NCT04787146

Brief Summary

The damage caused by patient falls is a major public health problem, due to the large and growing number of people concerned, the potentially serious consequences but also the financial cost generated by their care. These consequences can be physical as well as psychological. Fractures and pain are the first consequences that come to mind, but many others should be mentioned: post-fall syndrome, loss of autonomy or even entering an institution, fear of falling, loss of confidence in itself.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

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

Study Start

First participant enrolled

April 18, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 1, 2021

Last Update Submit

March 5, 2021

Conditions

Keywords

Drugs

Outcome Measures

Primary Outcomes (1)

  • To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group.

    Percentage of falls involving one or more drugs at risk of falling

    1 week

Secondary Outcomes (3)

  • List the drug treatments at risk taken by patients who fall

    1 week

  • Evaluate the relevance of drug prescriptions in patients who fall

    1 week

  • Evaluate the overall compliance of falling patients

    1 week

Study Arms (1)

Patients

From Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day). After delivery of the written information note to the patient, the investigating physician answers the patient's questions and accepts his non-objection. The patient should be given sufficient time to think things through to make the decision to participate in the study. Its non-opposition will be traced in the computerized medical file created on the day of its inclusion in the protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol.

Other: No intervention

Interventions

Once the patient is included, a drug assessment is carried out as part of the treatment and then an compliance questionnaire is submitted to him.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day).

You may qualify if:

  • Major patient
  • French-speaking patient
  • Patient hospitalized within the Paris Saint-Joseph Hospital Group
  • Patient who fell during hospitalization and for whom a fall report has been completed

You may not qualify if:

  • Patients in the process of therapeutic limitation
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient objecting to participation in the study
  • Patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Elodie MENAGE

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 8, 2021

Study Start

April 18, 2019

Primary Completion

October 15, 2019

Study Completion

February 28, 2021

Last Updated

March 8, 2021

Record last verified: 2021-03

Locations