Risk of Frailty in ElderlyDEPARTNCT04012840
Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly
An observational study of Risk of Frailty in Elderly, run by Gérond'if at 1 site in France.
Trial summary
As an active and healthy ageing, "Successful Ageing" is a societal challenge for all countries members according to the European Commission. This study is intended to contribute to increase healthy, active and non-dependent lifetime. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Risk of Frailty in Elderly
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2018to 25 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: : +70 years old elderly with a potential frailty whose accept to participate to a geriatric assessment in a prevention center or in a day hospital and to be followed bwith phone calls every 6 months for 3 years.
Who may be able to join
- Age ≥ 70 years old
- Patient with frailty risks according to a survey recommended by HAS (Gérontopôle of Toulouse)
- ADL≥5
- Agreeing to take part in a geriatric assessment in a prevention center or in a Day hospital in Île-de-France
- Agreeing to be followed by phone every 6 months for 3 years
- Eligible to a social security system
Who cannot join
- A stated loss of autonomy
- Individual under guardianship, curatorship, judicial supervision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Geriatric Department
Paris, Île-de-France Region, 75000
Olivier Hanon, PhD, olivier.hanon@aphp.fr
About this study
As an active and healthy ageing, "Successful Ageing" is a societal challenge for all countries members according to the European Commission. This study is intended to contribute to increase healthy, active and non-dependent lifetime. To this end the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses.
Read the detailed description
Detailed Description:
Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Example:
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD). Healthy, active and non-dependent lifetime during ageing is a societal challenge for European Union. One of the worst consequences of ageing is the loss of autonomy which may be preceded by a mid-state between good and pathological ageing. This mid-state is called "frailty syndrome" and cause a lot of hospitalizations (Morley et al., 2013). This statement is potentially reversible if early procedures mixing geriatric interventions based on standardised geriatric evaluation and general practitioners cooperation are established (Haute Autorité de Santé, 2013). The main studied interventions are physical training, cognitive stimulation and nutritional actions (Bibas et al., 2014; Clegg et al., 2013). Frailty syndrome is a geriatric syndrome emphasizes by the homeostatic reserves drop which induces a stress response failure and expose the person to a wrong medical prognosis (Clegg et al., 2013; Rodriguez-Manas et al., 2013; Rolland et al., 2011). Its clinical expression is modulated by comorbidities and psychological, social, economic and behavioural factors. Thus, frailty syndrome is a mortality risk and pejorative events factor, especially those of loss of autonomy, falls, hospitalizations and institutionalization in a 1 to 3 years delay. So, the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses. If there is no strict frailty definition, two frailty criteria types are officially used :
- Fried's criteria are the more commonly used criteria to diagnose frailty (Fried et al., 2001):
- Involuntary weight loss > 4.5 kg in one year,
- A feeling of exhaustion,
- Low muscle strength (handgrip <20% norm for age, sex and self- bmi),
- Low physical activity (<383 kcal/week spent for men, <270kcal/week for women)
- Low walking speed (<0.8m/s). According to the number of Fried's criteria, subjects are considered frail (≥ 3 criteria), pre-frail (1-2 criteria) or robust (0 criterion).
- Rockwood (Rockwood et al., 2005) or Winograd's criteria (Winograd et al., 1988) based on the mix of medical and social factors also known as "multidomain frailty" incorporate additional pattern of comorbidities (70 parameters in Rockwood's criteria) and geriatric syndromes (confusion, dementia, bed sores, falls, malnourishment…) which actually are too general and leading to detect patients too late.
To diagnose and evaluate this frailty a global geriatric evaluation based on the multidimensional comprehensive geriatric assessment (Haute Autorité de Santé, 2013) must be led, which is a long process specifically realized in geriatrics. Due to several limits in both Fried' and Rockwood's criterion. In Fried's model the slow of walking speed is hard to evaluate, the exhaustion of the patient can depend on a previous psychological state (Drey et al., 2011), also the measure of muscle strength which requires a dynamometer is not always achievable for example. Likewise, in Rockwood's criteria the whole 70 variables are too long to list, even under its short form which includes 30 variables.
Thus, since there is no easy-to-use consensual tool, the real frailty in elderly is nowadays rarely detected. Yet it remains essential to identify the mains biological or clinical factors which will forecast the loss of autonomy. The highlighting of those factors would allow an earlier screening in order to propose several interventions to delay the loss of autonomy.
