Compares treatment burden and daily life in people with hemophilia on two treatment types
Studies how clotting factor treatment types affect burden and well-being in people with hemophilia.
Plain-language title generated from the registry record
Registry title: Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia
Key facts
- Where
- Oviedo, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with hemophilia A or B who take preventive clotting factor treatment. It studies how heavy the treatment feels and how it relates to sleep, adherence and self-efficacy.
- Age
- Over 18 years
- Sex
- Men only
- Disease stage
- Hemophilia A or B, mild, moderate or severe
- Earlier treatment
- Preventive (prophylactic) clotting factor treatment, short half-life or extended half-life, with the same regimen for at least six months
Main reasons for not taking part
- Has developed inhibitors or antibodies to FVIII or FIX concentrates
- Has another serious or disabling long-term illness (nerve, cancer, severe mental health or rheumatic)
- Has cognitive, language or sensory problems that prevent completing the questionnaires
- Takes part in another clinical trial or intensive monitoring program that could change how they see the treatment
Read by machine on 9 November 2026.
Where in Spain
- Universidad de OviedoOviedo, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Investigación en Hemofilia y Fisioterapia
- Trial code
- NCT07099313
- Record updated
- 5 August 2025
- Original description
Introduction: Hemophilia is a congenital coagulopathy characterised by recurrent haemarthrosis, leading to chronic arthropathy and functional impairment. Prophylactic treatment with extended half-life (EHL) or short half-life (SHL) clotting factor concentrates is the most effective strategy for preventing these episodes. EHL products have demonstrated haemostatic efficacy, with a lower frequency of infusions, potentially reducing the treatment burden, although their psychosocial impact has not yet been sufficiently explored.Read full original descriptionShow less
Association of Prophylactic Treatment With Treatment Burden, Self-efficacy, Adherence, Sleep Quality, and Locus of Control in Patients With Hemophilia; an Ambispective Cohort Study
Introduction: Hemophilia is a congenital coagulopathy characterised by recurrent haemarthrosis, leading to chronic arthropathy and functional impairment. Prophylactic treatment with extended half-life (EHL) or short half-life (SHL) clotting factor concentrates is the most effective strategy for preventing these episodes. EHL products have demonstrated haemostatic efficacy, with a lower frequency of infusions, potentially reducing the treatment burden, although their psychosocial impact has not yet been sufficiently explored.
Objectives: To evaluate the association between perceived treatment burden and psychosocial variables such as self-efficacy, adherence, sleep quality and health locus of control, depending on the type of treatment received (EHL or SHL).
Methods. Multicentre, ambispective cohort study. A total of 114 patients with haemophilia A or B undergoing EHL or SHL prophylactic treatment will be included. The primary variable will be treatment burden (Treatment Burden Questionnaire). Secondary variables will be perceived self-efficacy (General Self-Efficacy Scale), adherence (Torres scale), sleep quality (Pittsburgh Sleep Quality Index), treatment adherence (Torres Questionnaire) and health locus of control (Multidimensional Health Locus of Control). Potential confounding variables will include sociodemographic data (age, educational level, living arrangements) and clinical data (number of weekly infusions, type of hospital).
Expected results: Patients treated with extended-half-life products are expected to report lower treatment burden, higher self-efficacy and better sleep quality, regardless of sociodemographic or clinical factors.
Inclusion: Patients over 18 years of age; Patients with a medical diagnosis of hemophilia A or B; Patients who, regardless of disease phenotype (mild, moderate or severe), are receiving prophylactic treatment with recombinant or plasma clotting factor concentrates, either short half-life or extended half-life; Patients must have maintained the same treatment regimen (SHL or EHL) continuously for at least six months prior to participation.
Exclusion: Patients who have developed inhibitors or antibodies to FVIII or FIX concentrates; People with a concomitant diagnosis of other serious or disabling chronic diseases (neurological, oncological, severe psychiatric or rheumatological) that may interfere with the perceived burden of treatment, sleep quality, functionality or perception of self-efficacy; Patients with cognitive, linguistic or sensory impairments that prevent them from correctly understanding and completing the questionnaires; Patients who are participating in clinical trials or intensive monitoring programmes that may alter their perception of the treatment and generate biases in the evaluation.