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

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00348621
Collaborator
National Institute on Aging (NIA) (NIH)
2,544
1
2
36
70.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Visual impairment intervention program
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2544 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Trial of Interventions for Visual Loss in Nursing Home Residents
Study Start Date :
Jun 1, 1999
Actual Primary Completion Date :
Dec 1, 2001
Actual Study Completion Date :
Jun 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Visual impairment intervention program

enhanced access to eye care services

Procedure: Visual impairment intervention program
enhanced access to eye care services

No Intervention: Usual care

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

Outcome Measures

Primary Outcome Measures

  1. mobility score [1 year]

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

  2. socialization score [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Sheila West, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00348621
Other Study ID Numbers:
  • R01AG015812
  • R01AG015812
First Posted:
Jul 4, 2006
Last Update Posted:
Oct 6, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2017