Clinical trial NCT05218772: Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
Official title: Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Moderate or Serious Haemophilia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 612
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people with moderate or severe haemophilia in France

Brief summary: 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.


Eligibility criteria: 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.

Exclusion Criteria:

* People with comprehension disabilities;
* Participants who a posteriori oppose to participate in the study.

Primary outcomes:
measure: Objective health status (apart from serious haemophilia)
timeFrame: 1 day
measure: Perceived health status
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Annecy
country: France
facility: Ch Annecy - St Julien
city: Besançon
country: France
facility: Chu de Besancon
city: Bordeaux
country: France
facility: Chu de Bordeaux
city: Brest
country: France
facility: Chu Brest
city: Caen
country: France
facility: Chu de Caen
city: Chambery
country: France
facility: Centre hospitalier Métropole Savoie
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Dijon
country: France
facility: Chu de Dijon
city: La Réunion
country: France
facility: Chu La Reunion
city: Le Mans
country: France
facility: Chu Le Mans
city: Lille
country: France
facility: Chru de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Ap-Hm
city: Montpellier
country: France
facility: Chu Montpellier
city: Nancy
country: France
facility: Chu de Nancy
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: Chu de Nice
city: Paris
country: France
facility: AP-HP
city: Poitiers
country: France
facility: Chu Poitiers
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Chu de Rennes
city: Rouen
country: France
facility: Chu de Rouen
city: Saint-Étienne
country: France
facility: Chu St Etienne
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: Chru de Tours
city: Versailles
country: France
facility: Ch Versailles
Study officials:
References: