HaemophiliaNCT03054662
Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.
A study testing Education, Improve biological diagnosis and follow-up of haemophilia and Implement haemostatic non substitutive care of haemophilia in people with Haemophilia and Developing Countries, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Côte d’Ivoire.
Trial summary
This study aims to make an inventory of the condition and care of patients with haemophilia and carriers for haemophilia in Ivory Coast and to promote the use non substitutive strategies that are not costly and available in Ivory Coast, to improve the management of haemophilia in this country. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Haemophilia, Developing Countries
- What is being tested?
- Education, Improve biological diagnosis and follow-up of haemophilia and Implement haemostatic non substitutive care of haemophilia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 16 Jan 2017to 17 Sep 2019
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males with severe and moderate haemophilia A and B in Ivory Coast (any age).
- Females over 12 years who are carriers for severe and moderate haemophilia A and B in Ivory Coast.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to make an inventory of the condition and care of patients with haemophilia and carriers for haemophilia in Ivory Coast and to promote the use non substitutive strategies that are not costly and available in Ivory Coast, to improve the management of haemophilia in this country. The purpose of this project is to evaluate the extent to which the active promotion of these various measures will improve the care of patients with haemophilia and carriers in Ivory Coast.
Read the detailed description
- Establish a baseline of the condition of haemophilia in Ivory Coast (number of patients, demographics, reassessment of diagnosis, joint status...).(year 1)
- Develop tools to assess the intervention (eg transcultural validation of QoL questionnaires, develop booklets to record bleedings...). (year 1)
- Intervention phase that will focus on education of patients and their family, education of caregivers, training of the laboratory to the diagnosis of haemophilia and promotion of non substitutive strategies to improve haemophilia care in Ivory Coast (DDAVP, antifibrinolytics, physiotherapy, dental care,...).
- Follow-up phase during 2 years.
- Outcome analysis
- Conditions
- Haemophilia, Developing Countries
- Being tested
- Education, Improve biological diagnosis and follow-up of haemophilia, Implement haemostatic non substitutive care of haemophilia, Implement non haemostatic care of haemophilia
- Keywords
- Haemophilia
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Education of patients and caregivers about haemophilia and carriers of haemophilia.
Improve biological diagnosis and follow-up of haemophiliaDiagnostic test
train the laboratory to the diagnosis ans follow-up un haemophilia
Implement haemostatic non substitutive care of haemophiliaDrug
Implement the use of DDAVP and antifibrinolytics in patients with haemophilia and symptomatic carriers
Implement non haemostatic care of haemophiliaOther
Also called Physiotherapy, dental care, pain killers
Implement regular physiotherapy, develop dental care, promote the regular use of pain killers
| Study group | Role | What they receive |
|---|---|---|
| Patients with Haemophilia | Experimental | Male patients with severe and moderate haemophilia A and B in Ivory Coast Receives: Other: Education; Diagnostic Test: Improve biological diagnosis and follow-up of haemophilia; Drug: Implement haemostatic non substitutive care of haemophilia; Other: Implement non haemostatic care of haemophilia |
| Carriers for Haemophilia | Experimental | Carriers for severe and moderate haemophilia A and B in Ivory Coast Receives: Other: Education; Diagnostic Test: Improve biological diagnosis and follow-up of haemophilia; Drug: Implement haemostatic non substitutive care of haemophilia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve haemophilia care in Ivory Coast
Compare QoL questionnaires before and after the intervention phase
Measured: 2 years after intervention
Improve haemophilia diagnosis of haemophilia in Ivory Coast
Compare the number of patients with haemophilia between the beginning and the end of the study
Measured: 3 years
Improve haemophilia care in Ivory Coast
Compare the pain assessment before and after the intervention phase
Measured: 2 years after intervention
Improve knowledge about haemophilia in Ivory Coast
Compare the knowledge queestionnaires about haemophilia before and after the intervention phase
Measured: 2 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start16 Jan 2017
- Primary completion31 Dec 2018
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- monocentric prospective study with longitudinal data collection of a single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- World Federation of Hemophilia
- Responsible party
- Sponsor
- Investigators
- Catherine M Lambert, MD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054662
- Sponsor's protocol ID
- 002/MSHP/CNER-kp
- Status last verified
- Sep 2019
- First submitted
- 13 Feb 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.
