NCT03054662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

February 13, 2017

Last Update Submit

September 26, 2019

Conditions

HaemophiliaDeveloping Countries

Keywords

Haemophilia

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Patients with Haemophilia

EXPERIMENTAL

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

Other: EducationDiagnostic Test: Improve biological diagnosis and follow-up of haemophiliaDrug: Implement haemostatic non substitutive care of haemophiliaOther: Implement non haemostatic care of haemophilia

Carriers for Haemophilia

EXPERIMENTAL

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

Other: EducationDiagnostic Test: Improve biological diagnosis and follow-up of haemophiliaDrug: Implement haemostatic non substitutive care of haemophilia

Interventions

EducationOTHER

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

Carriers for HaemophiliaPatients with Haemophilia
Improve biological diagnosis and follow-up of haemophiliaDIAGNOSTIC_TEST

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

Carriers for HaemophiliaPatients with Haemophilia
Implement haemostatic non substitutive care of haemophiliaDRUG

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

Carriers for HaemophiliaPatients with Haemophilia
Implement non haemostatic care of haemophiliaOTHER

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

Also known as: Physiotherapy, dental care, pain killers
Patients with Haemophilia

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Yopougon

Abidjan, Côte d’Ivoire

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Educational StatusPhysical Therapy ModalitiesDental CareAcetaminophen

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsTherapeuticsRehabilitationDentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Catherine M Lambert, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: monocentric prospective study with longitudinal data collection of a single group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

January 16, 2017

Primary Completion

December 31, 2018

Study Completion

September 17, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CÔ(1)