Accessibility of Prophylaxis and On-demand Treatment for Persons With Haemophilia and Other Coagulation Deficiencies
PHAREO
Prophylaxis and On-demand Treatment for Persons With Haemophilia and Other Coagulation Deficiencies: a Comparison of Perceived and Observed Accessibility in the Auvergne-Rhône-Alpes Region (France)
1 other identifier
observational
500
1 country
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Shorter than P25 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2020
CompletedFirst Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2021
CompletedMay 14, 2021
February 1, 2021
7 months
February 11, 2021
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To assess the perception of persons with haemophilia and other coagulation deficiencies regarding the accessibility to prophylactic and on-demand antihemorrhagic treatment
The perception is defined by the satisfaction level of the survey participants, measured with on item in the questionnaire (Very satisfied / Rather satisfied / Rather not satisfied / Not satisfied).
Through study completion, on average 6 months.
To measure the accessibility of persons with haemophilia and other coagulation deficiencies regarding the accessibility to prophylactic and on-demand antihemorrhagic treatment
The accessibility is measured by spatial analysis, representing the distance between the home and/or work zip codes and the hospital pharmacy zip code.
Through study completion, on average 6 months.
To compare the perception and the spatial accessibility of persons with haemophilia and other coagulation deficiencies regarding prophylactic and on-demand antihemorrhagic treatment
The mean distances between the 4-groups of satisfaction level are compared using an analysis of variance (ANOVA).
Through study completion, on average 6 months.
Secondary Outcomes (5)
To determine if the severity of the disease would be a factor for encouraging or limiting the perception of accessibility to prophylactic or on-demand anti-haemorrhagic treatments
Through study completion, on average 6 months.
To determine if the age of the patient would be a factor for encouraging or limiting the perception of accessibility to prophylactic or on-demand anti-haemorrhagic treatments
Through study completion, on average 6 months.
To determine if the condition of access to hospital would be a factor for encouraging or limiting the perception of accessibility to prophylactic or on-demand anti-haemorrhagic treatments
Through study completion, on average 6 months.
To determine if the level of autonomy of the participant would be a factor for encouraging or limiting the perception of accessibility to prophylactic or on-demand anti-haemorrhagic treatments
Through study completion, on average 6 months.
To determine if the availability of the hospital pharmacy would be a factor for encouraging or limiting the perception of accessibility to prophylactic or on-demand anti-haemorrhagic treatments
Through study completion, on average 6 months.
Eligibility Criteria
The included subjects comprise people with haemophilia or other coagulation deficiencies, with no limitation of age, treated by prophylaxis or on-demand treatment, in one of the authorized hospital pharmacies in the Auvergne-Rhone-Alpes region (France).
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (34)
Centre Hospitalier Albertville-Moûtiers
Albertville, 73200, France
Centre Hospitalier Annecy Genevois
Annecy, 74370, France
Centre Hospitalier d'Ardèche Nord
Annonay, 07103, France
Centre Hospitalier d'Ardèche Méridionale
Aubenas, 07200, France
Centre Hospitalier Henri Mondor d'Aurillac
Aurillac, 15000, France
Centre Hospitalier de Belley
Belley, 01300, France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, 01012, France
Centre hospitalier de Bourg St Maurice
Bourg-Saint-Maurice, 73700, France
Centre Hospitalier Pierre Oudot
Bourgoin, 38300, France
Groupement Hospitalier Est, Hospices Civils de Lyon
Bron, 69500, France
Centre Hospitalier de Chambéry - Hôpital Savoie
Chambéry, 73000, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63100, France
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130, France
Hôpital Nord Ouest de Villefranche-sur-Saône
Gleizé, 69400, France
Centre Hospitalier Universitaire Grenoble - Alpes
La Tronche, 38700, France
Hôpital Edouard herriot, Hospices Civils de Lyon
Lyon, 69003, France
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004, France
Centre Hospitalier du Forez
Montbrison, 42600, France
Centre Hospitalier de Montélimar
Montélimar, 26200, France
Hôpital de Montluçon
Montluçon, 03100, France
Centre Hospitalier de Moulins-Yzeure
Moulins, 03006, France
Centre Hospitalier Du Haut Bugey
Oyonnax, 01100, France
Centre Hospitalier des Vals d'Ardeche
Privas, 07007, France
Centre Hospitalier de Roanne
Roanne, 42300, France
Hôpitaux Drôme Nord
Romans-sur-Isère, 26100, France
Pharmacie Centrale, Hospices Civils de Lyon
Saint-Genis-Laval, 69230, France
Centre Hospitalier Intercommunal Sud-Léman Valserine
Saint-Julien-en-Genevois, 74164, France
Centre Hospitalier Uuniversitaire Nord, Saint-Étienne
Saint-Priest-en-Jarez, 42270, France
Hôpitaux du Pays du Mont-Blanc
Sallanches, 74700, France
Hôpital Nord-Ouest Tarare-Grandris
Tarare, 69170, France
Hopitaux du Léman
Thonon-les-Bains, 74203, France
Centre Hospitalier de Valence
Valence, 26000, France
Centre Hospitalier de Vichy
Vichy, 03200, France
Centre Hospitalier Lucien Hussel
Vienne, 38200, France
Related Publications (2)
Leroy V, Freyssenge J, Renard F, Tazarourte K, Negrier C, Chamouard V. Access to treatment among persons with hemophilia: A spatial analysis assessment in the Rhone-Alpes region, France. J Am Pharm Assoc (2003). 2019 Nov-Dec;59(6):797-803. doi: 10.1016/j.japh.2019.07.006. Epub 2019 Aug 9.
PMID: 31405805BACKGROUNDSusen S, Gruel Y, Godier A, Harroche A, Chambost H, Lasne D, Rauch A, Roullet S, Fontana P, Goudemand J, de Maistre E, Chamouard V, Wibaut B, Albaladejo P, Negrier C. Management of bleeding and invasive procedures in haemophilia A patients with inhibitor treated with emicizumab (Hemlibra(R) ): Proposals from the French network on inherited bleeding disorders (MHEMO), the French Reference Centre on Haemophilia, in collaboration with the French Working Group on Perioperative Haemostasis (GIHP). Haemophilia. 2019 Sep;25(5):731-737. doi: 10.1111/hae.13817. Epub 2019 Jul 11.
PMID: 31294904BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laurie Fraticelli, PhD
RESCUe-RESUVal
- STUDY DIRECTOR
Julie Freyssenge, PhD
RESCUe-RESUVal
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
March 1, 2021
Study Start
September 21, 2020
Primary Completion
April 30, 2021
Study Completion
May 21, 2021
Last Updated
May 14, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
Patient information is held under legal and ethical obligations of confidentiality. As the disease is rare, information should not be used or disclosed in a form that might identify a patient without his or her consent.