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| Name | Class |
|---|---|
| Universidad de Murcia | OTHER |
| Medtep Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemophilia | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with haemophilia | Other | 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 . |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia
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| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Real Fundación Victoria Eugenia | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2017 | |
| Reset | Jul 12, 2018 | |
| Release | Feb 19, 2019 | |
| Reset | May 31, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2017 | Jul 12, 2018 | |||
| Feb 19, 2019 |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D055809 | Illness Behavior |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C005044 | hydroxyethyl methacrylate |
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|
| May 31, 2019 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |