Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia

Launched by INVESTIGACIÓN EN HEMOFILIA Y FISIOTERAPIA · Jul 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different types of preventive treatments for hemophilia affect patients’ daily lives and feelings about their care. Hemophilia is a condition where blood doesn’t clot properly, causing repeated joint bleeds that can lead to long-term joint problems. The study compares two types of clotting factor treatments: one that lasts longer in the body (extended half-life, or EHL) and one that doesn’t last as long and requires more frequent doses (short half-life, or SHL). Researchers want to understand how these treatments affect things like how hard patients feel their treatment is, how confident they feel managing their health, how well they sleep, and how closely they follow their treatment plan.

Men over 18 with hemophilia A or B who have been on the same preventive treatment (either EHL or SHL) for at least six months may be eligible to join. People with other serious health issues or who have developed resistance to treatment will not qualify. Participants will be asked to complete questionnaires about their treatment experience, confidence, sleep, and daily routines. The study aims to find out if the longer-lasting EHL treatment might make managing hemophilia easier and improve overall well-being. This information could help doctors and patients choose the best treatment approach to reduce the burden of care and improve quality of life.

Gender

MALE

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.