- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076606
Nurses Ability to Assess Visual Acuity in Geriatric Consultation (AVIGE)
Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.
The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.
We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.
This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14033
- Caen University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- at least 2 falls in the last 12 months,
- applied in geriatric evaluation
- talking French
- affiliated to the social security system
Exclusion Criteria:
- not communicating
- illiterate
- Total blindness
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual acuity values concordance between nurses and ophthalmologist
Time Frame: day 1
|
On 2 (near and far) binocular values per patient with their usual glasses.
Concordance is assessed on the assignment of patients to one of the 3 groups: ≤ 5 / 10e, 6-7 / 10 e, ≥ 8/10 e
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
new diagnosis or ophthalmologic pathology aggravation
Time Frame: day 1
|
Percentage of patients in whom new diagnosis or ophthalmologic pathology aggravation was identified
|
day 1
|
cognitive influence
Time Frame: day 1
|
Compare the binocular visual acuity values agreement in each subgroup: with MMSE <18/30 and with MMSE ≥18/30
|
day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AVIGE 16-114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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