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

Clinical Trial of Interventions for Visual Loss in Nursing Home Residents

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00348621
Enrollment
2544
Registered
2006-07-04
Start date
1999-06-30
Completion date
2002-06-30
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Low Vision, Refractive Error

Keywords

cataract surgery, refractive correction, low vision services, nursing home, visual impairment

Brief summary

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

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.

Interventions

PROCEDUREVisual impairment intervention program

enhanced access to eye care services

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
mobility score1 yearquestionnaire to nurses in charge of nursing home patients on specific items on mobility, which were used to create mobility score
socialization score1 yearquestionnaire to nurses in charge of nursing home patients on items specific to subject socialization, used to create socialization score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026