Severe HaemophiliaINTHEMONCT03301376
Occupational Integration of Adults With Severe Haemophilia in France: a Study Based on the FranceCoag Cohort
An observational study of Severe Haemophilia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired health-related quality of life. Improvements in haemophilia care over the last decades might lead to expectation of a near-normal quality of life for adults with haemophilia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Haemophilia
- How many people
- 590 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 27 May 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with severe haemophilia
Who may be able to join
- Patients with severe haemophilia
- Patients aged from 18 to 65 years old
- Patients enrolled in the FranceCoag national cohort
- Patients affiliated to the French social security system
- Non opposition to participate in the study
Who cannot join
- Patients with moderate or minor haemophilia
- Patients under the age of 18 or over the age of 65
- Patients with comprehension problems
- Patients unable to read or to write
- Vulnerable patients
- Opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, 13354
About this study
Official title: INTHEMO: Occupational Integration of Adults With Severe Haemophilia in France: a Study Based on the FranceCoag Cohort
Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired health-related quality of life. Improvements in haemophilia care over the last decades might lead to expectation of a near-normal quality of life for adults with haemophilia. However, little is known about the impact of haemophilia and its treatment on social functioning. A study based on a national US cohort of 141 young men (18-34 y.o.) showed that, compared to the general US population, this cohort experienced social burdens such as unemployment and lower high-school graduation rates. Another study conducted in the framework of the HERO (Haemophilia Experiences, Results and Opportunities) international initiative showed that a majority of the 230 young adults aged 18-30 years (including 16 French participants) were employed at least part-time (62%) and most of them reported that haemophilia has had a negative impact on employment (76%) which was reported as moderate or very large by 47% of the participants. The replicability of these results could be limited by the specific socio-economic national context. In France, a survey was conducted in 2008 to assess quality of life and its determinants in children, adolescents and adults with moderate and severe haemophilia. Descriptive results on the socio-economic characteristics of the included adults showed that 51.3% of them had access to higher education (which was higher than the observed rate in the French general population in 2005, i.e. 32.5%), and that 52.1% were employed among whom 44.3% had an at-risk activity. In spite of these results which were presented in a descriptive report by the InVS (Institut de veille sanitaire - French Institute for Public Health Surveillance), some limitations could be discussed:
Read the detailed description
The principal objective of the present project is to assess occupational issues in an exhaustive national cohort of persons with severe haemophilia compared to the national population in order to describe the impact of severe haemophilia on the occupational integration.
Detailed objectives are mentioned hereinbelow:
- To assess occupational issues in adults with severe haemophilia in France
- To assess the impact of the changes of the context of life over the last decades in the new generation of adults with severe haemophilia in France
- To compare occupational outcomes between adults with severe haemophilia and the general population in France
- To identify individual characteristics (socio-demographics, clinical and psycho-behavioural) associated with occupational issues in adults with severe haemophilia in France
- To compare occupational issues between adults with severe haemophilia and adults with others severe chronic childhood diseases in France to identify common and haemophilia-specific issues
Material and methods:
All adults (18-65 y.o.) participating in the FranceCoag cohort, which includes more than 1,500 French adults with severe haemophilia followed-up in 34 Haemophilia Treatment Centres, will be invited to participate in the study. These adults will be identified through the database of the FranceCoag cohort, and will be invited to participate through the post by the physician who follows them up in the Haemophilia Treatment Centre. If they agree to participate, they will be asked to fill a self-administered questionnaire in. This questionnaire will include items focusing on the following outcomes:
- occupational outcomes:
- access to higher education and high-school graduation,
- age at the start of working life,
- degree of employment (unemployment / part-time employment / full-time employment),
- sheltered employment,
- job security (temporary / permanent contract / self-employment),
- type of job (using the International Standard Classification of Occupations)
- socio-demographic outcomes:
- age
- living with a partner
- having dependent children
- psycho-behavioural outcomes:
- depressive symptomatology (using the Center for Epidemiologic Studies Depression (CES-D) scale)
- quality of life (using the generic scale 36-Item Short Form Survey (SF-12) and the haemophilia-specific scale Haem-A-QoL)
- anxiety (using the Strate-Trait Anxiety Inventory (STAI) scale)
- coping strategies (using the BriefCOPE)
- perceived impact of haemophilia on employment
- participating in therapeutic education sessions
- member of the Association française des hémophiles (AFH)
Clinical outcomes will be recorded via the FranceCoag cohort database (type of haemophilia, treatment, presence of an inhibitor, comorbidities as HIV and HCV infections).
