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Trial record 8 of 41 for:    Diseases | ( Map: Côte D'Ivoire )

Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.

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ClinicalTrials.gov Identifier: NCT03054662
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
World Federation of Hemophilia
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Haemophilia Developing Countries 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 Not Applicable

Detailed Description:
  1. Establish a baseline of the condition of haemophilia in Ivory Coast (number of patients, demographics, reassessment of diagnosis, joint status...).(year 1)
  2. Develop tools to assess the intervention (eg transcultural validation of QoL questionnaires, develop booklets to record bleedings...). (year 1)
  3. 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,...).
  4. Follow-up phase during 2 years.
  5. Outcome analysis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: monocentric prospective study with longitudinal data collection of a single group
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with Haemophilia
Male patients with severe and moderate haemophilia A and B in Ivory Coast
Other: Education
Education of patients and caregivers about haemophilia and carriers of haemophilia.

Diagnostic Test: Improve biological diagnosis and follow-up of haemophilia
train the laboratory to the diagnosis ans follow-up un haemophilia

Drug: Implement haemostatic non substitutive care of haemophilia
Implement the use of DDAVP and antifibrinolytics in patients with haemophilia and symptomatic carriers

Other: Implement non haemostatic care of haemophilia
Implement regular physiotherapy, develop dental care, promote the regular use of pain killers
Other Name: Physiotherapy, dental care, pain killers

Experimental: Carriers for Haemophilia
Carriers for severe and moderate haemophilia A and B in Ivory Coast
Other: Education
Education of patients and caregivers about haemophilia and carriers of haemophilia.

Diagnostic Test: Improve biological diagnosis and follow-up of haemophilia
train the laboratory to the diagnosis ans follow-up un haemophilia

Drug: Implement haemostatic non substitutive care of haemophilia
Implement the use of DDAVP and antifibrinolytics in patients with haemophilia and symptomatic carriers




Primary Outcome Measures :
  1. Improve haemophilia care in Ivory Coast [ Time Frame: 2 years after intervention ]
    Compare QoL questionnaires before and after the intervention phase

  2. 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

  3. Improve haemophilia care in Ivory Coast [ Time Frame: 2 years after intervention ]
    Compare the pain assessment before and after the intervention phase

  4. 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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Exclusion Criteria: subjects not willing to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054662


Contacts
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Contact: Catherine M Lambert, MD +32-2-764.17.08 catherine.lambert@uclouvain.be
Contact: Cedric R Hermans, MD, PhD +32-2-764.17.85 cedric.hermans@uclouvain.be

Locations
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Côte D'Ivoire
CHU de Yopougon Recruiting
Abidjan, Côte D'Ivoire
Contact: Ibrahima Sanogo, MD    +225-07918225    ibesan@yahoo.fr   
Contact: Meité N'Dogomo, MD    +225-07918225    n_meite@yahoo.fr   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
World Federation of Hemophilia
Investigators
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Study Director: Catherine M Lambert, MD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03054662     History of Changes
Other Study ID Numbers: 002/MSHP/CNER-kp
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Haemophilia

Additional relevant MeSH terms:
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Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hemophilia A
Hemostatics
Analgesics
Coagulants
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs