HaemophiliaNCT02582450
Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia
An observational study of Haemophilia, run by Real Fundación Victoria Eugenia at 1 site in Spain.
Trial summary
Research project for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and… Read more about this study
- Who is it for?
- Ages 13 to 65 years, men only
- Conditions the study is for
- Haemophilia
- What is being tested?
- Patients with haemophilia
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Dec 2015
- 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 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with haemophilia around the country that will participate in study.
Who may be able to join
- Patients with hemophilia A and B
- Patients who have previously signed the informed consent document
Who cannot join
- Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
- Patients with cognitive impairment, or oral or written understanding
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Real Fundación Victoria Eugenia
Madrid, Madrid, 28029
Rubén Cuesta-Barriuso, PhD, +34 913146508, ruben.cuestab@gmail.com
About this study
Official title: Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project
Research project for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and reliability analysis with large sample of patients.
Read the detailed description
The validated questionnaire obtained in this project will identify the actual degree of patient compliance to drug therapy, using as gold standard the difference between the treatment prescribed and administered.
- Conditions
- Haemophilia
- Being tested
- Patients with haemophilia
- Keywords
- Haemophilia, Adherence of Treatment, Knowledge of Illness, Medical-patient Relationship, Illness Behavior, Treatment Difficulties, Veritas
- 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
Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Patients with haemophilia | Sample of patients with haemophilia over 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire. Receives: Other: Patients with haemophilia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation of the original questionnaire (English) to Spanish
Three health experienced in the treatment of hemophilia and knowledge of English, translated into Spanish the HAL and HEP questionnaire. Two native speakers (English and Spanish), reverse-translate the original text of the HAL and HEP questionnaires and the text translated by the Spanish health.
Measured: 1 day (Screening visit)
The translated version of the questionnaire
10 patients with hemophilia adults enrolled randomly will participate in the pilotage.
The clarity of the questions in Spanish translated version and the relevance of each of the items of the questionnaires will be evaluated.
Measured: 1 day (Screening visit)
Sending the questionnaire to a large sample of patients for final validation
70 patients with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.
Measured: 1 day (Screening visit)
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 startSep 2015
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Collaborators
- Medtep Inc.
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Real Fundación Victoria Eugenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582450
- Sponsor's protocol ID
- Veritas-Validation
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project
- ClinicalTrials.gov ID
- NCT02582450
- Acronym / sponsor ID
- Veritas-Validation
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Adherence of Treatment, Knowledge of Illness, Medical-patient Relationship, Illness Behavior, Treatment Difficulties, Veritas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Collaborators
- Medtep Inc.
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (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 for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and reliability analysis with large sample of patients.
Detailed description
The validated questionnaire obtained in this project will identify the actual degree of patient compliance to drug therapy, using as gold standard the difference between the treatment prescribed and administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with haemophilia | – | Other: Patients with haemophiliaSample of patients with haemophilia over 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia around the country that will participate in study.
Key inclusion criteria (2 listed)
- Patients with hemophilia A and B
- Patients who have previously signed the informed consent document
Key exclusion criteria (2 listed)
- Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
- Patients with cognitive impairment, or oral or written understanding
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 haemophiliaPiloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire. | Other | Patients with haemophilia |
Primary outcome
Translation of the original questionnaire (English) to Spanish
Time frame: 1 day (Screening visit)
Three health experienced in the treatment of hemophilia and knowledge of English, translated into Spanish the HAL and HEP questionnaire. Two native speakers (English and Spanish), reverse-translate the original text of the HAL and HEP questionnaires and the text translated by the Spanish health.
The translated version of the questionnaire
Time frame: 1 day (Screening visit)
10 patients with hemophilia adults enrolled randomly will participate in the pilotage. The clarity of the questions in Spanish translated version and the relevance of each of the items of the questionnaires will be evaluated.
Sending the questionnaire to a large sample of patients for final validation
Time frame: 1 day (Screening visit)
70 patients with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by Real Fundación Victoria Eugenia at 1 site in Spain.
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 2 inclusion and 2 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Rubén Cuesta-Barriuso, PhD (+34 913146508, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation of the original questionnaire (English) to Spanish (time frame: 1 day (Screening visit)). The study lists 3 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 21 Oct 2015.