NCT00347620

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

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

August 1, 2000

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

March 15, 2010

Status Verified

March 1, 2010

First QC Date

June 30, 2006

Last Update Submit

March 12, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • vision-targeted health-related quality of life

Secondary Outcomes (7)

  • depression

  • generic health-related quality of life

  • functional independence

  • participation in group activities

  • physical activities

  • +2 more secondary outcomes

Interventions

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Integrated Health Services at Briarcliff

Alabaster, Alabama, 35007, United States

Location

Shelby Ridge Nursing Home

Alabaster, Alabama, 35007, United States

Location

Livingston Health Care Center

Bessemer, Alabama, 35020, United States

Location

Southgate Village

Bessemer, Alabama, 35020, United States

Location

Beverly Healthcare Meadowood

Bessemer, Alabama, 35023, United States

Location

Fair Haven Retirement Center

Birmingham, Alabama, 35210, United States

Location

Beverly Healthcare Center Forestdale

Birmingham, Alabama, 35214, United States

Location

Beverly Healthcare East

Birmingham, Alabama, 35215, United States

Location

South Haven

Birmingham, Alabama, 35226, United States

Location

Fairview Health & Rehabilitation Center

Birmingham, Alabama, 35228, United States

Location

Estes Nursing Facility Civic Center

Birmingham, Alabama, 35234, United States

Location

Estes Nursing Facility Northway

Birmingham, Alabama, 35234, United States

Location

Beverly Healthcare Riverchase

Birmingham, Alabama, 35244, United States

Location

Beverly Health Care Center West

Fairfield, Alabama, 35964, United States

Location

The Self Nursing Home, Inc

Hueytown, Alabama, 35023, United States

Location

Beverly Healthcare Pleasant Grove

Pleasant Grove, Alabama, 35127, United States

Location

Consult America Cottage Hills

Pleasant Grove, Alabama, 35127, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Refractive ErrorsCataract

Interventions

EyeglassesCataract Extraction

Condition Hierarchy (Ancestors)

Eye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Cynthia Owsley, PhD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

August 1, 2000

Study Completion

December 1, 2003

Last Updated

March 15, 2010

Record last verified: 2010-03

Locations