Occupational outcomes of the participants will be described, and compared to the French national population. Expected distributions of the outcomes will be established by using data from the French National Institute for Statistics and Economic Studies. Observed and expected distributions will be compared. The modulating role of individual characteristics (including the period of birth, the presence of an inhibitor, comorbidities as HIV and HCV infections) in occupational issues will be assessed.
Expected results:
The results of this project will establish an updated picture of the occupational situation of French adults with severe haemophilia. By comparing the evolution of the occupational situation among them with the evolution in adults from the general population, the investigators will be able to assess the possibly different impact of the changes of the socio-economic context on the occupational situation of adults with severe haemophilia. The results will also establish a new picture of the occupational situation for the new generation of adults who was not concerned by the survey carried out about ten years ago. This sub-group is of particular interest as the impact of the disease on their life might have been different (major therapeutic progresses, no exposition to transfusion-transmitted infections).
Via the French haemophilia society (AFH) which is a partner of the present project, the results from the objectives 1 to 4 will be used for the education, training and awareness of patient resources, for the development of therapeutic patient education sessions focused on occupational issues, and for the drawing up of a brochure intended for patients.
Survivors of childhood leukemia from the French LEA cohort who present a higher rate of employment than the general population, but a lower access to a steady job could be an interesting comparative group for the fifth objective. As numerous actions are proposed to facilitate the occupational integration of survivors of cancer, the identification of the haemophilia-specific difficulties could help the decisions-makers to allocate means according to the specific needs of the persons with haemophilia.
- Conditions
- Severe Haemophilia
- Medical subject headings
- Hemophilia A
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of employment
unemployment / part-time employment / full-time employment
Measured: one day
Secondary outcomes (4)
Access to higher education and high-school graduation
Specific item of the patient questionnaire (yes(type)/no)
Measured: one day
Age at the start of working life
Specific item of the patient questionnaire (age(years))
Measured: one day
Sheltered employment
Specific item of the patient questionnaire (yes(type)/no)
Measured: one day
Job security
Specific item of the patient questionnaire (temporary / permanent contract / self-employment)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start28 Aug 2018
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301376
- Sponsor's protocol ID
- 2016-51
- Acronym
- INTHEMO
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTHEMO: Occupational Integration of Adults With Severe Haemophilia in France: a Study Based on the FranceCoag Cohort
- ClinicalTrials.gov ID
- NCT03301376
- Acronym / sponsor ID
- INTHEMO / 2016-51
- Conditions
- Severe Haemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 4 Oct 2017 (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.
Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired health-related quality of life. Improvements in haemophilia care over the last decades might lead to expectation of a near-normal quality of life for adults with haemophilia. However, little is known about the impact of haemophilia and its treatment on social functioning. A study based on a national US cohort of 141 young men (18-34 y.o.) showed that, compared to the general US population, this cohort experienced social burdens such as unemployment and lower high-school graduation rates. Another study conducted in the framework of the HERO (Haemophilia Experiences, Results and Opportunities) international initiative showed that a majority of the 230 young adults aged 18-30 years (including 16 French participants) were employed at least part-time (62%) and most of them reported that haemophilia has had a negative impact on employment (76%) which was reported as moderate or very large by 47% of the participants. The replicability of these results could be limited by the specific socio-economic national context. In France, a survey was conducted in 2008 to assess quality of life and its determinants in children, adolescents and adults with moderate and severe haemophilia. Descriptive results on the socio-economic characteristics of the included adults showed that 51.3% of them had access to higher education (which was higher than the observed rate in the French general population in 2005, i.e. 32.5%), and that 52.1% were employed among whom 44.3% had an at-risk activity. In spite of these results which were presented in a descriptive report by the InVS (Institut de veille sanitaire - French Institute for Public Health Surveillance), some limitations could be discussed:
Detailed description
The principal objective of the present project is to assess occupational issues in an exhaustive national cohort of persons with severe haemophilia compared to the national population in order to describe the impact of severe haemophilia on the occupational integration.
