Haemophilia
Conditions
Keywords
Haemophilia, Adherence, Prophylaxis treatment, Quality of Life, Illness Behavior, Veritas-Pro questionnaire, uPatient
Brief summary
Research project whose main objective is to evaluate the use of a technology platform (uPatient) to register the prophylactic treatment of patients with hemophilia treated in different Hematology and Hemotherapy services of several hospitals in Spain.
Detailed description
The data obtained in this project will identify the level of compliance to the pharmacological treatment of patients with hemophilia prophylaxis. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for patients with hemophilia. Clinical data were also obtained regarding the joint of patients participating in the study state.
Interventions
Using the platform Upatient, patients with hemophilia will register for one year, the prophylactic treatment who receive at home. Likewise, they indicate a replacement therapy as a result of joint bleeds. At baseline, a month, 6 months and at the end of the study, patients shall complete two questionnaires. The same way in the initial evaluation and end of the study, the clinical joint status will be evaluated with HJHS scale .
Sponsors
Universidad de Murcia
Medtep Inc.
Real Fundación Victoria Eugenia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
13 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with hemophilia A or B * Patients over 13 years old * Patients on prophylactic treatment.
Exclusion criteria
* Patients who do not sign the informed consent document * Patients who do not make domiciliary self-treatment * Patients who do not have good adhesion to prophylactic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Registration of the uPatient platform | Screening visit | This register indicates the number of infusions |
| Change from baseline the quality of life at 6 months and at the end of the study | Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year | Quality of life questionnaire (SF-36) |
| Change from baseline the perception of disease at 6 months and at the end of the study | Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year | Questionnaire to evaluate the perception of disease (Questionnaire IPQ-R) |
| Change from baseline the compliance to the prophylactic treatment at 6 months and at the end of the study | Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year | Spanish version of the questionnaire for compliance to prophylactic treatment in patients with haemophilia (Veritas-Pro). |
| Change from baseline the joint status at the end of the study | Screening visit and through study completion, an average of 1 year | Spanish version of the Haemophilia Joint Health Score (HJHS), to assess the joint status in patients with hemophilia |
Outcome results
None listed