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

Primary Purpose

Cataract, Refractive Error, Low Vision

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Visual impairment intervention program
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract surgery, refractive correction, low vision services, nursing home, visual impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Visual impairment intervention program

Usual care

Arm Description

enhanced access to eye care services

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 3, 2006
Last Updated
October 4, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00348621
Brief Title
A Study of Interventions to Reduce Disability From Visual Loss in Nursing Home Residents
Official Title
Clinical Trial of Interventions for Visual Loss in Nursing Home Residents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Refractive Error, Low Vision
Keywords
cataract surgery, refractive correction, low vision services, nursing home, visual impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visual impairment intervention program
Arm Type
Active Comparator
Arm Description
enhanced access to eye care services
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
family and nursing home was apprised of ocular exam results; eye care services left to family/nursing home arrangements
Intervention Type
Procedure
Intervention Name(s)
Visual impairment intervention program
Intervention Description
enhanced access to eye care services
Primary Outcome Measure Information:
Title
mobility score
Description
questionnaire to nurses in charge of nursing home patients on specific items on mobility, which were used to create mobility score
Time Frame
1 year
Title
socialization score
Description
questionnaire to nurses in charge of nursing home patients on items specific to subject socialization, used to create socialization score
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila West
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12147587
Citation
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.
Results Reference
background
PubMed Identifier
12815493
Citation
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.
Results Reference
background
PubMed Identifier
15249367
Citation
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.
Results Reference
background
PubMed Identifier
16286622
Citation
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.
Results Reference
result

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

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