Frail Elderly People HospitalizedFRAGILNCT06873256
Evaluation of the Hospital Pathway for Frail Elderly Patients Hospitalised for Pathologies Leading to Medical Decompensation
An observational study of Frail Elderly People Hospitalized, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
People aged over 75 account for 25% of emergency department visits in the Provence Alpes Côte d'Azur region. Depending on the facility, around 50% of these patients are discharged home without being hospitalised. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frail Elderly People Hospitalized
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2025to 24 Jul 2025
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Frail elderly people hospitalized
Who may be able to join
- Patient aged ≥ 75 years;
- Patient cared for at the Intercommunal Hospital Center of Toulon-La Seyne sur Mer (Sainte Musse and Georges Sand hospitals) between 01/09/2024 and 01/03/2025 and presenting a geriatric score ≥ 8 (score defined by multidisciplinary work);
- Patient requiring hospitalisation for medical decompensation.
Who cannot join
- Patient with acute pathologies requiring admission to the intensive care unit;
- Patient whose care is in the field of traumatology in isolation;
- Patient's refusal to take part in the research.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
Toulon, Var, 83100
About this study
People aged over 75 account for 25% of emergency department visits in the Provence Alpes Côte d'Azur region. Depending on the facility, around 50% of these patients are discharged home without being hospitalised. Yet the scientific literature highlights the frequent deterioration in the physical and mental state of the elderly during a visit to the emergency department: discomfort on the stretcher, waiting, loneliness and disorientation are the causes, and therefore increase co-morbidity. Very few studies have been carried out to date to compare the impact on frailty risk factors of direct admission to hospital versus admission via emergency service for a frail elderly population. Studies are usually based on a population aged over 75 as the sole criterion, which no longer corresponds to the definition of a frail elderly person. What's more, there are major challenges in coordinating hospital and outpatient care to optimise resources.
The aim is to assess whether the creation of new care pathways, requiring considerable human and financial resources, will improve the care of frail elderly people. In order to assess the benefits of the systems set up at the hospital this study will compare the outcome of frail elderly people (≥ 75 years old with a geriatric score ≥ 8) hospitalised for medical decompensation pathologies according to their mode of admission, the management of their dependency and their accessibility to the attending physician, whether in individual accommodation or in an Residential Establishment for Dependent Elderly People.
Read more
This is a regional multicentre, observational, prospective and retrospective study looking at the future of frail elderly people hospitalised at the hospital during 2024/2025 (from 01/09/2024 to 01/03/2025).
The study will be conducted retrospectively, including patients hospitalised since 1st September 2024, and prospectively, including patients over time until the end of the inclusion period (01/03/2025). Patients will be followed for 90 days after hospitalisation, i.e. data will be collected until 01/06/2025.
Justification of the public interest
This research could make it possible to identify new protective factors against deterioration in the frail elderly, other than direct admission to a hospital ward, which would require fewer human and material resources, such as an Mobile Geriatric Team or a stay in a Short-Term Hospitalization Unit.
If direct admissions lead to fewer patients being admitted back to hospital, this could encourage existing medical and surgical specialties outside geriatrics and support geriatric assessment.
Lastly, this research would make it possible to draw up an inventory of the frailty of the elderly in the Toulon conurbation, in order to optimise the screening of frail elderly people in conjunction with the territorial care coordination west var region.
Data collection begins as soon as the frail elderly person is hospitalised and continues for up to 90 days after the start of hospitalisation (retrospectively and prospectively).
- Conditions
- Frail Elderly People Hospitalized
- Keywords
- Elderly person, Weakness, Addressing, Nursing home, 911
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail patients hospitalized for medical decompensation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective was to assess the 90-day morbidity and mortality of frail elderly people hospitalized, depending on their mode of hospitalization.
The primary endpoint was early re-hospitalization or death within 90 days, depending on the mode of hospitalization (short-term hospital unit, direct admissions and passage via the emergency department).
Measured: 3 months
Secondary outcomes (6)
To assess the 30-day morbidity and mortality of frail elderly people hospitalized according to their mode of hospitalization.
