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Trial registered on ANZCTR


Registration number
ACTRN12616001186448
Ethics application status
Approved
Date submitted
22/06/2016
Date registered
29/08/2016
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results information initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
PlaTFORM: PrevenTing Falls in a high risk, vision impaired population through specialist ORientation and Mobility services: a randomised trial
Scientific title
PlaTFORM: PrevenTing Falls in a high risk, vision impaired population through specialist ORientation and Mobility services: a randomised trial
Secondary ID [1] 289486 0
NHMRC APP1108176
Universal Trial Number (UTN)
U1111-1184-6675
Trial acronym
PlaTFORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older people with vision impairment and their physical performance 299178 0
Fear of falling 299179 0
Condition category
Condition code
Injuries and Accidents 299188 299188 0 0
Other injuries and accidents
Eye 299254 299254 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LiFE program is a structured approach to improving the balance and strength of people at high risk of falls. The program is designed in such a way that participants incorporate the 8 balance and 7 strength activities into their daily lives and routines to gradually form habits (Clemson, Munro, Fiatarone Singh 2013). Lally and Gardner (2011) argue that habit formation is largely dependent on repetitive behavior being conducted in a consistent environment. Participants of the LiFE program are taught these activities within their own home thus maintaining the consistency of the environment (Clemson et al 2012; Lally and Gardner 2011). Additionally daily routines provide the ‘cue’ that participants need to promote the performance of the activity (Lally and Gardner 2011).
The balance activities are the tandem stand, tandem walking, one-leg stand, leaning from side-to-side, leaning forwards and backwards, stepping over objects, stepping over objects sideways and stepping in different directions. The strength activities aim to increase the load on the legs and include; bending knees, sit to stand, standing on toes and heels, walking up stairs, walking sideways and tightening muscles (Clemson, Munro, Fiatarone Singh 2013). These activities will be taught by Orientation and Mobility Instructors employed by Guide Dogs NSW/ACT. These instructors are familiar in working with the vision impaired population and will thus appropriately tailor these activities to the needs of the participants. The LIFE program will be adminstered over 5 home visits (with one each week) as well as 2 booster visits and 2 phone calls (one each fortnight as the participant becomes more familiar with the program) over the course of 3 months. It is expected that each of the 5 home visits will be conducted over an hour, whereas the booster visits and phone calls should not take longer than half an hour.
Overall the duration of the program is 3 months. However there will also be a follow up assessment at the end of the 3 month period and at 12 months from the baseline assessment, to measure any improvements to the participants’ balance and strength abilities. Thus the total duration of the study is 12 months.
Intervention code [1] 295073 0
Behaviour
Comparator / control treatment
A control group of Guide Dogs NSW/ACT clients will receive only usual care from the Orientation and Mobility Instructors, and will also be assessed at baseline and 3 and 12 months.
Usual care consists of an orientation and mobility program which is available to all Guide Dogs clients. Such a program usually involves training in how to successfully navigate and travel to a location for a desired activity, for example catching a bus to the shops. By definition and orientation and mobility program will provide instruction that can help you develop or relearn the skills and concepts you need to travel safely and independently within your home and in the community. It is goal specific. "Orientation" refers to the ability to know where you are and where you want to go, whether you're moving from one room to another or walking downtown for a shopping trip. "Mobility" refers to the ability to move safely, efficiently, and effectively from one place to another, such as being able to walk without tripping or falling, cross streets, and use public transportation.
Control group
Active

