NCT07099313 Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia
| NCT ID | NCT07099313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Investigación en Hemofilia y Fisioterapia |
| Condition | Hemophilia |
| Study Type | OBSERVATIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2025-09-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 114 participants in total. It began in 2025-07-31 with a primary completion date of 2025-09-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Rubén Cuesta-Barriuso, PhD
PRINCIPAL INVESTIGATOR
Universidad de Oviedo
Frequently Asked Questions
Who can join the NCT07099313 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Hemophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07099313 currently recruiting?
Yes, NCT07099313 is actively recruiting participants. Contact the research team at cuestaruben@uniovi.es for enrollment information.
Where is the NCT07099313 trial being conducted?
This trial is being conducted at Oviedo, Spain.
Who is sponsoring the NCT07099313 clinical trial?
NCT07099313 is sponsored by Investigación en Hemofilia y Fisioterapia. The principal investigator is Rubén Cuesta-Barriuso, PhD at Universidad de Oviedo. The trial plans to enroll 114 participants.