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

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.

Study Overview

• Status: Completed
• Conditions: Haemophilia; Developing Countries
• Intervention / Treatment: 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

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

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Côte D'Ivoire
  • Abidjan, Côte D'Ivoire
    • CHU de Yopougon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve haemophilia care in Ivory Coast	Compare QoL questionnaires before and after the intervention phase	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	3 years
Improve haemophilia care in Ivory Coast	Compare the pain assessment before and after the intervention phase	2 years after intervention
Improve knowledge about haemophilia in Ivory Coast	Compare the knowledge queestionnaires about haemophilia before and after the intervention phase	2 years after intervention

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: World Federation of Hemophilia
• Investigators: Study Director: Catherine M Lambert, MD, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Haemophilia
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A; Coagulants; Hemostatics
• Other Study ID Numbers: 002/MSHP/CNER-kp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No