Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
SENIORHEMO
1 other identifier
observational
612
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
28 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedStudy Start
First participant enrolled
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 8, 2023
June 1, 2023
1.2 years
January 20, 2022
June 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Objective health status (apart from serious haemophilia)
Declaration by the participant of at least one chronic disease or health issue (apart from serious haemophilia)
1 day
Perceived health status
Assessed by the quality of life, which will be measured by the WHOQOL-Old questionnaire
1 day
Study Arms (1)
Elderly people with moderate or severe haemophilia
Interventions
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
Elderly people with moderate or severe haemophilia in France
You may qualify if:
- 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.
You may not qualify if:
- People with comprehension disabilities;
- Participants who a posteriori oppose to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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, 13005, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2022
First Posted
February 1, 2022
Study Start
April 19, 2022
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
June 8, 2023
Record last verified: 2023-06