Outcomes
Primary outcome [1] 298695 0
Number of falls over 12 months following randomisation, based on prospective, self-reporting by monthly falls calendars.
Timepoint [1] 298695 0
Falls will be recorded prospectively for 12 months using monthly calendars with active follow-up,
Primary outcome [2] 298822 0
Function as measured by the Late Life Function and Disability Index (LLFDI) which comprises an overall score for functioning (with lower extremity subscale),
Timepoint [2] 298822 0
12 months after randomisation
Secondary outcome [1] 324984 0
Falls requiring medical attention. This will be assessed based on the rate of falls over the 12 months following randomisation, based on self-reporting by monthly falls calendars. The falls requiring medical care will be identified after interview with the participant to elicit detailed information about the fall.
Timepoint [1] 324984 0
Falls will be recorded prospectively for 12 months using monthly calendars with active follow-up,
Secondary outcome [2] 324986 0
The EuroQual EQ-5D-5L will be used to assess quality of life and is a standard instrument found to be able to measure the impact of falls, independent of chronic conditions. This is part of the economic evaluation.
Timepoint [2] 324986 0
12 months after randomisation
Secondary outcome [3] 327150 0
Falls per steps taken using the prospective falls data and the number of steps taken, estimated by actigraphy at baseline, 3 months and 12 months.
Timepoint [3] 327150 0
Falls will be recorded prospectively for 12 months using monthly calendars with active follow-up, Steps will be estimated based on measurements at 3 timepoints.

Eligibility
Key inclusion criteria
Clients of Guide Dogs NSW/ACT with vision impairment severe enough to interfere with activities of daily living, aged 50 years or older, living in the community or self-care unit of a retirement village, able to understand English well enough to undertake study procedures, no more than two errors on the Short Portable Mental Status Questionnaire and no diagnosis of dementia, not scheduled for cataract surgery in the next 12 months,
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nursing home or hostel residents, those currently engaging in a falls or exercise program.

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)
The randomisation sequence will be generated by an investigator not directly involved in participant recruitment or data entry for falls calendars. This sequence will be uploaded into the on-line database and the randomisation enabled after completion of the baseline assessment. To minimise observational bias, the research assistants conducting the 12-month assessments will be masked to group allocation. It is not possible to mask the participants to the type of intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be determined using an on-line randomisation process (REDCap).
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
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
As fall rates will be compared between groups using incidence rate ratios (IRR) from negative binomial regression models, we conducted an analysis of statistical power using the R software package. A total of 500 participants (250 per group) will be required to provide 90% power to detect as significant, at the 5% level, a 30% between-group difference in fall rates (ie IRR = 0.70). For the power calculation we used coefficients from the previous trial of falls prevention in people with low vision. Alpha (a measure of over-dispersion in the negative binomial regression model) was assumed to be 0.8. We assumed the control group rate of falls would be the same as that found in AI Gleeson’s study in the same population 0.1242 falls /person month over the 12-month follow-up period. We will recruit 588 participants, to allow for 15% drop-out.

Recruitment
Recruitment status
Active, not 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

Funding & Sponsors
Funding source category [1] 293882 0
Government body
Name [1] 293882 0
National Health and Medical Research Council
Address [1] 293882 0
Level 1, 16 Marcus Clarke Street
Canberra, ACT 2601
Country [1] 293882 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 3, 50 Bridge Street,
Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 292710 0
None
Name [1] 292710 0
Address [1] 292710 0
Country [1] 292710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295300 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295300 0
Level 6, Jane Foss Russell Building
University of Sydney, NSW 2006
Ethics committee country [1] 295300 0
Australia
Date submitted for ethics approval [1] 295300 0
08/07/2016
Approval date [1] 295300 0
20/10/2016
Ethics approval number [1] 295300 0
Ethics committee name [2] 295301 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [2] 295301 0
PO Box 41
Alexandria, NSW 1435
Ethics committee country [2] 295301 0
Australia
Date submitted for ethics approval [2] 295301 0
08/07/2016
Approval date [2] 295301 0
Ethics approval number [2] 295301 0

