Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia

Conditions
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Haemophilia

Intervention / Treatment
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* Other: Patients with haemophilia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia<br>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 . | Other: Patients with haemophilia<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration of the uPatient platform | This register indicates the number of infusions | Screening visit | 
| Change from baseline the quality of life at 6 months and at the end of the study | Quality of life questionnaire (SF-36) | Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year | 
| Change from baseline the perception of disease at 6 months and at the end of the study | Questionnaire to evaluate the perception of disease (Questionnaire IPQ-R) | Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year | 
| Change from baseline the compliance to the prophylactic treatment at 6 months and at the end of the study | Spanish version of the questionnaire for compliance to prophylactic treatment in patients with haemophilia (Veritas-Pro). | Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year | 
| Change from baseline the joint status at the end of the study | Spanish version of the Haemophilia Joint Health Score (HJHS), to assess the joint status in patients with hemophilia | Screening visit and through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilia, Adherence, Prophylaxis treatment, Quality of Life, Illness Behavior, Veritas-Pro questionnaire, uPatient