Number of early re-hospitalization or death within 30 days, depending on the mode of hospitalization (short-term hospital unit, direct admissions and passage via the emergency department).
Measured: 1 month
Evaluate the prognosis of frailty at a distance, based on the presence of a Mobile Geriatric Team during hospitalization and on the implementation of an assistance plan in conjunction with a hospital social worker, enabling a safe return home.
Number of early re-hospitalizations or deaths at 30 days, depending on the presence of a Mobile Geriatric Team during hospitalization (Yes/No) and the request to set up/organize an assistance plan in conjunction with a social worker (Yes/No/Not applicable).
Measured: 1 month
Evaluate the prognosis of frailty at a distance, based on the presence of a Mobile Geriatric Team during hospitalization and on the implementation of an assistance plan in conjunction with a hospital social worker, enabling a safe return home.
Number of early re-hospitalizations or deaths at 90 days, depending on the presence of a Mobile Geriatric Team during hospitalization (Yes/No) and the request to set up/organize an assistance plan in conjunction with a social worker (Yes/No/Not applicable).
Measured: 3 months
For the sub-group of patients referred from nursing homes, assess the time between the last General Practitioner referral and hospitalization.
Time in days between last medical contact with a general practitioner and hospitalization. The date of the last medical contact will be retrieved from the Residential establishment for dependent elderly people's Emergency Liaison File
Measured: 1 year before hospitalization
Evaluate the proportion of frail patients who have been specifically identified by the territorial care coordination teams prior to hospitalization.
Rate of frail patients identified by the territorial care coordination West Var region (following a report made by a nurse, a doctor or a care assistant) prior to hospitalization, compared to the rate of frail patients hospitalized.
Measured: 1 year before hospitalization
Analyze the patient's destination at the end of the initial hospitalization
The following destinations at discharge from hospitalization will be analyzed: Follow-up and rehabilitation care / Residential establishment for dependent elderly people / Home / Death during hospitalization.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start28 Feb 2025
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly People HospitalizedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc FOURNIER, MD, Study director, Centre Hospitalier Intercommunal Toulon- La Seyne sur mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873256
- Sponsor's protocol ID
- 2024-CHITS-011
- Acronym
- FRAGIL
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hospital Pathway for Frail Elderly Patients Hospitalised for Pathologies Leading to Medical Decompensation
- ClinicalTrials.gov ID
- NCT06873256
- Acronym / sponsor ID
- FRAGIL / 2024-CHITS-011
- Conditions
- Frail Elderly People Hospitalized
- Keywords
- Elderly person, Weakness, Addressing, Nursing home, 911
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 12 Mar 2025 (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.
People aged over 75 account for 25% of emergency department visits in the Provence Alpes Côte d'Azur region. Depending on the facility, around 50% of these patients are discharged home without being hospitalised. Yet the scientific literature highlights the frequent deterioration in the physical and mental state of the elderly during a visit to the emergency department: discomfort on the stretcher, waiting, loneliness and disorientation are the causes, and therefore increase co-morbidity. Very few studies have been carried out to date to compare the impact on frailty risk factors of direct admission to hospital versus admission via emergency service for a frail elderly population. Studies are usually based on a population aged over 75 as the sole criterion, which no longer corresponds to the definition of a frail elderly person. What's more, there are major challenges in coordinating hospital and outpatient care to optimise resources.
The aim is to assess whether the creation of new care pathways, requiring considerable human and financial resources, will improve the care of frail elderly people. In order to assess the benefits of the systems set up at the hospital this study will compare the outcome of frail elderly people (≥ 75 years old with a geriatric score ≥ 8) hospitalised for medical decompensation pathologies according to their mode of admission, the management of their dependency and their accessibility to the attending physician, whether in individual accommodation or in an Residential Establishment for Dependent Elderly People.
This is a regional multicentre, observational, prospective and retrospective study looking at the future of frail elderly people hospitalised at the hospital during 2024/2025 (from 01/09/2024 to 01/03/2025).
