Cohorts
IPC cohort (Centre for Preventive and Clinical Investigation)
(in progress)
Context: Studies highlighting the determinants of loss of autonomy are rare. Creating a longitudinal cohort of ambulatory, autonomous patients who have consulted in an IPC center will provide more information on the determinants of the risk of loss of autonomy. 'autonomy.
Purpose of the study : To follow a cohort of subjects aged over 65, having gone to an IPC center to carry out a Periodic Health Examination (EPS), as part of the free Periodic Health Examination offered by health insurance.
Main objective : To highlight the determinants of the risk of loss of autonomy in non-dependent elderly subjects.
Secondary objectives : Closely monitor the evolution of subjects in terms of :
- Unscheduled hospitalizations
- Occurrence of cognitive disorders and depression
- Occurrence of falls and fractures
- Occurrence of malnutrition
- Occurrence of new diseases (cancer, cardiovascular pathologies, neurological pathologies, etc.)
- Entry into an institution
Study methodology : Observational, prospective study.
Total duration of the study : 10 years
Location of the study : CPI Center
Investigator Coordinator : Prof. Olivier HANON, AP-HP
Promoter : Gérond'if
Funding: Gérond'if
ELCAPA cohort (ELderly CAncer PATIENT)
(in progress)
context : Validating the results of therapeutic trials on elderly subjects with cancer in order to adapt cancer treatments for this population.
Purpose of the study : To follow a cohort of subjects aged 70 and over, suffering from any type of cancer, referred to a geriatrician for a standardized geriatric assessment.
Main objective of the study: To determine the frequency of failure to carry out the cancer treatment plan and each type of treatment in elderly patients with solid cancer.
Secondary objective : Identify the factors associated with this non-implementation of the treatment plan, by carrying out a standardized follow-up including the collection of overall survival, disease progression, specific survival, implementation of the treatment plan, changes in the initial treatment plan, loss of autonomy, toxicities and hospitalizations...
Study methodology : observational, prospective, multicenter study
Number of subjects included in the study : 6000
Duration of the study : 15 years
Location of the study : 19 UCOG from the Ile-de-France region
Investigator Coordinator : Prof. Philippe CAILLET, AP-HP
Funding : INCA, UPEC, Cancéropôle d'Ile-de-France, CEPIA, Gérond'if
INSIGHT cohort
(in progress)
Interest of the study : INSIGHT is an innovative study on Alzheimer's disease, and one of the first in the world to follow healthy subjects at risk. The interest of this study is to better understand the natural evolution of preclinical states (dynamic processes) Alzheimer's disease (AD), in order to offer treatment subjects at risk to delay the onset of clinical signs.
Purpose of the study : To follow more than 400 subjects, aged 75 to 85, in good health and complaining of their memory.
Primary objective : To analyze the differences in amyloid load between the subjects “ prodromal » likely to progress to AD and healthy subjects.
Secondary objectives :
- Identify the evolution of the physiopathological process and study the early signs (abnormalities on MRI, PET or EEG, cognitive performance, disturbances in daily life, blood tests and cerebrospinal fluid biomarkers) suggestive of a MY.
- Determine the risk factors and triggers of AD
- Establish correlations between the data obtained from MRI and those from PET scans concerning the amyloid load of the participants
- Propose effective therapeutic approaches
Study methodology : monocentric observational study
Number of subjects included : 350
Duration of study : 5-6 years
Location of the study : Paris, IM2A site at La Pitié-Salpêtrière Hospital
Coordinating Investigator : Pr. Bruno DUBOIS
FRAGILITY cohort
(under submission)
Goals of the study: Follow 2000 subjects suspected of frailty according to the questionnaire recommended by the HAS (Gérontopôle de Toulouse), included during a geriatric consultation in a prevention center or HDJ frailty.
Main objective : To highlight the clinical and biological determinants of the loss of autonomy in potentially fragile non-dependent elderly subjects.