Non interventional and prospective study in which recruitment and frailty evaluation will be realized in a special geriatric ward (medical examination in day hospital and preventive center). This study bases its choice of patient on the results of a 6 questions survey (from the Gérontopôle of Toulouse) about frailty.
- The main objective is to highlight the clinical and biological determinants of loss of autonomy in non-dependent and potentially frail elderly.
- Secondaries objectives are to highlight the clinical and biological determinants of loss of autonomy in non-dependent and potentially frail elderly by testing :
- Cognitive disorders;
- Risk of falls;
- Malnourishment;
- Depression;
- New illnesses appearances;
- Unscheduled hospitalizations;
- Mortality;
- Institutionalization;
- Evaluate the impact of the geriatrician subjective impression on the loss of autonomy.
People will be recruited among patients whose consult in prevention centers and day hospitals in Île-de-France :
- 9 geriatric centers
- 2000 patients will be included over 36 months
- Approximatively 7 patients per week in each center
- Inclusions will take place for 3 years
- A following up call every 6 months for 3 years
- Conditions
- Risk of Frailty in Elderly
- Keywords
- Frailty, Fried's criteria, Rockwood's criteria, Loss of autonomy,, elderly
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of 1 or more point in activities of daily living (ADL) score which assert a loss of autonomy - Loss of 1 or more point in instrumental activities of daily living (IADL) score which assert a loss of autonomy During the monitoring, those evaluatio
Measured: 3 years
Secondary outcomes (4)
Assessment of ccurrence of cognitive disorders according Mini Mental State Examination (MMSE)
Measured: 3 years
Occurrence of drivers of risk of falls : search for orthostatic hypotension (occurrence or missing), leg stance, tandem station, SPPB, TUG, grip force.
Measured: 3 years
Constated malnourishment according Mini Nutritional Assessment MNA short form
Measured: 3 years
Occurrence of a depression according Mini Geriatric Depression Scale "mini GDS" ≥ 1
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start26 Jun 2018
- Primary completion25 Jun 2030 (estimated)
- Study completion25 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of Frailty in ElderlyStudies 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD PhD, Study chair, Geriatrci Department, Broca Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012840
- Sponsor's protocol ID
- 2018-A00254-51
- Acronym
- DEPART
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly
- ClinicalTrials.gov ID
- NCT04012840
- Acronym / sponsor ID
- DEPART / 2018-A00254-51
- Conditions
- Risk of Frailty in Elderly
- Keywords
- Frailty, Fried's criteria, Rockwood's criteria, Loss of autonomy,, elderly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 25 Jun 2030 (estimated)
- Study completion
- 25 Dec 2030 (estimated)
- First posted
- 9 Jul 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.
As an active and healthy ageing, "Successful Ageing" is a societal challenge for all countries members according to the European Commission. This study is intended to contribute to increase healthy, active and non-dependent lifetime. To this end the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses.
Detailed description
Detailed Description:
Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Example:
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD). Healthy, active and non-dependent lifetime during ageing is a societal challenge for European Union. One of the worst consequences of ageing is the loss of autonomy which may be preceded by a mid-state between good and pathological ageing. This mid-state is called "frailty syndrome" and cause a lot of hospitalizations (Morley et al., 2013). This statement is potentially reversible if early procedures mixing geriatric interventions based on standardised geriatric evaluation and general practitioners cooperation are established (Haute Autorité de Santé, 2013). The main studied interventions are physical training, cognitive stimulation and nutritional actions (Bibas et al., 2014; Clegg et al., 2013). Frailty syndrome is a geriatric syndrome emphasizes by the homeostatic reserves drop which induces a stress response failure and expose the person to a wrong medical prognosis (Clegg et al., 2013; Rodriguez-Manas et al., 2013; Rolland et al., 2011). Its clinical expression is modulated by comorbidities and psychological, social, economic and behavioural factors. Thus, frailty syndrome is a mortality risk and pejorative events factor, especially those of loss of autonomy, falls, hospitalizations and institutionalization in a 1 to 3 years delay. So, the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses. If there is no strict frailty definition, two frailty criteria types are officially used :
- Fried's criteria are the more commonly used criteria to diagnose frailty (Fried et al., 2001):
- Involuntary weight loss > 4.5 kg in one year,
- A feeling of exhaustion,
- Low muscle strength (handgrip <20% norm for age, sex and self- bmi),
- Low physical activity (<383 kcal/week spent for men, <270kcal/week for women)
- Low walking speed (<0.8m/s). According to the number of Fried's criteria, subjects are considered frail (≥ 3 criteria), pre-frail (1-2 criteria) or robust (0 criterion).
