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  • PrevenTing Falls in a high-risk, vision-impaired population through specialist ORientation and Mobility services: protocol for the PlaTFORM randomised trial

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Study protocol
PrevenTing Falls in a high-risk, vision-impaired population through specialist ORientation and Mobility services: protocol for the PlaTFORM randomised trial
  1. Lisa Keay1,
  2. Lisa Dillon1,2,
  3. Lindy Clemson3,
  4. Anne Tiedemann4,
  5. Catherine Sherrington4,
  6. Peter McCluskey5,
  7. Pradeep Ramulu6,
  8. Stephen Jan1,
  9. Kris Rogers1,
  10. Jodi Martin2,
  11. Frances Tinsley2,
  12. Kirsten Bonrud Jakobsen1,
  13. Rebecca Q Ivers1
  1. 1The George Institute for Global Health, University of Sydney, Sydney, Australia
  2. 2Guide Dogs NSW/ACT, Sydney, Australia
  3. 3Faculty of Health Sciences, University of Sydney, Sydney, Australia
  4. 4The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia
  5. 5Save Sight Institute, University of Sydney, Sydney, Australia
  6. 6Dana Center for Preventive Ophthalmology, Johns Hopkins University, Baltimore, USA
  1. Correspondence to Dr Lisa Keay, Deputy Director, Injury Division, The George Institute for Global Health, Associate Professor, Sydney Medical School, University of Sydney, PO Box M201, Missenden Rd NSW 2050, Australia; lkeay{at}georgeinstitute.org.au

Abstract

Background Older people with vision impairment have significant ongoing morbidity, including risk of falls, but are neglected in fall prevention programmes. PlaTFORM is a pragmatic evaluation of the Lifestyle-integrated Functional Exercise fall prevention programme for older people with vision impairment or blindness (v-LiFE). Implementation and scalability issues will also be investigated.

Methods PlaTFORM is a single-blinded, randomised trial designed to evaluate the v-LiFE programme compared with usual care. Primary outcomes are fall rate over 12 months, measured using prospective monthly fall calendars, and function and participation assessed by the Late-Life Function and Disability Instrument (Late-Life FDI) Function component. The secondary outcome is rate of falls requiring medical care. Activity-normalised fall rate will be estimated using accelerometer-measured physical activity data. EuroQol 5-dimension 5-level questionnaire will measure quality of life and impact of falls. Health record linkage will estimate resource use associated with falls. v-LiFE cost-effectiveness will be determined compared with usual care. 500 participants (250 per group) can provide 90% power to detect a significant between-group difference in fall rates; 588 will be recruited to allow for drop-out. Falls per person-year and Late-Life FDI will be compared between groups.

Discussion PlaTFORM will determine if falls can be prevented among older people with vision loss through a home-based exercise programme. v-LiFE embeds balance and strength training within everyday activities with the aim of preventing falls. The study will also determine whether the programme can be effectively delivered by personnel who provide Orientation and Mobility training for people with vision impairment.

Trial registration number ACTRN12616001186448p.

https://doi.org/10.1136/injuryprev-2016-042301

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    Footnotes

    • Contributors LK drafted this manuscript in consultation with all coauthors. All coauthors critically reviewed and approved the final version of this manuscript.

    • Funding This project is funded by the Australian National Health and Medical Research Council (NHMRC project grant APP1108176) and is supported by Guide Dogs NSW/ACT.

    • Competing interests None declared.

    • Ethics approval University of Sydney Human Research Ethics Committee (2016/787).

    • Provenance and peer review Not commissioned; internally peer reviewed.