Secondary objectives : Highlight in these subjects; the clinical and biological determinants of the risk of:
- Unscheduled hospitalizations
- Mortality
- Entry into an institution
- Occurrence of cognitive disorders and depression
- Occurrence of falls and fractures
- Occurrence of malnutrition
- Occurrence of new diseases (cancer, cardiovascular pathologies, neurological pathologies, etc.)
Evaluate the impact of the subjective impression of the geriatrician and the patient on the loss of autonomy
Study methodology: Non-interventional, multicenter, prospective study
Number of subjects included: 2000
Location: Ile-de-France
Total study duration: 5 years
Coordinating Investigator: Pr. Olivier HANON, AP-HP
Promoter: Gérond'if
Funding: Gérond'if
©YvesGellie
Prevention
EMMAP study
(in progress)
Context: Prif organizes prevention workshops, open to all Ile-de-France retirees from the CNAV, RSI and MSA. Gérond'if was asked to evaluate the effectiveness of the workshops moving balance which are part of this prevention offer.
Purpose of the study: To evaluate the effectiveness of the workshops moving balance », on the muscular function of the participants, compared to a control group.
Main objective : to measure the impact of the workshops (12 sessions in 3 months) on walking speed
Secondary objective : compare the variations in the two groups, nutritional and muscular parameters such as weight, grip strength, calf circumference, percentage of fat mass and lean mass, etc.
A group of witnesses :workshop participants memory » du Prif (12 sessions in 3 months).
Methodology : non-interventional, prospective and comparative study.
Number of subjects included : 520, 270 in each group
Total duration of the study : 2 years and 10 months
Location of the study : everywhere in Ile-de-France
Investigator Coordinator : Prof. Agathe RAYNDAUD-SIMON, AP-HP
Promoter : Gérond'if
Funding : Prif
PREPAD study
(under submission)
Context : Preventive actions and their evaluation are still rare in the field of frailty prevention. This study aims to set up an action to prevent the loss of autonomy of non-institutionalised elderly people, through physical activity.
Purpose of the study : Set up and evaluate a collective action, in municipalities (2 in the pilot phase: Sevran and Aulnay-sous-Bois) using in particular specifically adapted weight machines by a French company.
Primary objective : To evaluate the impact of a physical exercise program, carried out with adapted muscle strengthening devices, on the loss of autonomy in acts of daily living, in people aged over 70 living at home.
Secondary objectives : Determine:
- Compliance with the program
- Effectiveness on muscle function
- The time until the increase in professional home help
- The time until hospitalization or institutionalization
- The impact on the quality of life of the elderly
- The medico-economic interest
Methodology : Interventional, randomized, prospective, comparative study, with 2 arms (interventional and control).
Number of subjects included : 288 (144 in each group)
Total duration of the study : 18 months
Location of the study : Paris, Sevran and Aulnay-sous-Bois
Investigator Coordinator : Pr. Véronique FRANCOIS FASILLE, AP-HP
Promoter : Gérond'if
Funding : PHRC 2017, Conference of Funders of 93
NutriActif study
(under submission)
context : One out of two hospitalized elderly people is malnourished. This state of malnutrition generally worsens during hospitalization. In these cases, muscle wasting linked to insufficient food intake and immobilization results in the appearance or aggravation of mobility disorders and dependence. Actions limited to the hospital are not enough to reduce the risk of rehospitalization, it is essential to continue these actions at home.
Purpose of the study : To set up and evaluate a care program at home, combining nutritional support (NS) and adapted physical activity (APA), for elderly people who are malnourished or at risk of malnutrition, leaving hospital to go home.
Main objective : To evaluate the effect of care combining nutritional support and appropriate physical activity on the autonomy of elderly people leaving hospital to return home.
Secondary objectives : To determine the effects of this support on :
- Nutritional status
- Functional status
- Life quality
- Caregiver burden (if applicable)
Medico-social and sociological dimension: cost/effectiveness evaluation, cost/utility, and conditions of acceptability, implementation and generalization of the system.
Methodology : Interventional, randomized, prospective, comparative study, with 4 arms (1 : control group, 2 : APA group, 3 : group SN and 4 : mixed APA+SN intervention).
Total number of subjects included : 400 elderly people (100 per group) + 150 family carers
Total duration of the study : 2 years
Location of the study : Inner Paris
Investigator Coordinator : Prof. Agathe RAYNAUD-SIMON, AP-HP
Promoter : Gérond'if
Funding :Paris Financers Conference
©YvesGellie
EHPAD
Survey on a given day on atrial fibrillation in nursing homes
(finalized)
Purpose of the study : Evaluate care practices in the population of subjects residing in nursing homes with atrial fibrillation or a history of atrial fibrillation, taking into account the numerous associated comorbidities.
Methodology: Non-interventional, retrospective study.
Total number of subjects included: 1300
Location of the study: 88 EHPADs in Ile-de-France
Coordinating investigator: Pr Olivier HANON, AP-HP
Promoter: Gérond'if
Funding : Gérond'if
Night IDE study in EHPAD
(in progress)
Context of the project : Since 2013, the ARS Ile-de-France has launched the IDE de nuit experiment consisting of the creation of a "mobile" night nursing position in an EHPAD with the aim of improving the continuity of care and reducing emergency hospitalizations of residents. These nurses, employed by a "bridgehead" EHPAD, are called upon to intervene in three EHPADs identified in each department.
This experiment aims to:
- Improve the orientation of residents during night hours by helping to better detect risky situations, encourage the use of the SAMU Center 15 if necessary and identify avoidable emergency admissions, within the framework of pre-established procedures and in partnership with the SAMU Center 15.
- Improve the management of residents returning from hospitalization.
- Improve the continuity of care in EHPADs, by securing the teams.
- Improve the training of night staff in nursing homes.
Purpose of the study : The medico-economic study launched in 2016 aims to assess the real impact of the experimental device for shared overnight FDI in EHPADs on improving the health care pathway for the elderly.
Main objective: Evaluate the real impact of the experimental device for shared overnight FDI in EHPADs on improving the health care pathway for the elderly.
Secondary objective: to assess the medico-economic relevance of this device (cost / utility ratio) in order to assess its interest in comparison with other modes of support at night (telephone on-call, telemedicine, HAD, etc. ).
Methodology : Controlled, non-randomized observational study, with prospective and retrospective components.
Duration of the research : The total duration of the study is 22 months (September 2016- June 2018)
Scientific officer : Professor Olivier HANON, Broca Hospital, AP-HP
Promoters : ARS Ile-de-France, Gérond'if
Funding: ARS Ile-de-France
Clinical tests
SAFIR project
Purpose of the study : Evaluating a new oral anticoagulant, Rivaroxaban, in people aged over 80 with non-valvular atrial fibrillation. The study consists precisely in evaluating the metrological qualities of two haemorrhagic scores (HEMORR2HAGES and HAS-BLED) on the occurrence of major and non-major clinically relevant haemorrhages. , in very elderly subjects (over 80 years old) with non-valvular atrial fibrillation, treated with Rivaroxaban
Scientific domain : medical research, cardio-geriatrics
The study project has the following dimensions :
Description of the characteristics of the subjects included in the cohort
Calculation of the predictive value of HEMORR2HAGES and HAS –BLED scores for clinically relevant major and non-major bleeding
Creation of a new bleeding risk score adapted for this specific population and treatment with NOAC
Evaluation of the incidence and determinants of major events (major bleeding, hospitalization, myocardial infarction, stroke, thromboembolic event, death)
Measurement of adherence and persistence to treatment with Rivaroxaban, with Morisky and O2 scores
Measurement of geriatric characteristics (cognition, depression, falls, nutritional status, autonomy, comorbidities, renal function, social environment) at baseline and after one year of follow-up
Project leader (promoter) : CEMKA-EVAL
Principal Investigator : Pr Olivier HANON, Paris 5 University, Broca Hospital, AP-HP Paris
Investigators : geriatricians or cardiologists practicing in metropolitan France
Calendar : 24-month study between March 2014 and March 2016, final report of the study in December 2016
1100 patients followed in 50 centers