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Validation of VascuQol-6 Spanish Version

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04741321
Enrollment
104
Registered
2021-02-05
Start date
2019-09-15
Completion date
2021-02-15
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Brief summary

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.

Interventions

OTHERVascuQol-6 questionnaire Spanish version

VascuQol-6 questionnaire was translated by two professional translators into Spanish.

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reliability3 -4 weeks from basalReliability 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.
Reproducibility3-4 weeks from basalReproducibility 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
Validity3-4 weeks from basalValidity 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

Countries

Spain

Contacts

Primary ContactBarbara Soria-Juan, MD
barbara.soria@quironsalud.es+34 661295031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026