NCT00348621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,544

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 1999

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.5 years

First QC Date

July 3, 2006

Last Update Submit

October 4, 2017

Conditions

CataractRefractive ErrorLow Vision

Keywords

cataract surgeryrefractive correctionlow vision servicesnursing homevisual impairment

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Visual impairment intervention program

ACTIVE COMPARATOR

enhanced access to eye care services

Procedure: Visual impairment intervention program

Usual care

NO INTERVENTION

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

Interventions

Visual impairment intervention programPROCEDURE

enhanced access to eye care services

Visual impairment intervention program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

  • 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.

    PMID: 12147587BACKGROUND

  • 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.

    PMID: 12815493BACKGROUND

  • 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.

    PMID: 15249367BACKGROUND

  • 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.

    PMID: 16286622RESULT

MeSH Terms

Conditions

CataractRefractive ErrorsVision, LowVision Disorders

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sheila West

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

June 1, 1999

Primary Completion

December 1, 2001

Study Completion

June 1, 2002

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)