Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home

NCT ID: NCT04132544

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

952 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2024-04-30

Brief Summary

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In this project, the investigators are interested in a particular population, that of elderly subjects who used the SAMU after a fall and who are not hospitalized or are hospitalized less than 24 hours. The scientific literature concerning this population is poor . However, this is a particularly vulnerable population. The Direction of research, studies, evaluation and statistics (DREES) report notes that in 2005 in metropolitan France, 24% of people aged 65 to 75 said they had fallen in the last 12 months. Home falls among seniors may require emergency medical services (EMS).

Detailed Description

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The first cause of accidental death in people over 65, the fall often has a pejorative impact on the physical, psychological and quality of life . It is also predictive of entry into an institution.

In this project, the investigators propose to evaluate the patient at home with a Gerontological Assessment Nurse working in collaboration with the attending physician, whenever the fall triggers a call to the SAMU (without hospitalization or with hospitalization of less than 24 hours). In addition to the evaluation, the nurse will propose a personalized intervention plan (PIP) based on targeted and prioritized actions.

The Main objective is to study the effect of a personalized intervention plan (PIP) proposed by a Gerontological Assessment Nurse at home in the elderly who used the SAMU for a fall (with on-site care or hospitalization inferior to 24h), on the delay institutionalization or death before institutionalization compared to standard care.

Conditions

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Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional multicenter and open, randomized study in parallel groups comparing two arms
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention group

* a standardized gerontological evaluation (EGS) and a fall balance performed at home by a Gerontological Assessment Nurse
* the proposal for a Proposal for a personalized intervention plan (PIP) to correct potentially reversible and modifiable factors
* a close follow-up by the Gerontological Assessment Nurse for the implementation of the PIP throughout the follow-up period of 24 months (6 home visits and 5 telephone follow-ups).

Group Type EXPERIMENTAL

standardized gerontological evaluation (EGS)

Intervention Type OTHER

Evaluation (EGS): initially, the patient benefits from a complete EGS and a complete fall balance realized by a Gerontological Assessment Nurse (initial visit V0) in the 7 working days following the intervention of the SAMU for fall. This assessment is based on the EGS and the assessment of risk factors for falls (HAS, INPES).

Proposal for a personalized intervention plan (PIP)

Intervention Type OTHER

A PIP containing personalized recommendations to improve the patient's state of health, treatment and environment as well as risk factors for falls is proposed during the multi-professional consultation and discussed by telephone with the attending physician (pre-arranged telephone appointment). with the latter).

The PIP validated by the attending physician is delivered and explained to the patient by the Gerontological Assessment Nurse in the week following the Multidisciplinary Team Meeting (MDTM) during the V1 visit to the patient's home.

Follow-up

Intervention Type OTHER

Four follow-up visits at 6, 12, 18 and 24 months (V2, V3, V4, V5) are performed at the patient's home. During these visits, the Gerontological Assessment Nurse reassesses the person from the gerontological point of view and from the point of view of risk factors for falls.

A mail containing the elements of interest is sent to the attending physician after each visit. The patient is also contacted by telephone by the Gerontological Assessment Nurse at 2, 4, 9, 15 and 21 months of follow-up to maintain a link, identify possible difficulties and encourage him / her to apply the PIP recommendations.

Comparison group - usual care

Usual Care with the provision of documentation on simple recommendations for the prevention of falls and aging well.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

The patients included in the "control" group will benefit from the usual care as well as documentation on general recommendations to be put in place to prevent falls and to age in good health \[series of brochures published by INPES for the elderly. They are informed by telephone of their home group by the Gerontological Assessment Nurse. The documents are sent by mail to the patient's home address.

Interventions

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standardized gerontological evaluation (EGS)

Evaluation (EGS): initially, the patient benefits from a complete EGS and a complete fall balance realized by a Gerontological Assessment Nurse (initial visit V0) in the 7 working days following the intervention of the SAMU for fall. This assessment is based on the EGS and the assessment of risk factors for falls (HAS, INPES).

