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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

9/07/2021

Date data sharing statement 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]

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

Fear of falling

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Eye

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]

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]

Number of falls over 12 months following randomisation, based on prospective, self-reporting by monthly falls calendars.

Timepoint [1]

Falls will be recorded prospectively for 12 months using monthly calendars with active follow-up,

Primary outcome [2]

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]

12 months after randomisation

Secondary outcome [1]

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]

Falls will be recorded prospectively for 12 months using monthly calendars with active follow-up,

Secondary outcome [2]

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]

12 months after randomisation

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Not Applicable

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

Completed

Date of first participant enrolment

Anticipated

20/02/2017

Actual

1/03/2017

Date of last participant enrolment

Anticipated

31/08/2018

Actual

22/01/2019

Date of last data collection

Anticipated

22/03/2020

Actual

23/03/2020

Sample size

Target

588

Accrual to date

Final

588

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1, 16 Marcus Clarke Street
Canberra, ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 6, Jane Foss Russell Building 
University of Sydney, NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/07/2016

Approval date [1]

20/10/2016

Ethics approval number [1]

Ethics committee name [2]

NSW Population and Health Services Research Ethics Committee

Ethics committee address [2]

PO Box 41 
Alexandria, NSW 1435

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

08/07/2016

Approval date [2]

Ethics approval number [2]

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

A/Prof Lisa Keay

Address

The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050

Country

Australia

Phone

+61 2 8052 4335

Fax

lkeay@georgeinstitute.org.au

Contact person for public queries

Name

Kirsten Jakobsen

Address

The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050

Country

Australia

Phone

+61 2 8052 4379

Fax

kjakobsen@georgeinstitute.org.au

Contact person for scientific queries

Name

Lisa Keay

Address

The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050

Country

Australia

Phone

+61296570335

Fax

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?

Doc. No.	Type	Citation	Link	Email
7133	Study protocol	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.	https://injuryprevention.bmj.com/content/24/6/459.long	l.keay@unsw.edu.au
7134	Statistical analysis plan			l.keay@unsw.edu.au
7135	Informed consent form			l.keay@unsw.edu.au

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	PrevenTing Falls in a high-risk, vision-impaired population through specialist ORientation and Mobility services: protocol for the PlaTFORM randomised trial.	2018	https://dx.doi.org/10.1136/injuryprev-2016-042301
Embase	Recipient and instructor perspectives of an adapted exercise-based fall prevention programme for adults aged 50+ years with vision impairment: a qualitative study nested within a randomised controlled trial.	2020	https://dx.doi.org/10.1136/bmjopen-2020-038386

N.B. These documents automatically identified may not have been verified by the study sponsor.

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