Overview

This trial is active, not recruiting.

Conditions cataract, refractive error, low vision
Treatment visual impairment interventions
Phase phase 4
Sponsor Johns Hopkins University
Collaborator National Institutes of Health (NIH)
Start date June 1999
End date June 2002
Trial size 1600 participants
Trial identifier NCT00348621, RO1AG15812

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.We 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
mobility score
time frame:
socialization score
time frame:

Secondary Outcomes

Measure
Use of psychoactive medications
time frame:

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Clinical Trial of Interventions for Visual Loss in Nursing Home Residents
Principal investigator Sheila West
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, we 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, we 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. We 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. We 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2006.
Information provided to ClinicalTrials.gov by Johns Hopkins University.