- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132544
Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home (RISING-DOM)
Impact of an Assessment of Risk Factors for Falls and Personalized Care, on Mortality and Institutionalization, After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fati Nourhashemi, MD
- Phone Number: 33 5 61 77 70 38
- Email: nourhashemi.f@chu-toulouse.fr
Study Contact Backup
- Name: Arnaud Lendrieux
- Phone Number: 05 61 77 84 90
- Email: lendrieux.a@chu-toulouse.fr
Study Locations
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-
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Albi, France
- CH Albi
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Cahors, France
- CH Cahors
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Castres, France
- CH Castres-Mazamet
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Foix, France
- CHIVA
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Lannemezan, France
- CH Lannemezan
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Lavaur, France
- CH Lavaur
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Montauban, France
- CH Montauban
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Rodez, France
- CH Rodez
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Saint-Girons, France
- CH Ariège Couserans
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Tarbes, France
- CH Bigorre
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Toulouse, France, 31059
- University Hospital Toulouse
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Vic-Fezensac, France
- Maison de Santé Pluri-professionnelle
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Comparison group - usual care
Usual Care with the provision of documentation on simple recommendations for the prevention of falls and aging well.
|
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.
|
Experimental: Intervention group
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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).
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The delay between the T0 and Time of occurrence
Time Frame: 2 years
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The composite criterion corresponding to the delay between the T0 and the occurrence of an institutionalization or a death before institutionalization (first event occurring). In this pilot study, the average age of subjects was 83.6 years. This is a population for which the goals of home care and delay in the onset of dependence and in the occurrence of death are interesting and feasible. |
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of reminders to the SAMU for fall
Time Frame: 2 years
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The average number of SAMU recalls for drop during the follow-up period will be compared between the two groups at 12 and 24 months after inclusion.
This data is collected from a regional database of regulatory data in partnership with the Regional Health Agency (ARS) for all subjects included.
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2 years
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Number of non-programmed hospitalizations
Time Frame: 2 years
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Hospitalizations will be collected for all patients included during the follow-up. We will compare more specifically the unplanned hospitalizations: the average number of unplanned hospitalizations will be compared between the two groups at 12 and 24 months of follow-up. This data is collected during the unannounced semi-annual telephone call of the subjects' home groups. |
2 years
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Evolution of the dependence level evaluated by the ADL scale
Time Frame: 2 years
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Katz's scale of functional independence for activities of daily living (Katz S, 1963), commonly known as Katz's ADL (Katz Activity of Living Living Scale), is the most appropriate tool for assessing functional abilities.
basic patient.
Clinicians generally use this tool to detect problems with performing 6 basic activities of daily living and to plan care accordingly.
The score varies from 0 (completely dependent) to 6 (completely autonomous).
A score of 4 indicates a moderate functional deficit and 2 a severe functional deficit.
|
2 years
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Number of deceased or institutionalized subjects
Time Frame: 2 years
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The number of deceased or institutionalized subjects during the follow-up period will be compared between the two groups at 12 and at 24 months of follow-up.
This data is collected in both groups during the unannounced semiannual telephone call of the groups belonging to the subjects.
|
2 years
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Evolution of the quality-of-life score evaluated by Short Form -12
Time Frame: 2 years
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The investigators will use the Short Form-12 Quality of Life Scale, which is an abbreviated version of the Medical Outcomes Study Short-Form General Health Survey, with only 12 of the 36 questions that can save a lot of time. It is a generic questionnaire that makes it possible to compare groups of subjects with different pathologies. It measures eight aspects of quality of life that reflect World Health Organization (WHO) definition of quality of life: general and mental health, physical and social functioning, physical and emotional health, pain and vitality. Compared to the Short Form-36, the Short Form-12 has the advantage of being shorter, less time-consuming, thus easier for the evaluator and better tolerated by patients. Its results are correlated with those of the Short Form-36. The Short Form-12 allows to obtain two scores (between 0 and 100, calculated thanks to an algorithm):
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fati Nourhashemi, MD, University Hospital, Toulouse
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC31/17/0453
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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