NCT02581735

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

October 13, 2015

Last Update Submit

June 29, 2016

Conditions

Haemophilia

Keywords

HaemophiliaAdherenceProphylaxis treatmentQuality of LifeIllness BehaviorVeritas-Pro questionnaireuPatient

Outcome Measures

Primary Outcomes (5)

  • Registration of the uPatient platform

    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

    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

    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

    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

    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

Study Arms (1)

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

Interventions

Patients with haemophiliaOTHER

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

Eligibility Criteria

Age13 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with haemophilia

You may qualify if:

  • Patients diagnosed with hemophilia A or B
  • Patients over 13 years old
  • Patients on prophylactic treatment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemophilia AIllness Behavior

Interventions

hydroxyethyl methacrylate

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Real Fundación Victoria Eugenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 21, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06