NCT04621292

Brief Summary

With the help of medical progress, life expectancy has increased in our country, resulting in an increase in the number of elderly people and especially so-called complex patients. These complex elderly patients present with a combination of poly pathology, locomotor disorders and loss of autonomy, which leads to increased risks of hospitalization, re-hospitalization or difficulty in remaining at home. These risks could be reduced by early adapted care specific to this type of patient. To do this, it is necessary to identify these complex elderly patients as early as possible in their care pathway. Screening complex elderly patients in the emergency department would require trained and educated staff, or the use of a simple, rapid and reliable diagnostic scale. The purpose of this study is to compare two scales for the screening of complex elderly patients, whose use is adapted to the Hospital Emergency Department environment. This study assess the diagnostic performance of the ISAR and SoCoLoc scales for complex elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 3, 2020

Last Update Submit

November 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall diagnostic performance of the two scales comparing the AUC

    The overall diagnostic performance of each scale will be measured using the area under the ROC curve (sensitivity vs. 1-specificity). The performance of the two scales will be measured and compared using a parametric or non-parametric Z-test for matched data according to the number of events observed, i.e. the number of "complex" patients. A ROC curve will be performed in order to determine the best positivity threshold of each scale. Patients will be classified as "complex" or "non-complex" by the blind adjudication committee of the results of the two scales.

    Up to emergency admission

Secondary Outcomes (3)

  • Sensitivity and specificity of the two scales

    Up to emergency admission

  • Number and proportion of complex elderly patients

    Up to emergency admission

  • Patient characteristics description

    Up to emergency admission

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will focus on patients aged 75 and over who consult the Emergency Department of the Annecy Geneva Hospital.

You may qualify if:

  • Patients over 75 years of age
  • Patient presenting to the "Emergency Department" of the Annecy Genevois hospital, whatever the reason for consultation, from Monday to Friday between 8:00 a.m. and 8:00 p.m.
  • Patient informed of the study and not opposed to participation

You may not qualify if:

  • Patients under guardianship or curatorship
  • Patients under the safeguard of justice
  • Patient presenting for a life-threatening emergency
  • Patient unable to answer the questions on the scales
  • Patient does not speak French
  • Patients who have already been included in the study: any patient already included in the study and making another trip to the emergency department cannot be included a second time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

Location

Study Officials

  • Bahman MOHEB KHOSRAVI

    CH Annecy Genevois

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

August 17, 2020

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations