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

Primary Purpose

Haemophilia, Developing Countries

Status

Completed

Phase

Not Applicable

Locations

Côte D'Ivoire

Study Type

Interventional

Intervention

Education

Improve biological diagnosis and follow-up of haemophilia

Implement haemostatic non substitutive care of haemophilia

Implement non haemostatic care of haemophilia

About this trial

This is an interventional other trial for Haemophilia focused on measuring Haemophilia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU de Yopougon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with Haemophilia

Carriers for Haemophilia

Arm Description

Male patients with severe and moderate haemophilia A and B in Ivory Coast

Carriers for severe and moderate haemophilia A and B in Ivory Coast

Outcomes

Primary Outcome Measures

Improve haemophilia care in Ivory Coast

Compare QoL questionnaires before and after the intervention phase

Improve haemophilia diagnosis of haemophilia in Ivory Coast

Compare the number of patients with haemophilia between the beginning and the end of the study

Improve haemophilia care in Ivory Coast

Compare the pain assessment before and after the intervention phase

Improve knowledge about haemophilia in Ivory Coast

Compare the knowledge queestionnaires about haemophilia before and after the intervention phase

Secondary Outcome Measures

Full Information

NCT ID

NCT03054662

First Posted

February 13, 2017

Last Updated

September 26, 2019

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

World Federation of Hemophilia

1. Study Identification

Unique Protocol Identification Number

NCT03054662

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 16, 2017 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

World Federation of Hemophilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haemophilia, Developing Countries

Keywords

Haemophilia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

monocentric prospective study with longitudinal data collection of a single group

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with Haemophilia

Arm Type

Experimental

Arm Description

Male patients with severe and moderate haemophilia A and B in Ivory Coast

Arm Title

Carriers for Haemophilia

Arm Type

Experimental

Arm Description

Carriers for severe and moderate haemophilia A and B in Ivory Coast

Intervention Type

Other

Intervention Name(s)

Education

Intervention Description

Education of patients and caregivers about haemophilia and carriers of haemophilia.

Intervention Type

Diagnostic Test

Intervention Name(s)

Improve biological diagnosis and follow-up of haemophilia

Intervention Description

train the laboratory to the diagnosis ans follow-up un haemophilia

Intervention Type

Drug

Intervention Name(s)

Implement haemostatic non substitutive care of haemophilia

Intervention Description

Implement the use of DDAVP and antifibrinolytics in patients with haemophilia and symptomatic carriers

Intervention Type

Other

Intervention Name(s)

Implement non haemostatic care of haemophilia

Other Intervention Name(s)

Physiotherapy, dental care, pain killers

Intervention Description

Implement regular physiotherapy, develop dental care, promote the regular use of pain killers

Primary Outcome Measure Information:

Title

Improve haemophilia care in Ivory Coast

Description

Compare QoL questionnaires before and after the intervention phase

Time Frame

2 years after intervention

Title

Improve haemophilia diagnosis of haemophilia in Ivory Coast

Description

Compare the number of patients with haemophilia between the beginning and the end of the study

Time Frame

3 years

Title

Improve haemophilia care in Ivory Coast

Description

Compare the pain assessment before and after the intervention phase

Time Frame

2 years after intervention

Title

Improve knowledge about haemophilia in Ivory Coast

Description

Compare the knowledge queestionnaires about haemophilia before and after the intervention phase

Time Frame

2 years after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine M Lambert, MD

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Study Director

Facility Information:

Facility Name

CHU de Yopougon

City

Abidjan

Country

Côte D'Ivoire

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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