---
title: Validation of Questionnaires HAL and HEP
nct_id: NCT02512211
overall_status: UNKNOWN
sponsor: Universidad Católica San Antonio de Murcia
study_type: OBSERVATIONAL
primary_condition: Haemophilia
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02512211.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02512211"
ct_last_update_post_date: 2016-07-01
last_seen_at: "2026-05-12T07:21:17.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Validation of Questionnaires HAL and HEP

**Official Title:** Spanish Validation of "Haemophilia Activities List" (HAL) and "Specific Sport Scale" (HEP-Test-Q) Questionnaires

**NCT ID:** [NCT02512211](https://clinicaltrials.gov/study/NCT02512211)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Universidad Católica San Antonio de Murcia
- **Conditions:** Haemophilia
- **Start Date:** 2015-10
- **Completion Date:** 2016-10
- **CT.gov Last Update:** 2016-07-01

## Brief 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

## 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.

## Eligibility

- **Minimum age:** 8 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
* Patients with cognitive impairment, or oral or written understanding
```

## Arms

- **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

## Primary Outcomes

- **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.

## Locations (2)

- Universidad de Murcia, Murcia, Murcia, Spain
- Universidad Católica San Antonio, Murcia, Murcia, Murcia, Spain

## Recent Field Changes (last 30 days)

- `locations.universidad de murcia|murcia|murcia|spain` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universidad católica san antonio, murcia|murcia|murcia|spain` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02512211*  
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