Condition or disease |
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Risk of Frailty in Elderly |
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly |
Actual Study Start Date : | June 26, 2018 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | June 2024 |
Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria :
Exclusion criteria :
Contact: Isabelle Dufour | +33 (0) 185781011 | Isabelle.dufour@gerondif.org | |
Contact: Margot Bobin | +(33) 185781013 | margot.bobin@gerondif.org |
France | |
Geriatric Department | Recruiting |
Paris, Île-de-France, France, 75000 | |
Contact: Olivier Hanon, PhD olivier.hanon@aphp.fr |
Study Chair: | Olivier Hanon, MD PhD | Geriatrci Department, Broca Hospital |
Tracking Information | |||||||||
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First Submitted Date | July 2, 2019 | ||||||||
First Posted Date | July 9, 2019 | ||||||||
Last Update Posted Date | July 9, 2019 | ||||||||
Actual Study Start Date | June 26, 2018 | ||||||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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 ] | ||||||||
Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly | ||||||||
Official Title | Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly | ||||||||
Brief 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. 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. (Limit: 32,000 characters) 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 :
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.
People will be recruited among patients whose consult in prevention centers and day hospitals in Île-de-France :
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
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. | ||||||||
Condition | Risk of Frailty in Elderly | ||||||||
Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
2000 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | June 2024 | ||||||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion criteria :
Exclusion criteria :
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Sex/Gender |
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Ages | 70 Years and older (Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04012840 | ||||||||
Other Study ID Numbers | 2018-A00254-51 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Gérond'if | ||||||||
Study Sponsor | Gérond'if | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Gérond'if | ||||||||
Verification Date | June 2019 |