HaemophiliaVALIDATIONNCT02512211
Validation of Questionnaires HAL and HEP
An observational study of Haemophilia, run by Universidad Católica San Antonio de Murcia at 2 sites in Spain.
Trial summary
Spanish Validation of HAL and HEP questionnaire by double translation (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. The final validity will be obtained with a sample of 60-100 patients with hemophilia Read more about this study
- Who is it for?
- Ages 8 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemophilia
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2015to Oct 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 8 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with haemophilia and parents of children with hemophilia around the country that will participate in study.
Who may be able to join
- Patients with hemophilia A and B
- Parents of children with hemophilia A and B, under 18
- 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
2 sites in 1 country.
Spain2 sites
Universidad de Murcia
Murcia, Murcia, 30100
Universidad Católica San Antonio, Murcia
Murcia, Murcia, 30107
About this study
Official title: Spanish Validation of "Haemophilia Activities List" (HAL) and "Specific Sport Scale" (HEP-Test-Q) Questionnaires
Spanish Validation of HAL and HEP questionnaire by double translation (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. The final validity will be obtained with a sample of 60-100 patients with hemophilia
Read the detailed description
Validation of the Spanish hemophilia specific questionnaires: HAL and HEP (adult version version version children and parents). To do this, there will be a double inverse translation, a pilotage of validity and clarity with a small sample of subjects and analysis of reliability and validity with more than 100 patients and parents of children with hemophilia to complete the validation.
- Conditions
- Haemophilia
- Keywords
- Hemophilia, Validation, Questionnaires, Activities, Sport, Patients
- Medical subject headings
- Hemophilia A, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients adults | 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 HAL and HEP questionnaires | |
| Children with haemophilia | Sign hemophilia patients under 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the HAL and HEP questionnaires | |
| Parents of children with haemophilia | Sample of parents of children with hemophilia under 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the HAL and HEP questionnaires |
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
5 patients with hemophilia under 16, 5 patients with hemophilia adults , and 5 parents of children with hemophilia 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
40 hemophilia patients under 16 years old, 60 adult patients with hemophilia and 60 parents of children 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 posted30 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionOct 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
- Investigators
- RUBEN CUESTA-BARRIUSO, PhD, Principal investigator, Universidad Católica San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512211
- Sponsor's protocol ID
- VALIDATION
- Other IDs
- VALIDATION
- Acronym
- VALIDATION
- Status last verified
- Jun 2016
- First submitted
- 22 Jul 2014
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Validation of "Haemophilia Activities List" (HAL) and "Specific Sport Scale" (HEP-Test-Q) Questionnaires
- ClinicalTrials.gov ID
- NCT02512211
- Acronym / sponsor ID
- VALIDATION / VALIDATION
- Conditions
- Haemophilia
- Keywords
- Hemophilia, Validation, Questionnaires, Activities, Sport, Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 30 Jul 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.
Spanish Validation of HAL and HEP questionnaire by double translation (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. The final validity will be obtained with a sample of 60-100 patients with hemophilia
Detailed description
Validation of the Spanish hemophilia specific questionnaires: HAL and HEP (adult version version version children and parents). To do this, there will be a double inverse translation, a pilotage of validity and clarity with a small sample of subjects and analysis of reliability and validity with more than 100 patients and parents of children with hemophilia to complete the validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients adults | – | –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 HAL and HEP questionnaires |
| Children with haemophilia | – | –Sign hemophilia patients under 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the HAL and HEP questionnaires |
| Parents of children with haemophilia | – | –Sample of parents of children with hemophilia under 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the HAL and HEP questionnaires |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia and parents of children with hemophilia around the country that will participate in study.
Key inclusion criteria (3 listed)
- Patients with hemophilia A and B
- Parents of children with hemophilia A and B, under 18
- 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.
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)
5 patients with hemophilia under 16, 5 patients with hemophilia adults , and 5 parents of children with hemophilia 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)
40 hemophilia patients under 16 years old, 60 adult patients with hemophilia and 60 parents of children 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 1 Jul 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.
RUBEN CUESTA-BARRIUSO, PhD principal investigator
Universidad Católica San Antonio
2 sites 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 Universidad Católica San Antonio de Murcia at 2 sites 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 3 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 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
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 1 Jul 2016.