Moderate or Serious HaemophiliaSENIORHEMONCT05218772
Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
An observational study of Moderate or Serious Haemophilia, run by Assistance Publique Hopitaux De Marseille at 28 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Moderate or Serious Haemophilia
- What is being tested?
- Questionnaires
- How many people
- 277 participants
- Where
- 28 sitesFrance
- Study dates
- 19 Apr 2022to 1 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly people with moderate or severe haemophilia in France
Who may be able to join
- 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.
Who cannot join
- People with comprehension disabilities;
- Participants who a posteriori oppose to participate in the study.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
Chu Amiens
Amiens
Ch Annecy - St Julien
Annecy
Chu de Besancon
Besançon
Chu de Bordeaux
Bordeaux
Chu Brest
Brest
Chu de Caen
Caen
Centre hospitalier Métropole Savoie
Chambéry
Chu Clermont-Ferrand
Clermont-Ferrand
Chu de Dijon
Dijon
Chu La Reunion
La Réunion
Chu Le Mans
Le Mans
Chru de Lille
Lille
Hospices Civils de Lyon
Lyon
Ap-Hm
Marseille, 13005
Chu Montpellier
Montpellier
Chu de Nancy
Nancy
Chu Nantes
Nantes
Chu de Nice
Nice
AP-HP
Paris
Chu Poitiers
Poitiers
Chu Reims
Reims
Chu de Rennes
Rennes
Chu de Rouen
Rouen
Chu St Etienne
Saint-Etienne
Chu Strasbourg
Strasbourg
Chu Toulouse
Toulouse
Chru de Tours
Tours
Ch Versailles
Versailles
About this study
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).
Read more
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.
- Conditions
- Moderate or Serious Haemophilia
- Being tested
- Questionnaires
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Elderly people with moderate or severe haemophilia | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective health status (apart from serious haemophilia)
Declaration by the participant of at least one chronic disease or health issue (apart from serious haemophilia)
Measured: 1 day
Perceived health status
Assessed by the quality of life, which will be measured by the WHOQOL-Old questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start19 Apr 2022
- Primary completion30 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate or Serious HaemophiliaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 277 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218772
- Sponsor's protocol ID
- 2021-20
- Acronym
- SENIORHEMO
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry
- ClinicalTrials.gov ID
- NCT05218772
- Acronym / sponsor ID
- SENIORHEMO / 2021-20
- Conditions
- Moderate or Serious Haemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly people with moderate or severe haemophilia | – | Other: Questionnaires |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly people with moderate or severe haemophilia in France
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- People with comprehension disabilities;
- Participants who a posteriori oppose to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesEach 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) | Other | Elderly people with moderate or severe haemophilia |
Primary outcome
Objective health status (apart from serious haemophilia)
Time frame: 1 day
Declaration by the participant of at least one chronic disease or health issue (apart from serious haemophilia)
Perceived health status
Time frame: 1 day
Assessed by the quality of life, which will be measured by the WHOQOL-Old questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate or Serious Haemophilia, run by Assistance Publique Hopitaux De Marseille at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective health status (apart from serious haemophilia) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.