Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
NCT ID: NCT05218772
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
612 participants
OBSERVATIONAL
2022-04-19
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Elderly people with moderate or severe haemophilia
Questionnaires
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)
Interventions
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Questionnaires
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)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Participants who a posteriori oppose to participate in the study.
60 Years
100 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Locations
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Chu Amiens
Amiens, , France
Ch Annecy - St Julien
Annecy, , France
Chu de Besancon
Besançon, , France
Chu de Bordeaux
Bordeaux, , France
Chu Brest
Brest, , France
Chu de Caen
Caen, , France
Centre hospitalier Métropole Savoie
Chambéry, , France
Chu Clermont-Ferrand
Clermont-Ferrand, , France
Chu de Dijon
Dijon, , France
Chu La Reunion
La Réunion, , France
Chu Le Mans
Le Mans, , France
Chru de Lille
Lille, , France
Hospices Civils de Lyon
Lyon, , France
Ap-Hm
Marseille, , France
Chu Montpellier
Montpellier, , France
Chu de Nancy
Nancy, , France
Chu Nantes
Nantes, , France
Chu de Nice
Nice, , France
AP-HP
Paris, , France
Chu Poitiers
Poitiers, , France
Chu Reims
Reims, , France
Chu de Rennes
Rennes, , France
Chu de Rouen
Rouen, , France
Chu St Etienne
Saint-Etienne, , France
Chu Strasbourg
Strasbourg, , France
Chu Toulouse
Toulouse, , France
Chru de Tours
Tours, , France
Ch Versailles
Versailles, , France
Countries
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Central Contacts
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Facility Contacts
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Annelise VOYER
Role: primary
Claire REYNES
Role: primary
Alexandra FOURNEL
Role: primary
Sabine-Marie CASTET
Role: primary
Brigitte PAN-PETESCH
Role: primary
Yohann REPESSE
Role: primary
Valerie GAY
Role: primary
Aurelien LEBRETON
Role: primary
Fabienne GENRE VOLOT
Role: primary
Stephane VANDERBECKEN
Role: primary
Vincent CUSSAC
Role: primary
Antoine RAUCH
Role: primary
Anne LIENHART
Role: primary
Noemie Resseguier
Role: primary
Christine BIRON-ANDREANI
Role: primary
Birgit FROTSCHER
Role: primary
Marc TROSSAËRT
Role: primary
Pierre-Simon ROHRLICH
Role: primary
na na
Role: primary
Mathieu PUYADE
Role: primary
Philippe NGUYEN
Role: primary
Benoît GUILLET
Role: primary
Pierre CHAMOUNI
Role: primary
Brigitte TARDY
Role: primary
Dominique DESPREZ
Role: primary
Marie-Lea PIEL-JULIAN
Role: primary
Laurent ARDILLON
Role: primary
Emmanuelle DE RAUCOURT
Role: primary
Other Identifiers
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2021-20
Identifier Type: -
Identifier Source: org_study_id
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