HaemophiliauPatientNCT02581735
Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia
An observational study of Haemophilia, run by Real Fundación Victoria Eugenia.
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. Read more about this study
- Who is it for?
- Ages 13 to 50 years, men only
- Conditions the study is for
- Haemophilia
- What is being tested?
- Patients with haemophilia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Patients with haemophilia
Who may be able to join
- Patients diagnosed with hemophilia A or B
- Patients over 13 years old
- Patients on prophylactic treatment.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Haemophilia
- Being tested
- Patients with haemophilia
- Keywords
- Haemophilia, Adherence, Prophylaxis treatment, Quality of Life, Illness Behavior, Veritas-Pro questionnaire, uPatient
- Medical subject headings
- Hemophilia A, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Other: Patients with haemophilia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration of the uPatient platform
This register indicates the number of infusions
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: Screening visit and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Murcia, Medtep Inc.
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Real Fundación Victoria Eugenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581735
- Sponsor's protocol ID
- uPatient
- Acronym
- uPatient
- Status last verified
- Jun 2016
- First submitted
- 13 Oct 2015
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT02581735
- Acronym / sponsor ID
- uPatient / uPatient
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Adherence, Prophylaxis treatment, Quality of Life, Illness Behavior, Veritas-Pro questionnaire, uPatient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Collaborators
- Universidad de Murcia, Medtep Inc.
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haemophilia | – | Other: Patients with haemophiliaUsing 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 . |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with haemophilia
Key inclusion criteria (3 listed)
- Patients diagnosed with hemophilia A or B
- Patients over 13 years old
- Patients on prophylactic treatment.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with haemophiliaUsing 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 |
Primary outcome
Registration of the uPatient platform
Time frame: Screening visit
This register indicates the number of infusions
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)
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)
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).
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Real Fundación Victoria Eugenia
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by Real Fundación Victoria Eugenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration of the uPatient platform (time frame: Screening visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.