The study will be conducted retrospectively, including patients hospitalised since 1st September 2024, and prospectively, including patients over time until the end of the inclusion period (01/03/2025). Patients will be followed for 90 days after hospitalisation, i.e. data will be collected until 01/06/2025.
Justification of the public interest
This research could make it possible to identify new protective factors against deterioration in the frail elderly, other than direct admission to a hospital ward, which would require fewer human and material resources, such as an Mobile Geriatric Team or a stay in a Short-Term Hospitalization Unit.
If direct admissions lead to fewer patients being admitted back to hospital, this could encourage existing medical and surgical specialties outside geriatrics and support geriatric assessment.
Lastly, this research would make it possible to draw up an inventory of the frailty of the elderly in the Toulon conurbation, in order to optimise the screening of frail elderly people in conjunction with the territorial care coordination west var region.
Data collection begins as soon as the frail elderly person is hospitalised and continues for up to 90 days after the start of hospitalisation (retrospectively and prospectively).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail patients hospitalized for medical decompensation | – | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Frail elderly people hospitalized
Key inclusion criteria (3 listed)
- Patient aged ≥ 75 years;
- Patient cared for at the Intercommunal Hospital Center of Toulon-La Seyne sur Mer (Sainte Musse and Georges Sand hospitals) between 01/09/2024 and 01/03/2025 and presenting a geriatric score ≥ 8 (score defined by multidisciplinary work);
- Patient requiring hospitalisation for medical decompensation.
Key exclusion criteria (3 listed)
- Patient with acute pathologies requiring admission to the intensive care unit;
- Patient whose care is in the field of traumatology in isolation;
- Patient's refusal to take part in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The main objective was to assess the 90-day morbidity and mortality of frail elderly people hospitalized, depending on their mode of hospitalization.
Time frame: 3 months
The primary endpoint was early re-hospitalization or death within 90 days, depending on the mode of hospitalization (short-term hospital unit, direct admissions and passage via the emergency department).
6 secondary outcomes
To assess the 30-day morbidity and mortality of frail elderly people hospitalized according to their mode of hospitalization.
Time frame: 1 month
Evaluate the prognosis of frailty at a distance, based on the presence of a Mobile Geriatric Team during hospitalization and on the implementation of an assistance plan in conjunction with a hospital social worker, enabling a safe return home.
Time frame: 1 month
Evaluate the prognosis of frailty at a distance, based on the presence of a Mobile Geriatric Team during hospitalization and on the implementation of an assistance plan in conjunction with a hospital social worker, enabling a safe return home.
Time frame: 3 months
For the sub-group of patients referred from nursing homes, assess the time between the last General Practitioner referral and hospitalization.
Time frame: 1 year before hospitalization
Evaluate the proportion of frail patients who have been specifically identified by the territorial care coordination teams prior to hospitalization.
Time frame: 1 year before hospitalization
Analyze the patient's destination at the end of the initial hospitalization
Time frame: Up to 1 month
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 20 Nov 2025.
- The predictive validity of frailty status for hospitalization and mortality. In: The predictive validity of the state of frailty for hospitalization and mortality. Toulouse: The 2016 Gerontological Year; 2016. p. 49 49.Brun M. C3S Coordination Support ScLink provided by the sponsor.
- Report of the Hospital and Elderly Persons WorkshopLink provided by the sponsor.
- ICOPE - A program to prevent addiction \[Internet\]. 2023 \[cited 2024 Sep 22\].Link provided by the sponsor.
- Elderly people in the emergency room: a more fragile health requiring longer care: Studies and results 2017; N°1008 Electronic ISSN 1146-9129.Link provided by the sponsor.
- Hospital emergencies in 2023: what organizations for patient care? Studies and results 2024 N°1305; Electronic ISSN 1146-9129.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Marc FOURNIER, MD study director
Centre Hospitalier Intercommunal Toulon- La Seyne sur mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly People Hospitalized, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site 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 3 inclusion and 3 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 main objective was to assess the 90-day morbidity and mortality of frail elderly people hospitalized, depending on their mode of hospitalization. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.