A Study of Interventions to Reduce Disability From Visual Loss in Nursing Home Residents

NCT ID: NCT00348621

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2544 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2002-06-30

Brief Summary

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The purpose of this clinical trial is to determine if interventions within the nursing home to restore vision, or cope with visual loss, in residents with visual impairment result in improvement or less decline in mobility scores, and socialization scores, compared to residents with visual impairment in nursing homes with no such intervention. The investigators hypothesized that nursing home residents with visual loss who receive cataract surgery, or refractive correction, or low vision aids would have have better socialization scores and mobility scores at 6 months and 12 months compared to nursing home residents with visual impairment who are advised to seek services, but have no specific program.

Detailed Description

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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.

Conditions

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Cataract Refractive Error Low Vision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Visual impairment intervention program

enhanced access to eye care services

Group Type ACTIVE_COMPARATOR

Visual impairment intervention program

Intervention Type PROCEDURE

enhanced access to eye care services

Usual care

family and nursing home was apprised of ocular exam results; eye care services left to family/nursing home arrangements

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Visual impairment intervention program

enhanced access to eye care services

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheila West

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Friedman DS, Munoz B, Massof RW, Bandeen-Roche K, West SK. Grating visual acuity using the preferential-looking method in elderly nursing home residents. Invest Ophthalmol Vis Sci. 2002 Aug;43(8):2572-8.

Reference Type BACKGROUND
PMID: 12147587 (View on PubMed)

West SK, Friedman D, Munoz B, Roche KB, Park W, Deremeik J, Massof R, Frick KD, Broman A, McGill W, Gilbert D, German P. A randomized trial of visual impairment interventions for nursing home residents: study design, baseline characteristics and visual loss. Ophthalmic Epidemiol. 2003 Jul;10(3):193-209. doi: 10.1076/opep.10.3.193.15081.

Reference Type BACKGROUND
PMID: 12815493 (View on PubMed)

Friedman DS, West SK, Munoz B, Park W, Deremeik J, Massof R, Frick K, Broman A, McGill W, Gilbert D, German P. Racial variations in causes of vision loss in nursing homes: The Salisbury Eye Evaluation in Nursing Home Groups (SEEING) Study. Arch Ophthalmol. 2004 Jul;122(7):1019-24. doi: 10.1001/archopht.122.7.1019.

Reference Type BACKGROUND
PMID: 15249367 (View on PubMed)

Friedman DS, Munoz B, Roche KB, Massof R, Broman A, West SK. Poor uptake of cataract surgery in nursing home residents: the Salisbury Eye Evaluation in Nursing Home Groups study. Arch Ophthalmol. 2005 Nov;123(11):1581-7. doi: 10.1001/archopht.123.11.1581.

Reference Type RESULT
PMID: 16286622 (View on PubMed)

Other Identifiers

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R01AG015812

Identifier Type: NIH

Identifier Source: secondary_id

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R01AG015812

Identifier Type: NIH

Identifier Source: org_study_id

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