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

Haemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054662
• Other study ID #: 002/MSHP/CNER-kp
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 17, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Developing Countries
• Haemophilia
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
Côte D'Ivoire	CHU de Yopougon	Abidjan

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	World Federation of Hemophilia

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve haemophilia care in Ivory Coast	Compare QoL questionnaires before and after the intervention phase	2 years after intervention
Primary	Improve haemophilia diagnosis of haemophilia in Ivory Coast	Compare the number of patients with haemophilia between the beginning and the end of the study	3 years
Primary	Improve haemophilia care in Ivory Coast	Compare the pain assessment before and after the intervention phase	2 years after intervention
Primary	Improve knowledge about haemophilia in Ivory Coast	Compare the knowledge queestionnaires about haemophilia before and after the intervention phase	2 years after intervention