ElderlyRISING-DOMNCT04132544
Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home
A study testing standardized gerontological evaluation (EGS), Proposal for a personalized intervention plan (PIP) and Follow-up in people with Elderly, run by University Hospital, Toulouse at 12 sites in France.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- standardized gerontological evaluation (EGS), Proposal for a personalized intervention plan (PIP) and Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Oct 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Total dependency (ADL at 0)
- Entry in nursing home already scheduled within 3 months
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CH Albi
Albi
CH Cahors
Cahors
CH Castres-Mazamet
Castres
CHIVA
Foix
CH Lannemezan
Lannemezan
CH Lavaur
Lavaur
CH Montauban
Montauban
CH Rodez
Rodez
CH Ariège Couserans
Saint-Girons
CH Bigorre
Tarbes
University Hospital Toulouse
Toulouse, 31059
Maison de Santé Pluri-professionnelle
Vic-Fezensac
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Elderly
- Being tested
- standardized gerontological evaluation (EGS), Proposal for a personalized intervention plan (PIP), Follow-up, Usual care
- Keywords
- risks factors, Fall Patients, elderly, Urgent Medical Assistance Service, Emergency Care, 911
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized gerontological evaluation (EGS)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)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-upOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | * a standardized gerontological evaluation (EGS) and a fall balance performed at home or teleconsultation 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). Receives: Other: standardized gerontological evaluation (EGS); Other: Proposal for a personalized intervention plan (PIP); Other: Follow-up |
| Comparison group - usual care | Active comparator | Usual Care with the provision of documentation on simple recommendations for the prevention of falls and aging well. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The delay between the T0 and Time of occurrence
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.
Measured: 2 years
Secondary outcomes (7)
Number of reminders to the SAMU for fall
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.
Measured: 2 years
Number of non-programmed hospitalizations
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.
Measured: 2 years
Evolution of the dependence level evaluated by the ADL scale
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.
Measured: 2 years
Evolution of the quality-of-life score evaluated by Short Form -12
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):
- a score of quality of mental and social life
- and a physical quality of life score.
Measured: 2 years
Number of deceased or institutionalized subjects
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.
Measured: 2 years
Time to institutionalization
The time from T0 to the occurrence of institutionalization will be compared between the two groups until the end of the study (i.e. 54 months for the first patient included). This information will be collected in both groups during the semi-annual follow-up telephone calls, blinded to the participants' group allocation.
Measured: 2 years (up to 54 months for early inclusion)
Time to death
The time from T0 to the occurrence of death will be compared between the two groups until the end of the study (i.e. 54 months for the first patient included). This information will be collected in both groups during the semi-annual follow-up telephone calls, blinded to the participants' group allocation.
In the event of institutionalization, the clinical research associate will collect the date and cause of death, if applicable, in both groups within the 12 months following admission to a nursing home and/or before the end of the study.
Measured: 2 years (up to 54 months for early inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Oct 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional multicenter and open, randomized study in parallel groups comparing two arms
- Masking
- None (open label)
- Enrolment
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fati Nourhashemi, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132544
- Sponsor's protocol ID
- RC31/17/0453
- Acronym
- RISING-DOM
- Status last verified
- May 2024
- First submitted
- 15 Oct 2019
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35246053Bouzid 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.
PubMed 38058551Ailliaud 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.
PubMed 35120719
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04132544
- Acronym / sponsor ID
- RISING-DOM / RC31/17/0453
- Conditions
- Elderly
- Keywords
- risks factors, Fall Patients, elderly, Urgent Medical Assistance Service, Emergency Care, 911
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional multicenter and open, randomized study in parallel groups comparing two arms
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: standardized gerontological evaluation (EGS), Other: Proposal for a personalized intervention plan (PIP), Other: Follow-up* a standardized gerontological evaluation (EGS) and a fall balance performed at home or teleconsultation 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). |
| Comparison group - usual care | Active comparator | Other: Usual careUsual Care with the provision of documentation on simple recommendations for the prevention of falls and aging well. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Total dependency (ADL at 0)
- Entry in nursing home already scheduled within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Intervention group |
| 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. | Other | Intervention group |
| Follow-upFour 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. | Other | Intervention group |
| Usual careThe 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. | Other | Comparison group - usual care |
Primary outcome
The delay between the T0 and Time of occurrence
Time frame: 2 years
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.
7 secondary outcomes
Number of reminders to the SAMU for fall
Time frame: 2 years
Number of non-programmed hospitalizations
Time frame: 2 years
Evolution of the dependence level evaluated by the ADL scale
Time frame: 2 years
Evolution of the quality-of-life score evaluated by Short Form -12
Time frame: 2 years
Number of deceased or institutionalized subjects
Time frame: 2 years
Time to institutionalization
Time frame: 2 years (up to 54 months for early inclusion)
Time to death
Time frame: 2 years (up to 54 months for early inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 35246053Bouzid 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.
- Results publication: PubMed 38058551Bouzid 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.
- Results publication: PubMed 35120719Ailliaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fati Nourhashemi, MD principal investigator
University Hospital, Toulouse
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized gerontological evaluation (EGS), Proposal for a personalized intervention plan (PIP) and Follow-up in people with Elderly, run by University Hospital, Toulouse at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The delay between the T0 and Time of occurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04132544, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.