Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04012840 |
| Other study ID # |
2018-A00254-51 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 26, 2018 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Gérond'if |
| Contact |
Isabelle Dufour |
| Phone |
+33 (0) 185781011 |
| Email |
Isabelle.dufour[@]gerondif.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. To this end the main goal is to
highlight clinical and biological frailty determinants in elderly with potential weaknesses.
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 :
1. 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).
2. 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
