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NCT00347620 Clinical Trial

Improving Vision and Quality of Life in the Nursing Home

Cataract Clinical Trial

Official title:
Improving Vision and Quality of Life in the Nursing Home

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00347620
Other study ID # 2000-072
Secondary ID
Status Completed
Phase N/A
First received June 30, 2006
Last updated March 12, 2010
Start date August 2000
Est. completion date December 2003

Study information
Verified date March 2010
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• spectacles

Procedure:
• Cataract Surgery

Locations
Country Name City State
United States Integrated Health Services at Briarcliff Alabaster Alabama
United States Shelby Ridge Nursing Home Alabaster Alabama
United States Beverly Healthcare Meadowood Bessemer Alabama
United States Livingston Health Care Center Bessemer Alabama
United States Southgate Village Bessemer Alabama
United States Beverly Healthcare Center Forestdale Birmingham Alabama
United States Beverly Healthcare East Birmingham Alabama
United States Beverly Healthcare Riverchase Birmingham Alabama
United States Estes Nursing Facility Civic Center Birmingham Alabama
United States Estes Nursing Facility Northway Birmingham Alabama
United States Fair Haven Retirement Center Birmingham Alabama
United States Fairview Health & Rehabilitation Center Birmingham Alabama
United States South Haven Birmingham Alabama
United States Beverly Health Care Center West Fairfield Alabama
United States The Self Nursing Home, Inc Hueytown Alabama
United States Beverly Healthcare Pleasant Grove Pleasant Grove Alabama
United States Consult America Cottage Hills Pleasant Grove Alabama

Sponsors (7)
Lead Sponsor Collaborator
University of Alabama at Birmingham EyeSight Foundation of Alabama, National Eye Institute (NEI), National Institute on Aging (NIA), Pearle Vision Foundation, Research to Prevent Blindness, Retirement Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary vision-targeted health-related quality of life
Secondary depression
Secondary generic health-related quality of life
Secondary functional independence
Secondary participation in group activities
Secondary physical activities
Secondary falls
Secondary life space
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