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Trial registered on ANZCTR


Registration number
ACTRN12615000728538
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
15/07/2015
Date last updated
16/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based, tailored intervention for reducing falls after stroke: the Falls After Stroke Trial (FAST)
Scientific title
Home-based, tailored intervention for reducing falls after stroke: the Falls After Stroke Trial (FAST)
Secondary ID [1] 286997 0
None
Universal Trial Number (UTN)
Trial acronym
FAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 295462 0
Falls 295559 0
Condition category
Condition code
Stroke 295716 295716 0 0
Ischaemic
Stroke 295729 295729 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 295827 295827 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community dwelling-stroke survivors will be randomly assigned to one of the two groups: the experimental or the control group. The experimental group will receive a home-based, tailored intervention consisting of habit-forming exercise and/or 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 (Clemson et al., 2012). 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, monitoring and positive reinforcement will be used to enhance the performance of these activities and the self-efficacy of the participants.
The safety intervention will focus on environmental adaptations to reduce fall hazards and protective behaviours to reduce risk. The Westmead Home Safety Assessment (Clemson et al 1999), and the Falls Behavioural Scale for Older People, validated by Clemson and colleagues (Clemson et al., 2008a), will be used to identify environmental hazards, as well as risks, so that the participants and therapist can generate solutions.
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. All home visits will be approximately 1 hour duration and all home visits and phone calls will be delivered by a physiotherapists or an occupational therapist with experience in neurological rehabilitation. The therapists delivering the intervention and participants will keep exercise logs to monitor adherence.
Intervention code [1] 292203 0
Prevention
Intervention code [2] 292204 0
Rehabilitation
Intervention code [3] 292293 0
Treatment: Other
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 (NSF, 2012).
Control group
Active

Outcomes
Primary outcome [1] 295435 0
The primary outcome measure will be falls defined according to a recent consensus statements and Cochrane review recommendations as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level” (Lamb et al., 2005). Participants will self report using monthly falls calendars
Timepoint [1] 295435 0
12 months
Secondary outcome [1] 315574 0
Balance will be measured using the Berg Balance Scale (Berg et al 1992). It has demonstrate good test-retest reliability and validity in measuring balance after stroke (Berg et al 1995).
Timepoint [1] 315574 0
0, 6 and 12 months
Secondary outcome [2] 315575 0
Self-efficacy will be measured using the Activities Specific Balance Confidence Scale It has demonstrated good test-retest reliability and adequate internal consistency (Powell and Myers, 1995; ).
Timepoint [2] 315575 0
0, 6 and 12 months
Secondary outcome [3] 315576 0
Mobility will be assessed using the 6-min walk test (6MWT) The 6MWT will be conducted according to the recently updated guidelines (Holland et al, 2014). It is commonly used as a functional submaximal measure of oxygen uptake and exercise capacity (Solway et al., 2001) and is a valid and reliable clinical measure of walking ability in stroke survivors (Fulk et al., 2008).
Timepoint [3] 315576 0
0, 6 and 12 months
Secondary outcome [4] 315577 0
Habitual physical activity will be assessed using the Incidental and Planned Exercise Questionnaire (IPEQ) which has been validated and which provide estimates of the frequency and duration of planned and casual day-to-day activities (Delbare et al 2010) and the ActivPALTM, an accelerometer-based monitor to measure physical activity for 7 days. Time on feet, time in sitting and lying and steps per day will be analysed (Grant et al., 2008).
Timepoint [4] 315577 0
0, 6 and 12 months
Secondary outcome [5] 315578 0
Community participation will be measured using the Late-Life Function and Disability Instrument which measures limitation and frequency of participation in life tasks across personal, social and community domains (Sayers et al., 2004).
Timepoint [5] 315578 0
0, 6 and 12 months
Secondary outcome [6] 315579 0
Health-related quality of life will be measured using the EuroQual-5D (EQ-5D) (Kind et al 2005), which provides a measure of overall health using a visual analogue scale.
Timepoint [6] 315579 0
0, 6 and 12 months
Secondary outcome [7] 315580 0
Healthcare utilisation and costs: The use of public and private healthcare resources (eg Inpatient hospital admissions, emergency department presentations and other health and community service contact) will be recorded as part of the monthly falls calendars over the 12-month study period. Pharmaceutical use will also be collected. The cost of implementing the intervention program (including staff costs, training, capital costs and consumables) will be obtained from trial data and financial records. Resources will be costed using published government sources where available (Pharmaceutical Benefits Scheme unit costs; Medicare Benefits Schedule, and the National Hospital Costs Data collection). We will also utilise published data (Farag et al 2013) to provide estimates of allied health service and of out of pocket costs to patient and family.
Timepoint [7] 315580 0
6 and 12 months
Secondary outcome [8] 315750 0
Balance will also be measured using the Step Test (Hill et al 1996). The test has demonstrate good test-retest reliability and validity in measuring balance after stroke ( Hill et al 1996, Blennerhasset et al 2009)
Timepoint [8] 315750 0
0, 6 and 12 months
Secondary outcome [9] 315751 0
Self-efficacy will also be measured using the Modified Falls Efficacy Scale to measure confidence in performing daily activity without risk of falling. It has demonstrated good test-retest reliability and adequate internal consistency (Lamb et al., 2005).
Timepoint [9] 315751 0
0, 6 and 12 months
Secondary outcome [10] 315753 0
Mobility will also be assessed using the 10-m walk test (self-selected and fast speed: step length, and cadence). The 10-m walk test will be conducted with a moving start and finish to take into account any acceleration and deceleration.
Timepoint [10] 315753 0
0, 6 and 12 months
Secondary outcome [11] 315754 0
Habitual physical activity will also be assessed using the ActivPALTM, an accelerometer-based monitor to measure physical activity for 7 days. Time on feet, time in sitting and lying and steps per day will be analysed (Grant et al., 2008).
Timepoint [11] 315754 0
0, 6 and 12 months

