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

Study Overview
=================
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.

Official Title
-----------------
Clinical Trial of Interventions for Visual Loss in Nursing Home Residents

Conditions
-----------------
Cataract, Refractive Error, Low Vision

Intervention / Treatment
-----------------
* Procedure: Visual impairment intervention program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Visual impairment intervention program<br>enhanced access to eye care services | Procedure: Visual impairment intervention program<br>* enhanced access to eye care services<br>|
| No Intervention: Usual care<br>family and nursing home was apprised of ocular exam results; eye care services left to family/nursing home arrangements | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mobility score | questionnaire to nurses in charge of nursing home patients on specific items on mobility, which were used to create mobility score | 1 year | 
| socialization score | questionnaire to nurses in charge of nursing home patients on items specific to subject socialization, used to create socialization score | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, refractive correction, low vision services, nursing home, visual impairment