Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348621
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2006-07-03
Brief Title:
A Study of Interventions to Reduce Disability From Visual Loss in Nursing Home Residents
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Clinical Trial of Interventions for Visual Loss in Nursing Home Residents
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lettersymbol 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG015812 | NIH | None | httpsreporternihgovquickSearchR01AG015812 |