A Study of Interventions to Reduce Disability From Visual Loss in Nursing Home Residents
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ClinicalTrials.gov Identifier: NCT00348621 |
Recruitment Status :
Completed
First Posted : July 4, 2006
Last Update Posted : October 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cataract Refractive Error Low Vision | Procedure: Visual impairment intervention program | Phase 4 |
The goal of this project was to quantify the impact of visual acuity impairment on socialization and physical function of nursing home residents, and to determine the cost effectiveness of a visual impairment intervention program designed to enhance access to eye care services. To accomplish these aims, the investigators enrolled a complete sample of visually impaired persons from 28 nursing homes in the Lower Eastern Shore of Maryland and Delaware. From the same facilities, the investigators also enrolled a random sample of non-visually impaired residents, with sample size equal to the sample of visually impaired. The group of visually impaired residents was randomized (by facility) to an intervention program or "usual care" group. The intervention program facilitated the utilization of eye care services of the three main causes of visual impairment: refractive error, cataract, and low vision associated with age-related eye diseases. All study groups provided data at baseline, six and twelve months from intervention, and data on eye care utilization, hospitalizations, use of psychoactive medications and mortality collected every other month (bi-monthly). Patients had a screening test of visual acuity, using standard letter/symbol charts, and grating charts. The mental status was tested using the MiniMental State Examination. Social function, physical function, and mobility were assessed through questionnaires asked of nursing home staff familiar with the patient, and the questions were modeled on the Minimum Data Set questions or specially designed for nursing home residents.
The investigators compare the mobility scores, and socialization scores, of nursing home residents with visual loss randomized to the intervention homes to the scores of nursing home residents with visual loss randomized to control homes. The investigators use the mobility and socialization scores of those without visual loss at baseline and follow up to compare with the trajectory of decline in those with visual loss.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2544 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial of Interventions for Visual Loss in Nursing Home Residents |
Study Start Date : | June 1999 |
Actual Primary Completion Date : | December 2001 |
Actual Study Completion Date : | June 2002 |

Arm | Intervention/treatment |
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Active Comparator: Visual impairment intervention program
enhanced access to eye care services
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Procedure: Visual impairment intervention program
enhanced access to eye care services |
No Intervention: Usual care
family and nursing home was apprised of ocular exam results; eye care services left to family/nursing home arrangements
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- mobility score [ Time Frame: 1 year ]questionnaire to nurses in charge of nursing home patients on specific items on mobility, which were used to create mobility score
- socialization score [ Time Frame: 1 year ]questionnaire to nurses in charge of nursing home patients on items specific to subject socialization, used to create socialization score

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nursing homes in Eastern Shore of Maryland,within 1.5 hour drive of Salisbury MD
- Nursing home administrators and resident committees approved the study
- Nursing home residents:
- Age 65 and older
- more than 30 day length of Stay
- Capable of acuity testing
Exclusion Criteria:
- Nursing home residents:
- staff assessment noted imminent death likely (within 3 months)
- resident unable to provide informed consent and guardian not locatable
- resident's only language was not understood by nursing staff

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348621
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Sheila West | Johns Hopkins University |
Other Publications:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00348621 |
Other Study ID Numbers: |
R01AG015812 ( U.S. NIH Grant/Contract ) R01AG015812 ( U.S. NIH Grant/Contract ) |
First Posted: | July 4, 2006 Key Record Dates |
Last Update Posted: | October 6, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
cataract surgery refractive correction low vision services nursing home visual impairment |
Vision, Low Cataract Refractive Errors Lens Diseases Eye Diseases |
Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases |