Clinical Trial: Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Real Fundación Victoria Eugenia

Current Primary Outcome:

• Registration of the uPatient platform [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Original Primary Outcome:

• Registration of the uPatient platform [ Time Frame: Screening visit ]
  This register indicates the number of infusions, the cause of treatment (prophylaxis or on demand), the dose and the degree of patient activity.
• Change from baseline the quality of life at 6 months and at the end of the study [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Real Fundación Victoria Eugenia

Dates:
Date Received: October 13, 2015
Date Started: October 2015
Date Completion: November 2016
Last Updated: June 29, 2016
Last Verified: June 2016