Summary
Brief summary
Visually impaired older people are increasing in number and have significant ongoing morbidity including risk of falls, but are neglected in regard to falls prevention programs. We aim to evaluate the effectiveness of the Lifestyle approach to reducing Falls through Exercise (LiFE) program to prevent falls and improve function in older people with vision impairment compared to usual care, delivered through specialist Orientation and Mobility Instructors. Secondary aims are to establish the cost-effectiveness of the LiFE program compared to usual care and to identify determinants of the success of the LiFE program and implementation issues in the vision impaired population. We will conduct a randomized controlled trial evaluating the LiFE program in older people with visual impairment in NSW and ACT in collaboration with Guide Dogs NSW/ACT, a leading community service organisation for people with vision impairment.
A total of 588 participants will be recruited through Guide Dogs client database, and randomized to receive either the LiFE intervention or usual care (control group). Guide Dogs' Orientation and Mobility Instructors will receive training in delivering the LiFE program, which will be delivered to those in the intervention group. Social and demographic characteristics and visual and physical status and will be assessed at baseline, and physical status reassessed at 12 months to characterise the study cohort.. Falls will be self-reported on a monthly basis. Physical activity will be measured using actigraphy at baseline, 3 and 12 months. A sample of 30 participants in the intervention group will be interviewed after completing the program to determine how well the LiFE program concepts are integrated into daily activity.
An economic evaluation will be modeled from a health service provider perspective, with data collected on costs to deliver the LiFE program, in-patient hospital admissions, emergency department presentations and other health and community service contact, The primary outcome measures will be the rate of falls over the 12 months following randomization and the Late Life Disability and Function Index.. The secondary outcomes will be falls requiring medical care and the rate of falls per steps taken.
Trial website
Trial related presentations / publications
L Keay, L Dillon, L Clemson et al (2017); PrevenTing Falls in a high-risk, vision-impaired population through specialist ORientation and Mobility services: protocol for the PlaTFORM randomised trial. Injury Prevention, 13 February (e-pub ahead of print) doi: 10.1136/injuryprev-2016-042301
Public notes

Contacts
Principal investigator
Name 66750 0
A/Prof Lisa Keay
Address 66750 0
The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050
Country 66750 0
Australia
Phone 66750 0
+61 2 8052 4335
Fax 66750 0
Email 66750 0
lkeay@georgeinstitute.org.au
Contact person for public queries
Name 66751 0
Ms Kirsten Jakobsen
Address 66751 0
The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050
Country 66751 0
Australia
Phone 66751 0
+61 2 8052 4379
Fax 66751 0
Email 66751 0
kjakobsen@georgeinstitute.org.au
Contact person for scientific queries
Name 66752 0
A/Prof Lisa Keay
Address 66752 0
The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050
Country 66752 0
Australia
Phone 66752 0
+61296570335
Fax 66752 0
Email 66752 0
lkeay@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified individual data, collected during the trial, which has been published and pending approval from HREC.
When will data be available (start and end dates)?
Beginning 3 months after publication of final results ending 24 months after publication.
Available to whom?
Researchers with a sound methodological proposal.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Data requestors will need to sign a data sharing agreement, data will be available via secure website link. The Principal Investigator can be contacted on l.keay@unsw.edu.au
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7133 0
Study protocol
Citation [1] 7133 0
Keay L, Dillon L, Clemson L, Tiedemann A, Sherington C, McCluskey PJ, Ramulu P, Jan S, Rogers K, Martin J, Tinsley F, Jakobsen KB, Ivers RQ (2017) PrevenTing Falls in a high risk, vision impaired population through specialist ORientation and Mobility services: Protocol for the PlaTFORM randomised trial Inj Prev Feb 13. pii: injuryprev-2016-042301. doi: 10.1136/injuryprev-2016-042301.
Email [1] 7133 0
l.keay@unsw.edu.au
Other [1] 7133 0
Attachment [1] 7133 0
Type [2] 7134 0
Statistical analysis plan
Citation [2] 7134 0
Link [2] 7134 0
Email [2] 7134 0
l.keay@unsw.edu.au
Other [2] 7134 0
Attachment [2] 7134 0
Type [3] 7135 0
Informed consent form
Citation [3] 7135 0
Link [3] 7135 0
Email [3] 7135 0
l.keay@unsw.edu.au
Other [3] 7135 0
Attachment [3] 7135 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary