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

NCT ID: NCT03054662

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-16

Study Completion Date

2019-09-17

Brief Summary

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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

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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

Conditions

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Haemophilia Developing Countries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

monocentric prospective study with longitudinal data collection of a single group
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with Haemophilia

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

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

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

Improve biological diagnosis and follow-up of haemophilia

Intervention Type DIAGNOSTIC_TEST

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

Implement haemostatic non substitutive care of haemophilia

Intervention Type DRUG

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

Implement non haemostatic care of haemophilia

Intervention Type OTHER

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

Carriers for Haemophilia

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

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

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

Improve biological diagnosis and follow-up of haemophilia

Intervention Type DIAGNOSTIC_TEST

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

Implement haemostatic non substitutive care of haemophilia

Intervention Type DRUG

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

Interventions

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Education

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

Intervention Type OTHER

Improve biological diagnosis and follow-up of haemophilia

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

Intervention Type DIAGNOSTIC_TEST

Implement haemostatic non substitutive care of haemophilia

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

Intervention Type DRUG

Implement non haemostatic care of haemophilia

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

Intervention Type OTHER

Other Intervention Names

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Physiotherapy, dental care, pain killers

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Federation of Hemophilia

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine M Lambert, MD

Role: STUDY_DIRECTOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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CHU de Yopougon

Abidjan, , Côte d’Ivoire

Site Status

Countries

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Côte d’Ivoire

Other Identifiers

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002/MSHP/CNER-kp

Identifier Type: -

Identifier Source: org_study_id

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