Validation of VascuQol-6 Spanish Version

February 8, 2021 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Cross-cultural Adaptation and Validation of the VascuQol-6 Spanish Version

VascuQol (VQ) is a specific questionnaire to assess the quality of life of patients with critical limb ischemia which is also used as an index in vascular registries. The original version has 25 items (VQ-25), divided into 5 subscales or domains: pain, symptoms, activity, social and emotional. The shortened version, VascuQol-6 (VQ-6) is made up of 6 questions and 4 possible answers, which score from 1 (worst quality of life perceived by the patient) to 4 (best quality of life perceived by the patient). The total score is between 6 and 24, and a higher value is related to better health.

While the VQ-25 questionnaire has been translated and validated in 21 languages, the shortened version VQ-6 has been translated and validated in some languages, not including Spanish. As it is a fast and easy-to-use tool iwhich has demonstrated statistical validation to measure PAD in other versions of the same questionnaire (other languages), a cross-cultural adaptation and statistical validation of the questionnaire from English to Spanish will be carried out.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Jimenez Diaz Foundation University Hospital
        • Contact:
          • Barbara Soria-Juan, MD
      • Madrid, Spain
        • Recruiting
        • La Paz University Hospital
        • Contact:
          • Barbara Soria-Juan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited at the Angiology and Vascular Surgery consultation

Description

Inclusion Criteria:

  • Patients over 18 years of age
  • With a diagnosis of Peripheral Arterial Disease (intermittent claudication and critical lower limb ischemia)
  • Whose first language is Spanish
  • Who sign the informed consent.

Exclusion Criteria:

  • Patients with cognitive impairment that difficults understanding of the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-test group
After translation to Spanish, VQ-6 questionnaire is given to 20 patients to assess understanding by the patient.
Other: VascuQol-6 questionnaire Spanish version
VascuQol-6 questionnaire was translated by two professional translators into Spanish.
Test and re-test group
80 patients will be recruited to answer VQ-6 questionnaire and SF-12 questionnaire. After 3-4 weeks, these patients will be re-asked with the same questionnaires.
Other: VascuQol-6 questionnaire Spanish version
VascuQol-6 questionnaire was translated by two professional translators into Spanish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability
Time Frame: 3 -4 weeks from basal
Reliability refers to the degree to which an instrument is capable of measuring without errors. It measures the proportion or variation in the measurements that is due to the diversity of values adopted by the variable and not to the possible systematic or random error. Reliability will be assessed trough Cronbach's alpha coefficient measured for every item of the questionnaire.
3 -4 weeks from basal
Reproducibility
Time Frame: 3-4 weeks from basal
Reproducibility of intra-observer reliabilty refers to the repeatibility of the instrument, when it is administered with the same method to the same population at two times. Kappa Index will be measured
3-4 weeks from basal
Validity
Time Frame: 3-4 weeks from basal
Validity is the ability of the questionnaire to measure the construct for which it has been designed. Pearson correlation between the domains of the questionnaire and ABI from each patient will be measured
3-4 weeks from basal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2019

Primary Completion (Anticipated)

February 15, 2021

Study Completion (Anticipated)

February 15, 2021

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALVAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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