Actively Recruiting
Association of Prophylactic Treatment With Treatment Burden, Self-efficacy, Adherence, Sleep Quality, and Locus of Control in Patients With Hemophilia; an Ambispective Cohort Study
Led by Investigación en Hemofilia y Fisioterapia · Updated on 2025-08-05
114
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hemophilia is a lifelong bleeding disorder marked by repeated joint bleeding that leads to chronic joint damage and difficulty in movement. This research aims to explore how different prophylactic clotting factor treatments, specifically those with extended half-life (EHL) and short half-life (SHL), affect patients' treatment burden and related psychosocial factors like self-efficacy, treatment adherence, sleep quality, and health control beliefs. The study involves patients with hemophilia A or B who are on either EHL or SHL clotting factor concentrates as preventive treatment. Participants must have been on the same treatment type for at least six months. The study collects data at a single screening visit, focusing on patient experiences and perceptions related to treatment burden and psychosocial well-being. During the screening visit, researchers will assess treatment burden using a questionnaire, along with measures of self-efficacy, adherence, sleep quality, and health locus of control. Sociodemographic and clinical information, such as age and frequency of infusions, will also be recorded. This observational study aims to understand how treatment type influences patients' daily life and well-being without altering their current care.
CONDITIONS
Brief Title
Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age.
- Male patients.
- Diagnosed with hemophilia A or B.
- Receiving prophylactic treatment with recombinant or plasma clotting factor concentrates, either short half-life or extended half-life.
- Have maintained the same treatment regimen (SHL or EHL) continuously for at least six months prior to participation.
You will not qualify if you...
- Developed inhibitors or antibodies to FVIII or FIX concentrates.
- Have a serious or disabling chronic disease such as neurological, oncological, severe psychiatric, or rheumatological conditions that could affect treatment burden or related perceptions.
- Have cognitive, linguistic, or sensory impairments preventing correct understanding and completion of questionnaires.
- Participating in other clinical trials or intensive monitoring programs that could bias evaluation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At the time of the study
Participants who are undergoing routine prophylactic treatment with clotting factor concentrates are observed to assess treatment burden and psychosocial variables.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Universidad de Oviedo
Oviedo, Principality of Asturias, Spain, 33006
Actively Recruiting
Research Team
R
Rubén Cuesta-Barriuso, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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