Improving Vision and Quality of Life in the Nursing Home - Tabular View

Tracking Information

First Received Date ^ICMJE

June 30, 2006

Last Updated Date

June 30, 2006

Start Date ^ICMJE

August 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

vision-targeted health-related quality of life

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

depression
generic health-related quality of life
functional independence
participation in group activities
physical activities
falls
life space

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Improving Vision and Quality of Life in the Nursing Home

Official Title ^ICMJE

Improving Vision and Quality of Life in the Nursing Home

Brief Summary

The primary purpose of this study is to evaluate whether interventions to improve vision in nursing home residents have an impact on residents' health-related quality of life. The interventions being evaluated are correction of refractive error (near-sightedness, far-sightedness, presbyopia) and cataract surgery.

Detailed Description

The purpose of this project is two-fold: 1.) to establish the psychometric properties of the Nursing Home Vision-Specific Health-Related Quality of Life (HRQOL) instrument, and; 2.) to evaluate the responsiveness of this instrument. Responsiveness will be assessed in two independent preliminary prospective intervention evaluations. The first responsiveness evaluation will involve a new spectacle intervention and the second will involve first eye cataract surgery. In addition, we will examine the association between the responsiveness of this instrument, and changes in visual functioning measures and other demographic variables.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Refractive Error
Cataract

Intervention ^ICMJE

Device: spectacles
Procedure: Cataract Surgery

Study Arms / Comparison Groups

Publications *

Owsley C, McGwin G Jr, Scilley K, Meek GC, Seker D, Dyer A. Effect of refractive error correction on health-related quality of life and depression in older nursing home residents. Arch Ophthalmol. 2007 Nov;125(11):1471-7.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

at least 60 years of age or older
expected to stay in facility foe at least 8 months
stable medical condition
moderately cognitively impaired or better

Exclusion Criteria:

those not meeting inclusion criteria

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00347620

Responsible Party

Study ID Numbers ^ICMJE

2000-072

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Retirement Research Foundation
National Institute on Aging (NIA)
National Eye Institute (NEI)
Research to Prevent Blindness
EyeSight Foundation of Alabama
Pearle Vision Foundation

Investigators ^ICMJE

Principal Investigator:

Cynthia Owsley, PhD, MSPH

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP