Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218772
Status:
RECRUITING
Last Update Posted:
2023-06-08
First Post:
2022-01-20
Brief Title:
Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France an Ancillary Study of the FranceCoag Registry
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France an Ancillary Study of the FranceCoag Registry
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENIORHEMO
Brief Summary:
Background
Elderly people with serious haemophilia PwSH ie 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 yo 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 hisher 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
Elderly people with serious haemophilia PwSH ie 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 yo 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 hisher 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None