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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348621
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE July 3, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date October 6, 2017
Study Start Date  ICMJE June 1999
Actual Primary Completion Date December 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • mobility score [ Time Frame: 1 year ]
    questionnaire to nurses in charge of nursing home patients on specific items on mobility, which were used to create mobility score
  • socialization score [ Time Frame: 1 year ]
    questionnaire to nurses in charge of nursing home patients on items specific to subject socialization, used to create socialization score
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2006)
  • mobility score
  • socialization score
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2006)
Use of psychoactive medications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Interventions to Reduce Disability From Visual Loss in Nursing Home Residents
Official Title  ICMJE Clinical Trial of Interventions for Visual Loss in Nursing Home Residents
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Refractive Error
  • Low Vision
Intervention  ICMJE Procedure: Visual impairment intervention program
enhanced access to eye care services
Study Arms  ICMJE
  • Active Comparator: Visual impairment intervention program
    enhanced access to eye care services
    Intervention: Procedure: Visual impairment intervention program
  • No Intervention: Usual care
    family and nursing home was apprised of ocular exam results; eye care services left to family/nursing home arrangements
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
2544
Original Enrollment  ICMJE
 (submitted: July 3, 2006)
1600
Actual Study Completion Date  ICMJE June 2002
Actual Primary Completion Date December 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00348621
Other Study ID Numbers  ICMJE R01AG015812( U.S. NIH Grant/Contract )
R01AG015812 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Sheila West Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP