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Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia (uPatient)

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ClinicalTrials.gov Identifier: NCT02581735
Recruitment Status : Unknown
Verified June 2016 by Real Fundación Victoria Eugenia.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
Universidad de Murcia
Medtep Inc.
Information provided by (Responsible Party):
Real Fundación Victoria Eugenia

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.

Condition or disease Intervention/treatment
Haemophilia Other: Patients with haemophilia

Detailed 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.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia
Study Start Date : October 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 .

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 .





Primary Outcome Measures :
  1. Registration of the uPatient platform [ Time Frame: Screening visit ]
    This register indicates the number of infusions

  2. 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)

  3. 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)

  4. 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).

  5. 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



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Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with haemophilia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581735


Sponsors and Collaborators
Real Fundación Victoria Eugenia
Universidad de Murcia
Medtep Inc.
Investigators
Principal Investigator: Rubén Cuesta-Barriuso, PhD Real Fundación Victoria Eugenia

Responsible Party: Real Fundación Victoria Eugenia
ClinicalTrials.gov Identifier: NCT02581735     History of Changes
Other Study ID Numbers: uPatient
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016

Keywords provided by Real Fundación Victoria Eugenia:
Haemophilia
Adherence
Prophylaxis treatment
Quality of Life
Illness Behavior
Veritas-Pro questionnaire
uPatient

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn