Informations générales (source: ClinicalTrials.gov)
Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
Observational [Patient Registry]
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
avril 2022
décembre 2023
08 septembre 2025
Background:
Elderly people with serious haemophilia (PwSH), i.e., with moderate or severe
haemophilia, have major comorbidities due to consequences of haemophilia. Also, the
comorbidities related to age are added. Despite the existence of numerous studies on the
objective health status of elderly PwSH, some limitations may be stated (need to update
the results in a more contemporary context, no studies conducted in France, highlighted
determinants focused on demographic and clinical factors).
On the contrary, the perceived health status of elderly PwSH has been little described.
Only two studies specifically addressed the quality of life (QoL) of elderly PwSH. These
studies reported an altered QoL in some domains, in comparison with reference values from
the general population. However, some limitations may also be stated (need to bring
results in a more contemporary context, no studies conducted in France, highlighted
determinants focused on clinical factors).
Since serious haemophilia is a rare disease, studies are often performed on a small
number of subjects. The present project relies on the FranceCoag registry, a unique
exhaustive national cohort of PwSH followed over time among whom 612 are elderly PwSH.
Objectives:
Main objective: to describe the objective and perceived health status of elderly (≥60
y.o.) PwSH from of a French exhaustive national registry, and to compare their health
status with that of the French general elderly population.
Secondary objective: to identify individual (demographic, clinical, social,
psycho-cognitive) and collective characteristics (related to healthcare organisation),
associated with the objective and perceived health status of elderly PwSH in France.
Materials and Methods:
A national, multicentric, observational, cross-sectional study will be conducted. It will
be based on the participation of elderly PwSH already included in the FranceCoag
registry. Each eligible participant will receive a questionnaire to complete concerning:
objective health status; perceived health status (QoL assessed by the WHOQOL-Old
questionnaire); demographic data; social data; psycho-cognitive data (anxious symptoms,
depressive symptoms, use of coping strategies, time perspective). Therapeutic and
clinical data related to haemophilia will be collected via the FranceCoag registry
database. Data concerning healthcare organisation will be collected directly from
investigators of Haemophilia Treatment Centres.
The main analysis will consist in the description and comparison of the health status
with reference data from the French general elderly population. Standardisation methods
will be used to take into account a potential imbalance between the study population and
the reference population, related to age and especially to sex, as haemophilia is a
predominantly male disease.
The secondary analysis will consist in the identification of potential determinants of
the health status. Structural equation models will be performed to take into account the
complexity of the relationships between the determinants.
Impact of the proposal Better understanding the impact of the disease on patients'
experience is essential in a systematic global perspective of health, that aims to care
and support the individual not only as a patient but also as a person in his/her
environment. This study based on a registry will allow to improve the knowledge by
updating literature data on the health status of elderly PwSH, adding elements to the
rare literature data on the perceived health status, providing data in the French
specific context, and identifying both classical and more original determinants of health
status of elderly PwSH. These results will be used to better identify elderly PwSH at
high risk of poor health status, to propose recommendations and to set up actions to
offer them an adapted support, and to elaborate new versions of public health plans
dedicated to haemophilia or to rare diseases.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | Emmanuelle DE RAUCOURT | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ap-Hm - 13005 - Marseille - France | Noemie Resseguier | Contact (sur clinicalTrials) | |||
| AP-HP - Paris - France | na na | Contact (sur clinicalTrials) | |||
| Centre hospitalier Métropole Savoie - Chambery - France | Valerie GAY | Contact (sur clinicalTrials) | |||
| Ch Annecy - St Julien - Annecy - France | Claire REYNES | Contact (sur clinicalTrials) | |||
| Chru de Lille - Lille - France | Antoine RAUCH | Contact (sur clinicalTrials) | |||
| Chru de Tours - Tours - France | Laurent ARDILLON | Contact (sur clinicalTrials) | |||
| Chu Amiens - Amiens - France | Annelise VOYER | Contact (sur clinicalTrials) | |||
| Chu Brest - Brest - France | Brigitte PAN-PETESCH | Contact (sur clinicalTrials) | |||
| Chu Clermont-Ferrand - Clermont-Ferrand - France | Aurelien LEBRETON | Contact (sur clinicalTrials) | |||
| Chu de Besancon - Besançon - France | Alexandra FOURNEL | Contact (sur clinicalTrials) | |||
| Chu de Bordeaux - Bordeaux - France | Sabine-Marie CASTET | Contact (sur clinicalTrials) | |||
| Chu de Caen - Caen - France | Yohann REPESSE | Contact (sur clinicalTrials) | |||
| Chu de Dijon - Dijon - France | Fabienne GENRE VOLOT | Contact (sur clinicalTrials) | |||
| Chu de Nancy - Nancy - France | Birgit FROTSCHER | Contact (sur clinicalTrials) | |||
| Chu de Nice - Nice - France | Pierre-Simon ROHRLICH | Contact (sur clinicalTrials) | |||
| Chu de Rennes - Rennes - France | Benoît GUILLET | Contact (sur clinicalTrials) | |||
| Chu de Rouen - Rouen - France | Pierre CHAMOUNI | Contact (sur clinicalTrials) | |||
| Chu La Reunion - La Réunion - France | Stephane VANDERBECKEN | Contact (sur clinicalTrials) | |||
| Chu Le Mans - Le Mans - France | Vincent CUSSAC | Contact (sur clinicalTrials) | |||
| Chu Montpellier - Montpellier - France | Christine BIRON-ANDREANI | Contact (sur clinicalTrials) | |||
| Chu Nantes - Nantes - France | Marc TROSSAËRT | Contact (sur clinicalTrials) | |||
| Chu Poitiers - Poitiers - France | Mathieu PUYADE | Contact (sur clinicalTrials) | |||
| Chu Reims - Reims - France | Philippe NGUYEN | Contact (sur clinicalTrials) | |||
| Chu St Etienne - Saint-Étienne - France | Brigitte TARDY | Contact (sur clinicalTrials) | |||
| Chu Strasbourg - Strasbourg - France | Dominique DESPREZ | Contact (sur clinicalTrials) | |||
| Chu Toulouse - Toulouse - France | Marie-Lea PIEL-JULIAN | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Lyon - France | Anne LIENHART | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- People with serious haemophilia, i.e., with (A or B) moderate or severe haemophilia;
- People aged 60 years or over;
- People included in the FranceCoag registry;
- People followed in one of the Haemophilia Treatment Centre participating in the
study;
- People who do not oppose to participate in the study.
- People with serious haemophilia, i.e., with (A or B) moderate or severe haemophilia;
- People aged 60 years or over;
- People included in the FranceCoag registry;
- People followed in one of the Haemophilia Treatment Centre participating in the
study;
- People who do not oppose to participate in the study.
- People with comprehension disabilities;
- Participants who a posteriori oppose to participate in the study.