Overview

This trial is active, not recruiting.

Condition haemophilia
Treatment patients with haemophilia
Sponsor Real Fundación Victoria Eugenia
Collaborator Universidad de Murcia
Start date October 2015
End date November 2016
Trial size 40 participants
Trial identifier NCT02581735, uPatient

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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 .
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 .

Primary Outcomes

Measure
Registration of the uPatient platform
time frame: Screening visit
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
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
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
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

Eligibility Criteria

Male participants from 13 years up to 50 years old.

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

Additional Information

Official title Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia
Principal investigator Rubén Cuesta-Barriuso, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Real Fundación Victoria Eugenia.