Peripheral Artery DiseaseNCT04741321
Validation of VascuQol-6 Spanish Version
An observational study of Peripheral Artery Disease, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- VascuQol-6 questionnaire Spanish version
- How many people
- 104 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Sep 2019to 15 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at the Angiology and Vascular Surgery consultation
Who may be able to join
- 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.
Who cannot join
- Patients with cognitive impairment that difficults understanding of the questionnaire
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Jimenez Diaz Foundation University Hospital
Madrid
Barbara Soria-Juan, MD
- Recruiting
La Paz University Hospital
Madrid
Barbara Soria-Juan, MD
About this study
Official title: 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- VascuQol-6 questionnaire Spanish version
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VascuQol-6 questionnaire Spanish versionOther
VascuQol-6 questionnaire was translated by two professional translators into Spanish.
| Study group | Role | What they receive |
|---|---|---|
| Pre-test group | After translation to Spanish, VQ-6 questionnaire is given to 20 patients to assess understanding by the patient. Receives: Other: VascuQol-6 questionnaire Spanish version | |
| 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. Receives: Other: VascuQol-6 questionnaire Spanish version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
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.
Measured: 3 -4 weeks from basal
Reproducibility
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
Measured: 3-4 weeks from basal
Validity
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
Measured: 3-4 weeks from basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 Sep 2019
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741321
- Sponsor's protocol ID
- VALVAS
- Status last verified
- Jan 2021
- First submitted
- 2 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Olmedo JMD, Mendoza JAP, Reina-Bueno M. Revisión sistemática sobre el impacto de las complicaciones podológicas de la diabetes mellitus sobre la calidad de vida. Rev Esp Podol. 2017;28(1):30-6.
Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622-9. doi: 10.7326/0003-4819-118-8-199304150-00009.
PubMed 8452328Schwartzmann L. CALIDAD DE VIDA RELACIONADA CON LA SALUD: ASPECTOS CONCEPTUALES. Cienc Enferm. diciembre de 2003;9(2):09- 21.
Guía de Consenso Multidisciplinar en Enfermedad Arterial Periférica de extremidades inferiores - Acta Sanitaria.
Serrano Hernando FJ, Martin Conejero A. [Peripheral artery disease: pathophysiology, diagnosis and treatment]. Rev Esp Cardiol. 2007 Sep;60(9):969-82. doi: 10.1157/13109651. Spanish.
PubMed 17915154Soria-Juan B, Escacena N, Capilla-Gonzalez V, Aguilera Y, Llanos L, Tejedo JR, Bedoya FJ, Juan V, De la Cuesta A, Ruiz-Salmeron R, Andreu E, Grochowicz L, Prosper F, Sanchez-Guijo F, Lozano FS, Miralles M, Del Rio-Sola L, Castellanos G, Moraleda JM, Sackstein R, Garcia-Arranz M, Garcia-Olmo D, Martin F, Hmadcha A, Soria B; Collaborative Working Group "Noma Project Team". Cost-Effective, Safe, and Personalized Cell Therapy for Critical Limb Ischemia in Type 2 Diabetes Mellitus. Front Immunol. 2019 Jun 4;10:1151. doi: 10.3389/fimmu.2019.01151. eCollection 2019.
PubMed 31231366Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
PubMed 28938901Morgan MB, Crayford T, Murrin B, Fraser SC. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg. 2001 Apr;33(4):679-87. doi: 10.1067/mva.2001.112326.
PubMed 11296317Poku E, Duncan R, Keetharuth A, Essat M, Phillips P, Woods HB, Palfreyman S, Jones G, Kaltenthaler E, Michaels J. Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties. Health Qual Life Outcomes. 2016 Nov 24;14(1):161. doi: 10.1186/s12955-016-0563-y.
PubMed 27881127Nordanstig J, Wann-Hansson C, Karlsson J, Lundstrom M, Pettersson M, Morgan MB. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014 Mar;59(3):700-7. doi: 10.1016/j.jvs.2013.08.099. Epub 2013 Dec 15.
PubMed 24342060de Almeida Correia M, Andrade-Lima A, Mesquita de Oliveira PL, Domiciano RM, Ribeiro Domingues WJ, Wolosker N, Puench-Leao P, Ritti-Dias RM, Cucato GG. Translation and Validation of the Brazilian-Portuguese Short Version of Vascular Quality of Life Questionnaire in Peripheral Artery Disease Patients with Intermittent Claudication Symptoms. Ann Vasc Surg. 2018 Aug;51:48-54.e1. doi: 10.1016/j.avsg.2018.02.026. Epub 2018 May 15.
PubMed 29772330Frans FA, van Wijngaarden SE, Met R, Koelemay MJ. Validation of the Dutch version of the VascuQol questionnaire and the Amsterdam Linear Disability Score in patients with intermittent claudication. Qual Life Res. 2012 Oct;21(8):1487-93. doi: 10.1007/s11136-011-0060-z. Epub 2011 Nov 15.
PubMed 22083223Ramada-Rodilla JM, Serra-Pujadas C, Delclos-Clanchet GL. [Cross-cultural adaptation and health questionnaires validation: revision and methodological recommendations]. Salud Publica Mex. 2013 Jan-Feb;55(1):57-66. doi: 10.1590/s0036-36342013000100009. Spanish.
PubMed 23370259Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010 Jul;63(7):737-45. doi: 10.1016/j.jclinepi.2010.02.006.
PubMed 20494804Aday LA, Cornelius LJ, Steven F, Cohen B, Aday LA, Cornelius LJ, et al. Published by Jossey-Bass.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of the VascuQol-6 Spanish Version
- ClinicalTrials.gov ID
- NCT04741321
- Acronym / sponsor ID
- VALVAS
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 5 Feb 2021 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-test group | – | Other: VascuQol-6 questionnaire Spanish versionAfter translation to Spanish, VQ-6 questionnaire is given to 20 patients to assess understanding by the patient. |
| Test and re-test group | – | Other: VascuQol-6 questionnaire Spanish version80 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the Angiology and Vascular Surgery consultation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with cognitive impairment that difficults understanding of the questionnaire
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 |
|---|---|---|
| VascuQol-6 questionnaire Spanish versionVascuQol-6 questionnaire was translated by two professional translators into Spanish. | Other | Pre-test group, Test and re-test group |
Primary outcome
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- BackgroundOlmedo JMD, Mendoza JAP, Reina-Bueno M. Revisión sistemática sobre el impacto de las complicaciones podológicas de la diabetes mellitus sobre la calidad de vida. Rev Esp Podol. 2017;28(1):30-6.
- Background: PubMed 8452328Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622-9. doi: 10.7326/0003-4819-118-8-199304150-00009.
- BackgroundSchwartzmann L. CALIDAD DE VIDA RELACIONADA CON LA SALUD: ASPECTOS CONCEPTUALES. Cienc Enferm. diciembre de 2003;9(2):09- 21.
- BackgroundGuía de Consenso Multidisciplinar en Enfermedad Arterial Periférica de extremidades inferiores - Acta Sanitaria.
- Background: PubMed 17915154Serrano Hernando FJ, Martin Conejero A. [Peripheral artery disease: pathophysiology, diagnosis and treatment]. Rev Esp Cardiol. 2007 Sep;60(9):969-82. doi: 10.1157/13109651. Spanish.
- Background: PubMed 31231366Soria-Juan B, Escacena N, Capilla-Gonzalez V, Aguilera Y, Llanos L, Tejedo JR, Bedoya FJ, Juan V, De la Cuesta A, Ruiz-Salmeron R, Andreu E, Grochowicz L, Prosper F, Sanchez-Guijo F, Lozano FS, Miralles M, Del Rio-Sola L, Castellanos G, Moraleda JM, Sackstein R, Garcia-Arranz M, Garcia-Olmo D, Martin F, Hmadcha A, Soria B; Collaborative Working Group "Noma Project Team". Cost-Effective, Safe, and Personalized Cell Therapy for Critical Limb Ischemia in Type 2 Diabetes Mellitus. Front Immunol. 2019 Jun 4;10:1151. doi: 10.3389/fimmu.2019.01151. eCollection 2019.
- Background: PubMed 28938901Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
- Background: PubMed 11296317Morgan MB, Crayford T, Murrin B, Fraser SC. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg. 2001 Apr;33(4):679-87. doi: 10.1067/mva.2001.112326.
- Background: PubMed 27881127Poku E, Duncan R, Keetharuth A, Essat M, Phillips P, Woods HB, Palfreyman S, Jones G, Kaltenthaler E, Michaels J. Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties. Health Qual Life Outcomes. 2016 Nov 24;14(1):161. doi: 10.1186/s12955-016-0563-y.
- Background: PubMed 24342060Nordanstig J, Wann-Hansson C, Karlsson J, Lundstrom M, Pettersson M, Morgan MB. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014 Mar;59(3):700-7. doi: 10.1016/j.jvs.2013.08.099. Epub 2013 Dec 15.
- Background: PubMed 29772330de Almeida Correia M, Andrade-Lima A, Mesquita de Oliveira PL, Domiciano RM, Ribeiro Domingues WJ, Wolosker N, Puench-Leao P, Ritti-Dias RM, Cucato GG. Translation and Validation of the Brazilian-Portuguese Short Version of Vascular Quality of Life Questionnaire in Peripheral Artery Disease Patients with Intermittent Claudication Symptoms. Ann Vasc Surg. 2018 Aug;51:48-54.e1. doi: 10.1016/j.avsg.2018.02.026. Epub 2018 May 15.
- Background: PubMed 22083223Frans FA, van Wijngaarden SE, Met R, Koelemay MJ. Validation of the Dutch version of the VascuQol questionnaire and the Amsterdam Linear Disability Score in patients with intermittent claudication. Qual Life Res. 2012 Oct;21(8):1487-93. doi: 10.1007/s11136-011-0060-z. Epub 2011 Nov 15.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
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 Peripheral Artery Disease, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz 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 4 inclusion and 1 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 11 Feb 2021. 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?
Contact Barbara Soria-Juan, MD (+34 661295031, barbara.soria@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: 3 -4 weeks from basal). 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?
On the ClinicalTrials.gov record for NCT04741321, which also lists 20 linked publications.
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 11 Feb 2021.