Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-22 @ 12:21 PM
Study NCT ID:
NCT00347620
Status:
COMPLETED
Last Update Posted:
2010-03-15
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Vision and Quality of Life in the Nursing Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}, {'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2003-12'}, 'lastUpdateSubmitDate': '2010-03-12', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vision-targeted health-related quality of life'}], 'secondaryOutcomes': [{'measure': 'depression'}, {'measure': 'generic health-related quality of life'}, {'measure': 'functional independence'}, {'measure': 'participation in group activities'}, {'measure': 'physical activities'}, {'measure': 'falls'}, {'measure': 'life space'}]}, 'conditionsModule': {'conditions': ['Refractive Error', 'Cataract']}, 'referencesModule': {'references': [{'pmid': '17998508', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 60 years of age or older\n* expected to stay in facility foe at least 8 months\n* stable medical condition\n* moderately cognitively impaired or better\n\nExclusion Criteria:\n\n* those not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00347620', 'briefTitle': 'Improving Vision and Quality of Life in the Nursing Home', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Improving Vision and Quality of Life in the Nursing Home', 'orgStudyIdInfo': {'id': '2000-072'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spectacles', 'type': 'DEVICE'}, {'name': 'Cataract Surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35007', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Integrated Health Services at Briarcliff', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '35007', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Shelby Ridge Nursing Home', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '35020', 'city': 'Bessemer', 'state': 'Alabama', 'country': 'United States', 'facility': 'Livingston Health Care Center', 'geoPoint': {'lat': 33.40178, 'lon': -86.95444}}, {'zip': '35020', 'city': 'Bessemer', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southgate Village', 'geoPoint': {'lat': 33.40178, 'lon': -86.95444}}, {'zip': '35023', 'city': 'Bessemer', 'state': 'Alabama', 'country': 'United States', 'facility': 'Beverly Healthcare Meadowood', 'geoPoint': {'lat': 33.40178, 'lon': -86.95444}}, {'zip': '35210', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Fair Haven Retirement Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35214', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Beverly Healthcare Center Forestdale', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Beverly Healthcare East', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35226', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'South Haven', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35228', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Fairview Health & Rehabilitation Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35234', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Estes Nursing Facility Civic Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35234', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Estes Nursing Facility Northway', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Beverly Healthcare Riverchase', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35964', 'city': 'Fairfield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Beverly Health Care Center West', 'geoPoint': {'lat': 33.48594, 'lon': -86.91194}}, {'zip': '35023', 'city': 'Hueytown', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Self Nursing Home, Inc', 'geoPoint': {'lat': 33.45122, 'lon': -86.99666}}, {'zip': '35127', 'city': 'Pleasant Grove', 'state': 'Alabama', 'country': 'United States', 'facility': 'Beverly Healthcare Pleasant Grove', 'geoPoint': {'lat': 33.49094, 'lon': -86.97027}}, {'zip': '35127', 'city': 'Pleasant Grove', 'state': 'Alabama', 'country': 'United States', 'facility': 'Consult America Cottage Hills', 'geoPoint': {'lat': 33.49094, 'lon': -86.97027}}], 'overallOfficials': [{'name': 'Cynthia Owsley, PhD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Retirement Research Foundation', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'Research to Prevent Blindness', 'class': 'OTHER'}, {'name': 'EyeSight Foundation of Alabama', 'class': 'OTHER'}, {'name': 'Pearle Vision Foundation', 'class': 'UNKNOWN'}]}}}