- Rockwood (Rockwood et al., 2005) or Winograd's criteria (Winograd et al., 1988) based on the mix of medical and social factors also known as "multidomain frailty" incorporate additional pattern of comorbidities (70 parameters in Rockwood's criteria) and geriatric syndromes (confusion, dementia, bed sores, falls, malnourishment…) which actually are too general and leading to detect patients too late.
To diagnose and evaluate this frailty a global geriatric evaluation based on the multidimensional comprehensive geriatric assessment (Haute Autorité de Santé, 2013) must be led, which is a long process specifically realized in geriatrics. Due to several limits in both Fried' and Rockwood's criterion. In Fried's model the slow of walking speed is hard to evaluate, the exhaustion of the patient can depend on a previous psychological state (Drey et al., 2011), also the measure of muscle strength which requires a dynamometer is not always achievable for example. Likewise, in Rockwood's criteria the whole 70 variables are too long to list, even under its short form which includes 30 variables.
Thus, since there is no easy-to-use consensual tool, the real frailty in elderly is nowadays rarely detected. Yet it remains essential to identify the mains biological or clinical factors which will forecast the loss of autonomy. The highlighting of those factors would allow an earlier screening in order to propose several interventions to delay the loss of autonomy.
Non interventional and prospective study in which recruitment and frailty evaluation will be realized in a special geriatric ward (medical examination in day hospital and preventive center). This study bases its choice of patient on the results of a 6 questions survey (from the Gérontopôle of Toulouse) about frailty.
- The main objective is to highlight the clinical and biological determinants of loss of autonomy in non-dependent and potentially frail elderly.
- Secondaries objectives are to highlight the clinical and biological determinants of loss of autonomy in non-dependent and potentially frail elderly by testing :
- Cognitive disorders;
- Risk of falls;
- Malnourishment;
- Depression;
- New illnesses appearances;
- Unscheduled hospitalizations;
- Mortality;
- Institutionalization;
- Evaluate the impact of the geriatrician subjective impression on the loss of autonomy.
People will be recruited among patients whose consult in prevention centers and day hospitals in Île-de-France :
- 9 geriatric centers
- 2000 patients will be included over 36 months
- Approximatively 7 patients per week in each center
- Inclusions will take place for 3 years
- A following up call every 6 months for 3 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- : +70 years old elderly with a potential frailty whose accept to participate to a geriatric assessment in a prevention center or in a day hospital and to be followed bwith phone calls every 6 months for 3 years.
Key inclusion criteria (6 listed)
- Age ≥ 70 years old
- Patient with frailty risks according to a survey recommended by HAS (Gérontopôle of Toulouse)
- ADL≥5
- Agreeing to take part in a geriatric assessment in a prevention center or in a Day hospital in Île-de-France
- Agreeing to be followed by phone every 6 months for 3 years
Key exclusion criteria (2 listed)
- A stated loss of autonomy
- Individual under guardianship, curatorship, judicial supervision
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
Loss of 1 or more point in activities of daily living (ADL) score which assert a loss of autonomy - Loss of 1 or more point in instrumental activities of daily living (IADL) score which assert a loss of autonomy During the monitoring, those evaluatio
Time frame: 3 years
4 secondary outcomes
Assessment of ccurrence of cognitive disorders according Mini Mental State Examination (MMSE)
Time frame: 3 years
Occurrence of drivers of risk of falls : search for orthostatic hypotension (occurrence or missing), leg stance, tandem station, SPPB, TUG, grip force.
Time frame: 3 years
Constated malnourishment according Mini Nutritional Assessment MNA short form
Time frame: 3 years
Occurrence of a depression according Mini Geriatric Depression Scale "mini GDS" ≥ 1
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Olivier Hanon, MD PhD study chair
Geriatrci Department, Broca Hospital
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 Risk of Frailty in Elderly, run by Gérond'if 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 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: looking for participants now, as of the sponsor's last update on 16 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dufour (+33 (0) 185781011, Isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of 1 or more point in activities of daily living (ADL) score which assert a loss of autonomy - Loss of 1 or more point in instrumental activities of daily living (IADL) score which assert a loss of autonomy During the monitoring, those evaluatio (time frame: 3 years). 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 16 Apr 2025.