VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-distance Eyewear) (VISIBLE)
Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Bi-, tri- and multi- focal ('multifocal') glasses have been associated with increased rates of falls in older people (Lord et al 2002).
Study Aim: To determine whether the provision of supplementary plain distance glasses for outdoor use to older users multifocal glasses will reduce falls rates over a 12 month period.
Study Design: A randomised controlled assessor-blinded trial with two parallel groups in 580 participants. Study inclusion criteria are: outdoor use of multifocal glasses 3 or more times per week, community-dwelling persons aged 65+ years with a recent fall OR persons aged 80+ years regardless of falls history, Folstein Mini Mental score of 24+, and adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB). All participants will receive an optometry assessment and updated multifocal glasses (if required) at baseline. Intervention group subjects will receive a pair of plain distance glasses and counselling for their use in predominantly outdoor situations. Control group participants will use their multifocal glasses in their usual manner. Falls rates and compliance with the intervention will be recorded on monthly falls diaries returned by the participants.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New South Wales
-
Sydney, New South Wales, Australien, 2031
- Prince of Wales Medical Research Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- outdoor use of multifocal glasses 3 or more times per week
- community-dwelling persons aged 65+ years with a recent fall OR persons aged 80+ years regardless of falls history
- Folstein Mini Mental score of 24+
- adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB)
Exclusion Criteria:
- nursing home residents
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
|
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
|
|
Ingen indgriben: 2
Usual care, updated multifocal glasses if required
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Falls rates, Falls diaries
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Quality of life, SF-36
Tidsramme: 12 months
|
12 months
|
|
Instrumental Activities of Daily Living, Adelaide Activities Profile
Tidsramme: 12 months
|
12 months
|
|
Modified Falls Efficacy Scale
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stephen R Lord, PhD, University of New South Wales
Publikationer og nyttige links
Generelle publikationer
- Lord SR, Dayhew J, Howland A. Multifocal glasses impair edge-contrast sensitivity and depth perception and increase the risk of falls in older people. J Am Geriatr Soc. 2002 Nov;50(11):1760-6. doi: 10.1046/j.1532-5415.2002.50502.x.
- Haran MJ, Cameron ID, Ivers RQ, Simpson JM, Lee BB, Tanzer M, Porwal M, Kwan MM, Severino C, Lord SR. Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial. BMJ. 2010 May 25;340:c2265. doi: 10.1136/bmj.c2265. Erratum In: BMJ. 2016 May 27;353:i3041.
- Haran MJ, Lord SR, Cameron ID, Ivers RQ, Simpson JM, Lee BB, Porwal M, Kwan MM, Severino C. Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial. BMC Geriatr. 2009 Mar 26;9:10. doi: 10.1186/1471-2318-9-10.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 350855
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