm Beach
Recruitment postcode(s) [87] 27054 0
2110 - Hunters Hill
Recruitment postcode(s) [88] 27055 0
2111 - Gladesville
Recruitment postcode(s) [89] 27056 0
2112 - Ryde
Recruitment postcode(s) [90] 27057 0
2113 - Macquarie Park
Recruitment postcode(s) [91] 27058 0
2114 - Meadowbank
Recruitment postcode(s) [92] 27059 0
2118 - Carlingford
Recruitment postcode(s) [93] 27060 0
2119 - Beecroft
Recruitment postcode(s) [94] 27061 0
2120 - Pennant Hills
Recruitment postcode(s) [95] 27062 0
2121 - Epping
Recruitment postcode(s) [96] 27063 0
2122 - Eastwood
Recruitment postcode(s) [97] 27064 0
2125 - West Pennant Hills
Recruitment postcode(s) [98] 27065 0
2126 - Cherrybrook
Recruitment postcode(s) [99] 27066 0
2130 - Summer Hill
Recruitment postcode(s) [100] 27067 0
2151 - North Parramatta
Recruitment postcode(s) [101] 27068 0
2153 - Baulkham Hills
Recruitment postcode(s) [102] 27069 0
2154 - Castle Hill
Recruitment postcode(s) [103] 27070 0
2158 - Dural
Recruitment postcode(s) [104] 27071 0
2159 - Arcadia
Recruitment postcode(s) [105] 27072 0
2203 - Dulwich Hill
Recruitment postcode(s) [106] 27073 0
2204 - Marrickville
Recruitment postcode(s) [107] 27074 0
2205 - Arncliffe
Recruitment postcode(s) [108] 27075 0
2207 - Bexley
Recruitment postcode(s) [109] 27076 0
2216 - Banksia
Recruitment postcode(s) [110] 27077 0
2217 - Beverley Park
Recruitment postcode(s) [111] 27078 0
2219 - Dolls Point
Recruitment postcode(s) [112] 27079 0
2580 - Bannaby
Recruitment postcode(s) [113] 27080 0
2581 - Bellmount Forest
Recruitment postcode(s) [114] 27081 0
2582 - Bango
Recruitment postcode(s) [115] 27082 0
2600 - Canberra
Recruitment postcode(s) [116] 27083 0
2601 - City
Recruitment postcode(s) [117] 27084 0
2602 - Ainslie
Recruitment postcode(s) [118] 27085 0
2603 - Forrest
Recruitment postcode(s) [119] 27086 0
2604 - Kingston
Recruitment postcode(s) [120] 27087 0
2605 - Curtin
Recruitment postcode(s) [121] 27088 0
2606 - Chifley
Recruitment postcode(s) [122] 27090 0
2607 - Farrer
Recruitment postcode(s) [123] 27089 0
2607 - Mawson
Recruitment postcode(s) [124] 27091 0
2609 - Fyshwick
Recruitment postcode(s) [125] 27092 0
2611 - Coree
Recruitment postcode(s) [126] 27093 0
2612 - Braddon
Recruitment postcode(s) [127] 27094 0
2614 - Aranda
Recruitment postcode(s) [128] 27095 0
2615 - Charnwood
Recruitment postcode(s) [129] 27096 0
2617 - Belconnen
Recruitment postcode(s) [130] 27097 0
2618 - Hall
Recruitment postcode(s) [131] 27098 0
2619 - Jerrabomberra
Recruitment postcode(s) [132] 27099 0
2620 - Beard
Recruitment postcode(s) [133] 27100 0
2621 - Anembo
Recruitment postcode(s) [134] 27101 0
2622 - Araluen
Recruitment postcode(s) [135] 27102 0
2623 - Captains Flat
Recruitment postcode(s) [136] 27103 0
2720 - Argalong
Recruitment postcode(s) [137] 27104 0
2900 - Greenway
Recruitment postcode(s) [138] 27105 0
2902 - Kambah
Recruitment postcode(s) [139] 27106 0
2903 - Erindale Centre
Recruitment postcode(s) [140] 27107 0
2904 - Fadden
Recruitment postcode(s) [141] 27108 0
2905 - Bonython
Recruitment postcode(s) [142] 27111 0
2906 - Banks
Recruitment postcode(s) [143] 27112 0
2911 - Crace
Recruitment postcode(s) [144] 27113 0
2912 - Gungahlin
Recruitment postcode(s) [145] 27114 0
2913 - Casey
Recruitment postcode(s) [146] 27115 0
2914 - Amaroo

Funding & Sponsors
Funding source category [1] 303183 0
Government body
Name [1] 303183 0
NHMRC
Address [1] 303183 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1] 303183 0
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] 303220 0
None
Name [1] 303220 0
Address [1] 303220 0
Country [1] 303220 0
Other collaborator category [1] 280833 0
University
Name [1] 280833 0
Macquarie University
Address [1] 280833 0
Faculty of Medicine and Health Sciences
Level 3, 75 Talavera Road
Macquarie University NSW 2109, Australia
Country [1] 280833 0
Australia
Other collaborator category [2] 280836 0
University
Name [2] 280836 0
University of Canberra
Address [2] 280836 0
12 University Drive, Bruce Australian Capital Territory 2617
Country [2] 280836 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303745 0
HREC Macquarie University
Ethics committee address [1] 303745 0
Balaclava Road, North Ryde New South Wales 2109
Ethics committee country [1] 303745 0
Australia
Date submitted for ethics approval [1] 303745 0
15/05/2015
Approval date [1] 303745 0
17/06/2015
Ethics approval number [1] 303745 0
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 94650 0
Prof Lindy Clemson
Address 94650 0
The University of Sydney
Cumberland Campus | 75 East Street Lidcombe | 2141 NSW
Country 94650 0
Australia
Phone 94650 0
+61293519372
Fax 94650 0
Email 94650 0
lindy.clemson@sydney.edu.au
Contact person for public queries
Name 94651 0
Prof Lindy Clemson
Address 94651 0
The University of Sydney
Cumberland Campus | 75 East Street Lidcombe | 2141 NSW
Country 94651 0
Australia
Phone 94651 0
+61293519372
Fax 94651 0
Email 94651 0
lindy.clemson@sydney.edu.au
Contact person for scientific queries
Name 94652 0
Prof Lindy Clemson
Address 94652 0
The University of Sydney
Cumberland Campus | 75 East Street Lidcombe | 2141 NSW
Country 94652 0
Australia
Phone 94652 0
+61293519372
Fax 94652 0
Email 94652 0
lindy.clemson@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2919 0
Informed consent form
Citation [1] 2919 0
Link [1] 2919 0
Email [1] 2919 0
lindy.clemson@sydney.edu.au
Other [1] 2919 0
Attachment [1] 2919 0
Type [2] 2920 0
Ethical approval
Citation [2] 2920 0
Link [2] 2920 0
Email [2] 2920 0
lindy.clemson@sydney.edu.au
Other [2] 2920 0
Attachment [2] 2920 0
Type [3] 3967 0
Study protocol
Citation [3] 3967 0
Link [3] 3967 0
Email [3] 3967 0
lindy.clemson@sydney.edu.au
Other [3] 3967 0
this is not published yet, will be made available as soon as it has been accepted by a peer-reviewed journal
Attachment [3] 3967 0
Type [4] 3968 0
Statistical analysis plan
Citation [4] 3968 0
Link [4] 3968 0
Email [4] 3968 0
lindy.clemson@sydney.edu.au
Other [4] 3968 0
this has not been published yet. Once published, it will be made available
Attachment [4] 3968 0
Summary results
No Results