Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group

NCT04470895 | Withdrawn

• 1 other identifier: MEDI-CHUTE
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Falls of the elderly are a public health problem that have been neglected for too long. The experience of a fall makes the elderly person vulnerable, even in the absence of traumatic consequences, and can sometimes be a reason for institutionalization. These falls are frequent and have many repercussions on the autonomy of seniors. According to data from the National Institute for Prevention and Health Education (INPES), falls are the leading cause of accidental death among people over 65 years of age. They cause approximately 8,500 deaths per year. After the age of 65, one person in three falls at least once a year. They account for 10% of the reasons for consultation and 12% of hospitalizations in geriatric settings among the elderly. The risk increases with age because 80% of people over 85 years of age fall at least once a year. 20 to 30% of people over 65 have a loss or decrease in autonomy after a fall. The risk of another fall is twenty times higher after a first fall and the risk of death increases especially in the year following the fall. This is of major importance because falls are responsible for the majority of fractures in the elderly, especially femoral neck fractures. The cost of falls among the elderly is significant and estimated at 2 billion euros for communities.

Conditions

Fracture; Fall

Keywords

elderly; ageing

Outcome Measures

Primary Outcomes (1)

• Impact of drugs on Fracture Track Patients

  The research aims at determining the impact of drug intake (number and type of drugs) on the occurrence of falls in patients hospitalized for an osteoporotic fracture.

  July, 2020

Secondary Outcomes (1)

• Frequency of falls on Fracture Track patients.

  July, 2020

Study Arms (2)

Usual falling patients

a group enrolling the patients who completed the inclusive criteria and have had at least one fall in the last 12 months in addition to the possible fall causing the index fracture. These patients must answer positively the following question "Have you fallen in the last 12 months, regardless of the current fracture"?

Diagnostic Test: Failure Track patients analysis

Unusual falling patients

a group enrolling the patients who also completed the inclusive criteria, but are defined as "unsual falling patients". These patients must answer negatively the following question: "Have you fallen in the last 12 months, regardless of the current fracture"?

Diagnostic Test: Failure Track patients analysis

Interventions

Failure Track patients analysis DIAGNOSTIC_TEST

The nurse coordinator of the Fracture Track first comes to give the patient a written information note. She answers the patient's questions and obtains his or her non-opposition. The patient must be given sufficient time for reflection to make his decision in order to participate in the study. His non opposition will be traced in the computerized medical record. Each enrolling patient in the study can simultaneously participate in another research. There is no exclusion period in the protocol. Once the patient is included, a semi-directed interview is conducted. The name of the patient's usual pharmacy will be collected. Data from the computerised medical record concerning the patient's stay are also analysed. The patient's usual pharmacy or the nurse in charge of the patient will then be questioned in order to carry out a drug reconciliation interview.

Unusual falling patients; Usual falling patients

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study involving patients aged between 45 and 95 years, who is affiliated to the fracture track and has taken various types of medications after a fall that has occurred in the last 12 months

You may qualify if:

• Patient aged between 45 and 95
• French-speaking
• Patient included in the GhPSJ fracture track, taking at least one long-term prescription medication and hospitalized in a GhPSJ department or in Léopold Bellan.

You may not qualify if:

• Patient objecting to participation in the study
• Patient who has recently moved or medical nomadism making it impossible to reconcile medication with a pharmacy
• Patient not hospitalized or transferred to a hospital other than the GhPSJ or Léopold Bellan at the time of the fracture
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under the safeguard of justice.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Related Links

• Chute sur la personne âgée: causes, conséquences et prévention
• Médicaments et chutes \[Internet\]

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 14, 2020
• Study Start: September 24, 2021
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01