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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Ruth Ma van Nispen; Gianni Virgili; Mirke Hoeben; Maaike Langelaan; Jeroen Klevering; Jan Ee Keunen; Ger Hmb van Rens Journal: Cochrane Database Syst Rev Date: 2020-01-27