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

June 29, 2016 updated by: Real Fundación Victoria Eugenia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registration of the uPatient platform
Time Frame: Screening visit
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
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)
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
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
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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Real Fundación Victoria Eugenia

Collaborators

Universidad de Murcia
Medtep Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uPatient

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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