Detailed objectives are mentioned hereinbelow:
- To assess occupational issues in adults with severe haemophilia in France
- To assess the impact of the changes of the context of life over the last decades in the new generation of adults with severe haemophilia in France
- To compare occupational outcomes between adults with severe haemophilia and the general population in France
- To identify individual characteristics (socio-demographics, clinical and psycho-behavioural) associated with occupational issues in adults with severe haemophilia in France
- To compare occupational issues between adults with severe haemophilia and adults with others severe chronic childhood diseases in France to identify common and haemophilia-specific issues
Material and methods:
All adults (18-65 y.o.) participating in the FranceCoag cohort, which includes more than 1,500 French adults with severe haemophilia followed-up in 34 Haemophilia Treatment Centres, will be invited to participate in the study. These adults will be identified through the database of the FranceCoag cohort, and will be invited to participate through the post by the physician who follows them up in the Haemophilia Treatment Centre. If they agree to participate, they will be asked to fill a self-administered questionnaire in. This questionnaire will include items focusing on the following outcomes:
- occupational outcomes:
- access to higher education and high-school graduation,
- age at the start of working life,
- degree of employment (unemployment / part-time employment / full-time employment),
- sheltered employment,
- job security (temporary / permanent contract / self-employment),
- type of job (using the International Standard Classification of Occupations)
- socio-demographic outcomes:
- age
- living with a partner
- having dependent children
- psycho-behavioural outcomes:
- depressive symptomatology (using the Center for Epidemiologic Studies Depression (CES-D) scale)
- quality of life (using the generic scale 36-Item Short Form Survey (SF-12) and the haemophilia-specific scale Haem-A-QoL)
- anxiety (using the Strate-Trait Anxiety Inventory (STAI) scale)
- coping strategies (using the BriefCOPE)
- perceived impact of haemophilia on employment
- participating in therapeutic education sessions
- member of the Association française des hémophiles (AFH)
Clinical outcomes will be recorded via the FranceCoag cohort database (type of haemophilia, treatment, presence of an inhibitor, comorbidities as HIV and HCV infections).
Occupational outcomes of the participants will be described, and compared to the French national population. Expected distributions of the outcomes will be established by using data from the French National Institute for Statistics and Economic Studies. Observed and expected distributions will be compared. The modulating role of individual characteristics (including the period of birth, the presence of an inhibitor, comorbidities as HIV and HCV infections) in occupational issues will be assessed.
Expected results:
The results of this project will establish an updated picture of the occupational situation of French adults with severe haemophilia. By comparing the evolution of the occupational situation among them with the evolution in adults from the general population, the investigators will be able to assess the possibly different impact of the changes of the socio-economic context on the occupational situation of adults with severe haemophilia. The results will also establish a new picture of the occupational situation for the new generation of adults who was not concerned by the survey carried out about ten years ago. This sub-group is of particular interest as the impact of the disease on their life might have been different (major therapeutic progresses, no exposition to transfusion-transmitted infections).
Via the French haemophilia society (AFH) which is a partner of the present project, the results from the objectives 1 to 4 will be used for the education, training and awareness of patient resources, for the development of therapeutic patient education sessions focused on occupational issues, and for the drawing up of a brochure intended for patients.
Survivors of childhood leukemia from the French LEA cohort who present a higher rate of employment than the general population, but a lower access to a steady job could be an interesting comparative group for the fifth objective. As numerous actions are proposed to facilitate the occupational integration of survivors of cancer, the identification of the haemophilia-specific difficulties could help the decisions-makers to allocate means according to the specific needs of the persons with haemophilia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with severe haemophilia
Key inclusion criteria (5 listed)
- Patients with severe haemophilia
- Patients aged from 18 to 65 years old
- Patients enrolled in the FranceCoag national cohort
- Patients affiliated to the French social security system
- Non opposition to participate in the study
Key exclusion criteria (6 listed)
- Patients with moderate or minor haemophilia
- Patients under the age of 18 or over the age of 65
- Patients with comprehension problems
- Patients unable to read or to write
- Vulnerable patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of employment
Time frame: one day
unemployment / part-time employment / full-time employment
4 secondary outcomes
Access to higher education and high-school graduation
Time frame: one day
Age at the start of working life
Time frame: one day
Sheltered employment
Time frame: one day
Job security
Time frame: one day
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 15 Feb 2023.
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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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Haemophilia, run by Assistance Publique Hopitaux De Marseille at 1 site 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 6 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Degree of employment (time frame: one day). 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 15 Feb 2023.