NCT03076606

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
Last Updated

September 15, 2023

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

March 6, 2017

Last Update Submit

September 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual acuity values concordance between nurses and ophthalmologist

    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 Outcomes (2)

  • new diagnosis or ophthalmologic pathology aggravation

    day 1

  • cognitive influence

    day 1

Interventions

ophthalmologist examination after geriatric consultation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 and over referred for Visual Acuity evaluation

You may qualify if:

  • at least 2 falls in the last 12 months,
  • applied in geriatric evaluation
  • talking French
  • affiliated to the social security system

You may not qualify if:

  • not communicating
  • illiterate
  • Total blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 10, 2017

Study Start

March 20, 2017

Primary Completion

May 4, 2020

Study Completion

May 4, 2020

Last Updated

September 15, 2023

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations