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Validation of the VascuQoL-6 Questionnaire to Assess ePROM After Revascularization for Lower Limb Peripheral Arterial Disease in German-speaking Part of Switzerland (VascuQol6ValCH)

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ClinicalTrials.gov Identifier: NCT04709107
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Andrej Isaak, Kantonsspital Aarau

Study Description
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Brief Summary:
Two hundred patients evaluated to undergo revascularization (elective/emergent, surgical/interventional) for lower limb PAD at the cantonal hospital of Aarau, Switzerland, will, after consenting to participate in the study, be asked to fill up both SF-36 and VascuQol-6 questionnaires while sitting in a waiting room before the procedure and during the 30 days and 1-year routine follow up. An electronic version of the questionnaires will be administered on a tablet. The primary goal is to validate the clinical use of the German electronic version of the VascuQol-6 questionnaire to assess patient-related outcomes of the performed treatment by patients with PAD.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Other: Quality of life assessment - elective Other: Quality of life assessment - emergent

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Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Electronic Version of the VascuQoL-6 Questionnaire to Assess Patient Related Outcome Measures (ePROM) After Revascularization for Lower Limb Peripheral Arterial Disease in German-speaking Part of Switzerland
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Elective
Patients undergoing elective revascularisation (endovascular or surgical) for PAD.
 Other: Quality of life assessment - elective

Patients will be asked to fill up both VascuQoL-6 and SF-36 questionnaires before the procedure, as well at 30-days and 1-year follow-up visit while they are sitting in the waiting room. To assess reliability and systematic shift and variation between the two assessments, elective patients will be asked to fill the VascuQoL-6 again at the admission to hospital, as well as 1 week after the 30-days follow-up vie an e-mail link for a test-retest assessment. All questionnaires will be administered on a tablet.

During the 30-days follow-up 4 extra questions concerning patient related outcomes and occurrence of major complication will be added to the VascuQoL-6 questionnaire in the App. During every visit (preoperatively, at 30-days and 1-year follow-up) the stage of the lower limb peripheral artery disease will be noted according to the WIfI-Classification.
Emergent
Patients undergoing emergent revascularisation (endovascular or surgical) for PAD.
 Other: Quality of life assessment - emergent

Patients will be asked to fill up both VascuQoL-6 and SF-36 questionnaires before the procedure, as well at 30-days and 1-year follow-up visit while they are sitting in the waiting room. All questionnaires will be administered on a tablet.

During the 30-days follow-up 4 extra questions concerning patient related outcomes and occurrence of major complication will be added to the VascuQoL-6 questionnaire in the App. During every visit (preoperatively, at 30-days and 1-year follow-up) the stage of the lower limb peripheral artery disease will be noted according to the WIfI-Classification.


Outcome Measures
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Primary Outcome Measures :
  1. VascuQoL-6 Score [ Time Frame: baseline ]
    Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions

  2. VascuQoL-6 Score [ Time Frame: 1 Month after revascularisation ]
    Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions

  3. VascuQoL-6 Score [ Time Frame: 1 year after revascularisation ]
    Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions


Secondary Outcome Measures :
  1. WIfl classification [ Time Frame: baseline ]
    Wound, Ischemia and foot Infection Classification system - used to predict 1-year amputation risk and potential benefit of revascularization. The wound, limb Ischemia and foot infection are stratified and graded, thus creating a score.

  2. WIfl classification [ Time Frame: 1 month after revascularisation ]
    Wound, Ischemia and foot Infection Classification system - used to predict 1-year amputation risk and potential benefit of revascularization. The wound, limb Ischemia and foot infection are stratified and graded, thus creating a score.

  3. WIfl classification [ Time Frame: 1 year after revascularisation ]
    Wound, Ischemia and foot Infection Classification system - used to predict 1-year amputation risk and potential benefit of revascularization. The wound, limb Ischemia and foot infection are stratified and graded, thus creating a score.

  4. Complication rates [ Time Frame: 1 year ]
    Occurence of myocardial infarction, stroke or death

  5. Ankle-brachial indices [ Time Frame: baseline ]
    Ankle pressure to brachial pressure index, used to evaluate PAD

  6. Ankle-brachial indices [ Time Frame: 1 month after revascularisation ]
    Ankle pressure to brachial pressure index, used to evaluate PAD

  7. Ankle-brachial indices [ Time Frame: 1 year after revascularisation ]
    Ankle pressure to brachial pressure index, used to evaluate PAD

  8. Puls-plethysmography [ Time Frame: baseline ]
    Plethysmography is routine examination for PAD, allows for evaluation of extremity perfusion at different levels

  9. Puls-plethysmography [ Time Frame: 1 month after revascularisation ]
    Plethysmography is routine examination for PAD, allows for evaluation of extremity perfusion at different levels

  10. Puls-plethysmography [ Time Frame: 1 year after revascularisation ]
    Plethysmography is routine examination for PAD, allows for evaluation of extremity perfusion at different levels

  11. SF-36 Score [ Time Frame: baseline ]
    Short Form 36 Questionnaire - acknowledged tool for assesment of health related quality of life. Not disease specific, used as gold standard to evaluate the VascuQol-6 Questionnaire

  12. SF-36 Score [ Time Frame: 1 month after revascularisation ]
    Short Form 36 Questionnaire - acknowledged tool for assesment of health related quality of life. Not disease specific, used as gold standard to evaluate the VascuQol-6 Questionnaire

  13. SF-36 Score [ Time Frame: 1 year after revascularisation ]
    Short Form 36 Questionnaire - acknowledged tool for assesment of health related quality of life. Not disease specific, used as gold standard to evaluate the VascuQol-6 Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Volunteer native German-speakers with no cognitive impairment, by whom an elective or emergent revascularisation (endovascular or surgical) for lower limb peripheral artery disease has been indicated.
Criteria

Inclusion Criteria:

  • confirmed PAD
  • elective or emergent revascularization indicated (surgery/intervention)
  • native German speakers - no cognitive impairment

Exclusion Criteria:

  • not fulfilling any of the inclusion criteria
  • patients refusing to participate
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709107


Contacts
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Contact: Erika A Horvathova, MD +41787923040 erika.a.horvathova@gmail.com

Locations
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Switzerland
Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5000
Contact: Erika A Horvathova, MD    +41787923040    erika.a.horvathova@gmail.com   
Contact: Andrej Isaak, Dr. med.       andrej.isaak@ksa.ch   
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
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Study Director: Andrej Isaak, Dr. med. Kantonsspital Aarau
More Information
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Publications:
Conway K, et al. Linguistic validation of the vascular quality of life questionnaire (VASCUQOL) in 8 languages. Value in Health. 2000, 3(2):113.
Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfé N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8. Erratum in: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):492-493. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):158-159.

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Responsible Party: Andrej Isaak, Head of Vascular Surgery, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT04709107    
Other Study ID Numbers: 2020-00689
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrej Isaak, Kantonsspital Aarau:
peripheral arterial disease, pad, quality of life, ePROM, patient related outcome measures, HRQoL, health related quality of life
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases