Prevention

EMMAP study

(in progress)

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• 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.

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• 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.

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Main objective : to measure the impact of the workshops (12 sessions in 3 months) on walking speed

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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.

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A group of witnesses  :workshop participants  memory  » du Prif (12 sessions in 3 months).

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• Methodology  : non-interventional, prospective and comparative study.
   

• Number of subjects included  : 520, 270 in each group

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• Total duration of the study  : 2 years and 10 months

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• Location of the study  : everywhere in Ile-de-France

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• Investigator Coordinator  : Prof. Agathe RAYNDAUD-SIMON, AP-HP

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• Promoter : Gérond'if

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• Funding : Prif

PREPAD study

(under submission)

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• 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.

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• 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.

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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.

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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

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• Methodology : Interventional, randomized, prospective, comparative study, with 2 arms (interventional and control).

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• Number of subjects included  : 288 (144 in each group)

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• Total duration of the study  : 18 months

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• Location of the study  : Paris, Sevran and Aulnay-sous-Bois

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• Investigator Coordinator  : Pr. Véronique FRANCOIS FASILLE, AP-HP

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• Promoter : Gérond'if

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• Funding  : PHRC 2017, Conference of Funders of 93

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NutriActif study

(under submission)

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• 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.  

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Secondary objectives  : To determine the effects of this support on  :

- Nutritional status

- Functional status

- Life quality

- Caregiver burden (if applicable)

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Medico-social and sociological dimension: cost/effectiveness evaluation, cost/utility, and conditions of acceptability, implementation and generalization of the system.

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• Methodology : Interventional, randomized, prospective, comparative study, with 4 arms (1  : control group, 2  : APA group, 3  : group SN and 4  : mixed APA+SN intervention).

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• Total number of subjects included  : 400 elderly people (100 per group) + 150 family carers

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• Total duration of the study : 2 years

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• Location of the study  : Inner Paris

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• Investigator Coordinator  : Prof. Agathe RAYNAUD-SIMON, AP-HP

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• Promoter : Gérond'if

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• Funding  :Paris Financers Conference

  EHPAD  

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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.

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• Total number of subjects included: 1300

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• Location of the study: 88 EHPADs in Ile-de-France

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• Coordinating investigator:  Pr Olivier HANON, AP-HP

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• Promoter: Gérond'if

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• Funding : Gérond'if

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Night IDE study in EHPAD

(in progress)

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• 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.

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• 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.  

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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.  

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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.

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• 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    

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• Promoters : ARS Ile-de-France, Gérond'if

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• 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