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Improving Vision and Quality of Life in the Nursing Home

Primary Purpose

Refractive Error, Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
spectacles
Cataract Surgery
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Integrated Health Services at Briarcliff
  • Shelby Ridge Nursing Home
  • Livingston Health Care Center
  • Southgate Village
  • Beverly Healthcare Meadowood
  • Fair Haven Retirement Center
  • Beverly Healthcare Center Forestdale
  • Beverly Healthcare East
  • South Haven
  • Fairview Health & Rehabilitation Center
  • Estes Nursing Facility Civic Center
  • Estes Nursing Facility Northway
  • Beverly Healthcare Riverchase
  • Beverly Health Care Center West
  • The Self Nursing Home, Inc
  • Beverly Healthcare Pleasant Grove
  • Consult America Cottage Hills

Outcomes

Primary Outcome Measures

vision-targeted health-related quality of life

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2006
Last Updated
March 12, 2010
Sponsor
University of Alabama at Birmingham
Collaborators
Retirement Research Foundation, National Institute on Aging (NIA), National Eye Institute (NEI), Research to Prevent Blindness, EyeSight Foundation of Alabama, Pearle Vision Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00347620
Brief Title
Improving Vision and Quality of Life in the Nursing Home
Official Title
Improving Vision and Quality of Life in the Nursing Home
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Retirement Research Foundation, National Institute on Aging (NIA), National Eye Institute (NEI), Research to Prevent Blindness, EyeSight Foundation of Alabama, Pearle Vision Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
spectacles
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Primary Outcome Measure Information:
Title
vision-targeted health-related quality of life
Secondary Outcome Measure Information:
Title
depression
Title
generic health-related quality of life
Title
functional independence
Title
participation in group activities
Title
physical activities
Title
falls
Title
life space

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Owsley, PhD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Health Services at Briarcliff
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Facility Name
Shelby Ridge Nursing Home
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Facility Name
Livingston Health Care Center
City
Bessemer
State/Province
Alabama
ZIP/Postal Code
35020
Country
United States
Facility Name
Southgate Village
City
Bessemer
State/Province
Alabama
ZIP/Postal Code
35020
Country
United States
Facility Name
Beverly Healthcare Meadowood
City
Bessemer
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Fair Haven Retirement Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35210
Country
United States
Facility Name
Beverly Healthcare Center Forestdale
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35214
Country
United States
Facility Name
Beverly Healthcare East
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
South Haven
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Fairview Health & Rehabilitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35228
Country
United States
Facility Name
Estes Nursing Facility Civic Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Estes Nursing Facility Northway
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Beverly Healthcare Riverchase
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Beverly Health Care Center West
City
Fairfield
State/Province
Alabama
ZIP/Postal Code
35964
Country
United States
Facility Name
The Self Nursing Home, Inc
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Beverly Healthcare Pleasant Grove
City
Pleasant Grove
State/Province
Alabama
ZIP/Postal Code
35127
Country
United States
Facility Name
Consult America Cottage Hills
City
Pleasant Grove
State/Province
Alabama
ZIP/Postal Code
35127
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17998508
Citation
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. doi: 10.1001/archopht.125.11.1471.
Results Reference
derived

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Improving Vision and Quality of Life in the Nursing Home

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