Accessibility of Prophylaxis and On-demand Treatment for Persons With Haemophilia and Other Coagulation Deficiencies

Last updated: May 13, 2021
Sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemophilia

Treatment

N/A

Clinical Study ID

NCT04775888
2020PHAREO
  • All Genders

Study Summary

The current treatment of people with haemophilia and other bleeding deficiencies is largely based on clotting factor replacement therapy. The injections can be repeated several times a week according to a personalized schedule. To date, medications are exclusively dispensed in hospital pharmacies to ensure traceability and safety. This retrocession imposes accessibility constraints on patients and on their caregivers, increasing the burden of the disease, particularly in the organization of personal and professional daily life. The PHAREO study aims to investigate patients' perception of accessibility to anti-haemophilia drugs in relation to an evaluation of spatial accessibility in the Auvergne-Rhône-Alpes region (France) in order to consider, if necessary, ways of improving the pathway for patients and their caregivers.

Eligibility Criteria

Inclusion

Included:

  • Living person on the study start date and presenting with haemophilia or other coagulation deficiencies;

  • Treated with prophylaxis or on-demand anti-haemorrhagic treatments;

  • Location of medication dispensing within the hospital pharmacies of the HEsora network (Hémophilie Soins Rhône Alpes): 27 eligible hospital pharmacies in Rhône Alpes + <10 eligible hospital pharmacies in Auvergne

Excluded:

  • Home delivery (not included in the study via hospital pharmacy)

Study Design

Total Participants: 500
Study Start date:
September 21, 2020
Estimated Completion Date:
May 21, 2021

Study Description

Haemophilia is a rare constitutional hemorrhagic disease whose drug management is based on the use of chronic lifelong replacement therapy. For many years, the reference treatment, particularly in children, has been based on the use of anti-haemophilic drugs for prophylaxis requiring repeated injections several times a week according to a personalized schedule. In contrast, on-demand treatment is less and less used, particularly in patients with severe forms of haemophilia. Clinical and biological diagnosis, as well as the implementation and monitoring of treatments, are carried out within specialized hospital care structures affiliated with the French national reference center. Medications are dispensed as part of hospital retrocessions. This organization imposes constraints on patients and their caregivers due to their limited accessibility.

The burden related to this disease is probably due to the systematic use of specialized hospital teams such as doctors, nurses for self-injection training for example, and pharmacists. It now seems important to reflect on the evolution of patient pathways that were previously exclusively hospital-centred towards ambulatory care. To do this, various reflections need to be undertaken, including that relating to the accessibility of medication. Indeed, the monthly renewals of these chronic treatments force patients and their caregivers, as well as the parents of children, to go to the hospital, which frequently makes the organization of daily and professional life more cumbersome.

The PHAREO study aims to investigate patients' perception of accessibility to anti-haemophilia drugs in relation to an evaluation of spatial accessibility in order to consider, if necessary, ways of improving the pathway for patients and their caregivers.

The expected benefits of the study are to have: 1) an exhaustive description of the spatial accessibility of the cohort of people living with haemophilia to anti-haemophilia medication within the Auvergne Rhône Alpes region (France) and 2) a better understanding of their needs and their perceptions regarding access to on-demand and prophylactic treatments.

Connect with a study center

  • Centre Hospitalier Albertville-Moûtiers

    Albertville, 73200
    France

    Active - Recruiting

  • Centre Hospitalier Annecy Genevois

    Annecy, 74370
    France

    Active - Recruiting

  • Centre Hospitalier d'Ardèche Nord

    Annonay, 07103
    France

    Active - Recruiting

  • Centre Hospitalier d'Ardèche Méridionale

    Aubenas, 07200
    France

    Active - Recruiting

  • Centre Hospitalier Henri Mondor d'Aurillac

    Aurillac, 15000
    France

    Active - Recruiting

  • Centre Hospitalier de Belley

    Belley, 01300
    France

    Active - Recruiting

  • Centre hospitalier de Bourg St Maurice

    Bourg St Maurice, 73700
    France

    Active - Recruiting

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse, 01012
    France

    Active - Recruiting

  • Centre Hospitalier Pierre Oudot

    Bourgoin-Jallieu, 38300
    France

    Active - Recruiting

  • Groupement Hospitalier Est, Hospices Civils de Lyon

    Bron, 69500
    France

    Active - Recruiting

  • Centre Hospitalier de Chambéry - Hôpital Savoie

    Chambéry, 73000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63100
    France

    Active - Recruiting

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130
    France

    Active - Recruiting

  • Hôpital Nord Ouest de Villefranche-sur-Saône

    Gleizé, 69400
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Grenoble - Alpes

    La Tronche, 38700
    France

    Active - Recruiting

  • Hôpital Edouard herriot, Hospices Civils de Lyon

    Lyon, 69003
    France

    Active - Recruiting

  • Hôpital de la Croix-Rousse, Hospices Civils de Lyon

    Lyon, 69004
    France

    Active - Recruiting

  • Centre Hospitalier du Forez

    Montbrison, 42600
    France

    Active - Recruiting

  • Hôpital de Montluçon

    Montluçon, 03100
    France

    Active - Recruiting

  • Centre Hospitalier de Montélimar

    Montélimar, 26200
    France

    Active - Recruiting

  • Centre Hospitalier de Moulins-Yzeure

    Moulins, 03006
    France

    Active - Recruiting

  • Centre Hospitalier Du Haut Bugey

    Oyonnax, 01100
    France

    Active - Recruiting

  • Centre Hospitalier des Vals d'Ardeche

    Privas, 07007
    France

    Active - Recruiting

  • Centre Hospitalier de Roanne

    Roanne, 42300
    France

    Active - Recruiting

  • Hôpitaux Drôme Nord

    Romans-sur-Isère, 26100
    France

    Active - Recruiting

  • Pharmacie Centrale, Hospices Civils de Lyon

    Saint-Genis-Laval, 69230
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal Sud-Léman Valserine

    Saint-Julien-en-Genevois, 74164
    France

    Active - Recruiting

  • Centre Hospitalier Uuniversitaire Nord, Saint-Étienne

    Saint-Priest-en-Jarez, 42270
    France

    Active - Recruiting

  • Hôpitaux du Pays du Mont-Blanc

    Sallanches, 74700
    France

    Active - Recruiting

  • Hôpital Nord-Ouest Tarare-Grandris

    Tarare, 69170
    France

    Active - Recruiting

  • Hopitaux du Léman

    Thonon-les-Bains, 74203
    France

    Active - Recruiting

  • Centre Hospitalier de Valence

    Valence, 26000
    France

    Active - Recruiting

  • Centre Hospitalier de Vichy

    Vichy, 03200
    France

    Active - Recruiting

  • Centre Hospitalier Lucien Hussel

    Vienne, 38200
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.