NCT00350389

Brief Summary

The purpose of this study is 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.2 years

First QC Date

July 6, 2006

Last Update Submit

June 1, 2015

Conditions

Falls

Keywords

Falls, Older persons

Outcome Measures

Primary Outcomes (1)

  • Falls rates, Falls diaries

    12 months

Secondary Outcomes (3)

  • Quality of life, SF-36

    12 months

  • Instrumental Activities of Daily Living, Adelaide Activities Profile

    12 months

  • Modified Falls Efficacy Scale

    12 months

Study Arms (2)

1

EXPERIMENTAL

Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

Behavioral: Outdoor use of plain distance glasses with counselling

2

NO INTERVENTION

Usual care, updated multifocal glasses if required

Interventions

Outdoor use of plain distance glasses with counsellingBEHAVIORAL

Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • nursing home residents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Medical Research Institute

Sydney, New South Wales, 2031, Australia

Location

Related Publications (4)

  • 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.

    PMID: 12410892BACKGROUND

  • Clemson L, Stark S, Pighills AC, Fairhall NJ, Lamb SE, Ali J, Sherrington C. Environmental interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2023 Mar 10;3(3):CD013258. doi: 10.1002/14651858.CD013258.pub2.

    PMID: 36893804DERIVED

  • 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.

    PMID: 20501583DERIVED

  • 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.

    PMID: 19321012DERIVED

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephen R Lord, PhD

    University of New South Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Principal Research Fellow

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

June 1, 2005

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

AU(1)