NCT04683380

Brief Summary

After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

December 16, 2020

Last Update Submit

January 5, 2022

Conditions

Keywords

Elderly dependenceEmergency room visitsLack of autonomyRobustnessRe-hospitalization

Outcome Measures

Primary Outcomes (10)

  • Identification of predictive factors of robustness : Autonomy level at home (ADL score)

    ADL self-performance coding ranges from 0 (independent) to 4 (total dependence).

    3 months

  • Identification of predictive factors of robustness by a questionnaire (help at home)

    Need of help at home such as : toilet, breakfast, lunch, dinner (yes or not)

    3 months

  • Identification of predictive factors of robustness by a questionnaire (family visits)

    Number of family visits

    3 months

  • Identification of predictive factors of robustness by a questionnaire (appetit)

    loss of appetite (yes or not)

    3 months

  • Identification of predictive factors of robustness (heart rate)

    Heart rate during hospitalization (minimum and maximum values)

    3 months

  • Identification of predictive factors of robustness (Modified Triage Risk Screening Tool (TRST)) score

    The TRST score is a tool to predict repeat emergency department visits and hospitalizations in older patients discharged from the emergency department; This tool evaluates 5 dimensions : cognitive disorders presence, walking disorders, polymedication, hospitalization antecedents and functional assessment (loss of autonomy). Every dimension is worth 1 point if the patient presents the disorder. The final maximum score is 5 points.

    3 months

  • Identification of predictive factors of robustness : BMI (Body Mass Index)

    Body mass index

    3 months

  • Albuminemia

    Rate of Albuminemia

    3 months

  • Identification of predictive factors of robustness : Lifestyle

    Lifestyle: person living alone (yes or not)

    3 months

  • Sleep assessment using a Visual Analog Scale (VAS).

    This scale allows patients to assess their fatigue. The patients locate their fatigue intensity on a 100-millimeters horizontal line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    3 months

Secondary Outcomes (3)

  • Rate of re-hospitalization

    3 months

  • Rate of patient survival

    3 months

  • Rate of lack of Institutionalization

    3 months

Eligibility Criteria

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

The study population is composed of patients aged more than 75 years old and who have eligibility criteria.

You may qualify if:

  • Patients admitted to the emergency room
  • Patients aged ≥ 75 years old
  • Patients without cognitive disorders or vigilance disorders
  • Patients living at home
  • Patients able to give its non-opposition
  • Patients admitted to the hospital in the last 3 months
  • Patients refusing to participate in the study

You may not qualify if:

  • Patients whose stay is \< 14h or \> 48h
  • Patients who die during hospitalization
  • Patient not hospitalized
  • Patient not returning home after discharge from hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Vincent Hospital

Lille, Haut-de-France, 59000, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Bouquillon

    Hôpital Saint-Vincent de Paul

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 24, 2020

Study Start

March 10, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

January 6, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations