Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia

Haemophilia Clinical Trial

— uPatient  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02581735
• Other study ID #: uPatient
• Status: Active, not recruiting
• Phase: N/A
• First received: October 13, 2015
• Last updated: June 29, 2016
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: June 2016
• Source: Real Fundación Victoria Eugenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Intervention

Other:
• 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 .

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Real Fundación Victoria Eugenia	Medtep Inc., Universidad de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registration of the uPatient platform	This register indicates the number of infusions	Screening visit
Primary	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
Primary	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
Primary	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
Primary	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