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| Tracking Information | |||||
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| 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 |
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| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | December 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | June 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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