Intervention Type OTHER

Proposal for a personalized intervention plan (PIP)

A PIP containing personalized recommendations to improve the patient's state of health, treatment and environment as well as risk factors for falls is proposed during the multi-professional consultation and discussed by telephone with the attending physician (pre-arranged telephone appointment). with the latter).

The PIP validated by the attending physician is delivered and explained to the patient by the Gerontological Assessment Nurse in the week following the Multidisciplinary Team Meeting (MDTM) during the V1 visit to the patient's home.

Intervention Type OTHER

Follow-up

Four follow-up visits at 6, 12, 18 and 24 months (V2, V3, V4, V5) are performed at the patient's home. During these visits, the Gerontological Assessment Nurse reassesses the person from the gerontological point of view and from the point of view of risk factors for falls.

A mail containing the elements of interest is sent to the attending physician after each visit. The patient is also contacted by telephone by the Gerontological Assessment Nurse at 2, 4, 9, 15 and 21 months of follow-up to maintain a link, identify possible difficulties and encourage him / her to apply the PIP recommendations.

Intervention Type OTHER

Usual care

The patients included in the "control" group will benefit from the usual care as well as documentation on general recommendations to be put in place to prevent falls and to age in good health \[series of brochures published by INPES for the elderly. They are informed by telephone of their home group by the Gerontological Assessment Nurse. The documents are sent by mail to the patient's home address.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Living at home
* Living at maximum 45 minutes from a hospital center participating in the study (for logistical reasons and practices of study organization)
* Intervention of the SAMU for a fall at home without there being hospitalization or with hospitalization lasting less than 24h
* Patient or trusted person capable of giving telephone information
* Patient or his / her trusted person who has agreed to participate in the study
* Patient affiliated to a social security scheme

Exclusion Criteria

* Total dependency (ADL at 0)
* Entry in nursing home already scheduled within 3 months
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fati Nourhashemi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CH Albi

Albi, , France

Site Status

CH Cahors

Cahors, , France

Site Status

CH Castres-Mazamet

Castres, , France

Site Status

CHIVA

Foix, , France

Site Status

CH Lannemezan

Lannemezan, , France

Site Status

CH Lavaur

Lavaur, , France

Site Status

CH Montauban

Montauban, , France

Site Status

CH Rodez

Rodez, , France

Site Status

CH Ariège Couserans

Saint-Girons, , France

Site Status

CH Bigorre

Tarbes, , France

Site Status

University Hospital Toulouse

Toulouse, , France

Site Status

Maison de Santé Pluri-professionnelle

Vic-Fezensac, , France

Site Status

Countries

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France

References

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Bouzid W, Tavassoli N, Berbon C, Qassemi S, Bounes V, Azema O, Shourick J, Nourhashemi F. Impact of a personalised care plan for the elderly calling emergency medical services after a fall at home: The RISING-DOM multi-centre randomised controlled trial protocol. BMC Geriatr. 2022 Mar 4;22(1):182. doi: 10.1186/s12877-022-02850-w.

Reference Type RESULT
PMID: 35246053 (View on PubMed)

Bouzid W, Tavassoli N, Berbon C, Qassemi S, Vaysset S, Poly M, Bounes V, Shourick J, Nourhashemi F. Exploring Population Characteristics and Recruitment Challenges in Older People Experiencing Falls at Home without Hospitalization or with an Emergency Department Visit: Insights from the RISING-DOM Experience. Clin Interv Aging. 2023 Dec 1;18:1995-2008. doi: 10.2147/CIA.S421053. eCollection 2023.

Reference Type RESULT
PMID: 38058551 (View on PubMed)

Ailliaud A, Moulis E, Vaysset S, Berbon C, Tavassoli N, Bouzid W, Oliveira Soares C, Qassemi S, Nourashemi F. [Assessment in the home of the elderly following a first fall with Samu intervention]. Soins Gerontol. 2022 Jan-Feb;27(153):23-25. doi: 10.1016/j.sger.2021.11.008. Epub 2021 Nov 24. French.

Reference Type RESULT
PMID: 35120719 (View on PubMed)

Other Identifiers

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RC31/17/0453

Identifier Type: -

Identifier Source: org_study_id