- ClinicalTrials.gov ID
- NCT03054662
- Acronym / sponsor ID
- 002/MSHP/CNER-kp
- Conditions
- Haemophilia, Developing Countries
- Keywords
- Haemophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- World Federation of Hemophilia
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 15 Feb 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.
This study aims to make an inventory of the condition and care of patients with haemophilia and carriers for haemophilia in Ivory Coast and to promote the use non substitutive strategies that are not costly and available in Ivory Coast, to improve the management of haemophilia in this country. The purpose of this project is to evaluate the extent to which the active promotion of these various measures will improve the care of patients with haemophilia and carriers in Ivory Coast.
Detailed description
- Establish a baseline of the condition of haemophilia in Ivory Coast (number of patients, demographics, reassessment of diagnosis, joint status...).(year 1)
- Develop tools to assess the intervention (eg transcultural validation of QoL questionnaires, develop booklets to record bleedings...). (year 1)
- Intervention phase that will focus on education of patients and their family, education of caregivers, training of the laboratory to the diagnosis of haemophilia and promotion of non substitutive strategies to improve haemophilia care in Ivory Coast (DDAVP, antifibrinolytics, physiotherapy, dental care,...).
- Follow-up phase during 2 years.
- Outcome analysis
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric prospective study with longitudinal data collection of a single group
| Arm | Type | Receives |
|---|---|---|
| Patients with Haemophilia | Experimental | Other: Education, Diagnostic Test: Improve biological diagnosis and follow-up of haemophilia, Drug: Implement haemostatic non substitutive care of haemophilia, Other: Implement non haemostatic care of haemophiliaMale patients with severe and moderate haemophilia A and B in Ivory Coast |
| Carriers for Haemophilia | Experimental | Other: Education, Diagnostic Test: Improve biological diagnosis and follow-up of haemophilia, Drug: Implement haemostatic non substitutive care of haemophiliaCarriers for severe and moderate haemophilia A and B in Ivory Coast |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Males with severe and moderate haemophilia A and B in Ivory Coast (any age).
- Females over 12 years who are carriers for severe and moderate haemophilia A and B in Ivory Coast.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EducationEducation of patients and caregivers about haemophilia and carriers of haemophilia. | Other | Carriers for Haemophilia, Patients with Haemophilia |
| Improve biological diagnosis and follow-up of haemophiliatrain the laboratory to the diagnosis ans follow-up un haemophilia | Diagnostic test | Carriers for Haemophilia, Patients with Haemophilia |
| Implement haemostatic non substitutive care of haemophiliaImplement the use of DDAVP and antifibrinolytics in patients with haemophilia and symptomatic carriers | Drug | Carriers for Haemophilia, Patients with Haemophilia |
| Implement non haemostatic care of haemophiliaAlso: Physiotherapy, dental care, pain killersImplement regular physiotherapy, develop dental care, promote the regular use of pain killers | Other | Patients with Haemophilia |
Primary outcome
Improve haemophilia care in Ivory Coast
Time frame: 2 years after intervention
Compare QoL questionnaires before and after the intervention phase
Improve haemophilia diagnosis of haemophilia in Ivory Coast
Time frame: 3 years
Compare the number of patients with haemophilia between the beginning and the end of the study
Improve haemophilia care in Ivory Coast
Time frame: 2 years after intervention
Compare the pain assessment before and after the intervention phase
Improve knowledge about haemophilia in Ivory Coast
Time frame: 2 years after intervention
Compare the knowledge queestionnaires about haemophilia before and after the intervention phase
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 27 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Catherine M Lambert, MD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Improve biological diagnosis and follow-up of haemophilia and Implement haemostatic non substitutive care of haemophilia in people with Haemophilia and Developing Countries, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Côte d’Ivoire.
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 2 inclusion and 0 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 27 Sep 2019. 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 Côte d’Ivoire. 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?
Improve haemophilia care in Ivory Coast (time frame: 2 years after intervention). The study lists 4 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 27 Sep 2019.