Eligibility
Key inclusion criteria
People with stroke will be screened and invited to participate if they:

a) are within 2 years of their first stroke (either ischaemic or haemorrhagic
b) have been discharged from formal rehabilitation and are community-dwelling
c) can walk, defined as ‘being able to walk 10 m across flat ground with or without a gait aid’
d)are adults capable of providing consent (ie, score greater than or equal to 20 on Mini-Mental State Examination score, Folstein et al 1975)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They will be excluded if they:

a) have moderate to severe receptive aphasia as determined by a score of less than 25/30 on the Frenchay Screening Aphasia Test (Enderby et al., 1987).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization 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)
Subjects will be randomised into one of the two groups using a computerised sequence generation. The randomisation will be also stratified by two factors:

1. Sites (NSW and VIC) so that participants in each state will be randomised separately;

2. Walking speed will be used to stratify 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 three strata (<0.4 m/s versus 0.4-0.8 m/s versus >0.8 m/s) participants will be allocated randomly to one of two groups - the experimental or the control group.
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
The sample size was calculated for the primary outcome. A negative binomial model for the number of falls was assumed, and the formula for sample size in Zhu and Lakkis (2014) used. The result was confirmed using simulation. Based on the data available in Dean et al (2012) with 1.8 falls per person year and dispersion parameter (called alternatively k or alpha) of 0.54, 117 participants per group will give 80% power to detect a 33% reduction (Incidence Rate Ratio 0.67) in the rate of falls over the 12 month follow up period. Allowing for 15% loss to follow-up due to death or withdrawal from the study, we plan to recruit 135 per group or 270 participants in total. Experience from our previous work indicates that, with this sample size, power will also be sufficient to detect meaningful between-group differences for all other outcome measures.


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 number of falls per person-year 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. The proportion of fallers in the experimental group will be compared with the control group, using logistic regression.
Secondary outcomes:
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.
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
Not yet 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)
NSW,VIC

Funding & Sponsors
Funding source category [1] 291560 0
University
Name [1] 291560 0
Macquarie University
Address [1] 291560 0
Dept of Health Professions
Macquarie university
Ground Floor
75 Talavera Rd
Macquarie Park
NSW 2109
Country [1] 291560 0
Australia
Primary sponsor type
Individual
Name
Catherine Dean
Address
Ground Floor 75 Talavera Road
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 290235 0
University
Name [1] 290235 0
Macquarie University
Address [1] 290235 0
Dept of health Professions
Macquarie University
Ground FLoor
75 Talavera Rd
Macquarie Park NSW 2109
Country [1] 290235 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293102 0
Macquarie University Human Research Ethics Committee (HREC Medical Sciences)
Ethics committee address [1] 293102 0
Building C5C East
Macquarie University
NSW 2109 Australia
Ethics committee country [1] 293102 0
Australia
Date submitted for ethics approval [1] 293102 0
Approval date [1] 293102 0
17/06/2015
Ethics approval number [1] 293102 0
5201500456

Summary
Brief summary
The aim of the Falls After Stroke Trial (FAST) is to test the effect of home-based, tailored intervention to reduce falls. A sample of community-dwelling stroke survivors who have finished formal rehabilitation, and therefore are at a high risk of falling again will be randomly assigned to one of two groups: an experimental group (habit-forming exercise and safety training), or a control group (usual care which is no active intervention).

The primary hypothesis is that the home-based, tailored intervention will be effective in reducing both the proportion of people falling and rate of falls over a one-year period in stroke survivors living in the community.

The secondary hypotheses are:
2. That home-based, tailored intervention will also be effective in improving: balance, self-efficacy, mobility, physical activity, community participation, and health-related quality of life.
3. That home-based, tailored intervention will reduce healthcare utilisation and be cost-effective.
Trial website
Trial related presentations / publications
Public notes
Pilot feasibility work will be undertaken prior to launch of major trial. Funding for feasibility work provided by Macquarie University, major trial will require additional funding in order to proceed. The feasibility trial will be registered separately.

Contacts
Principal investigator
Name 58446 0
Prof Catherine Dean
Address 58446 0
Ground Floor 75 Talavera Road
Macquarie University
NSW 2109
Country 58446 0
Australia
Phone 58446 0
+61 2 9850 6620
Fax 58446 0
Email 58446 0
catherine.dean@mq.edu.au
Contact person for public queries
Name 58447 0
Prof Catherine Dean
Address 58447 0
Ground Floor 75 Talavera Road
Macquarie University
NSW 2109
Country 58447 0
Australia
Phone 58447 0
+61 2 9850 6620
Fax 58447 0
Email 58447 0
catherine.dean@mq.edu.au
Contact person for scientific queries
Name 58448 0
Prof Catherine Dean
Address 58448 0
Ground Floor 75 Talavera Road
Macquarie University
NSW 2109
Country 58448 0
Australia
Phone 58448 0
+61 2 9850 6620
Fax 58448 0
Email 58448 0
catherine.dean@mq.edu.au

No data has been provided for results reporting
Summary results
Not applicable