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

NCT04709107 | Unknown

• 1 other identifier: 2020-00689
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease, pad, quality of life, ePROM, patient related outcome measures, HRQoL, health related quality of life

Outcome Measures

Primary Outcomes (3)

• VascuQoL-6 Score

  Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions

  baseline

• VascuQoL-6 Score

  Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions

  1 Month after revascularisation

• VascuQoL-6 Score

  Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions

  1 year after revascularisation

Secondary Outcomes (13)

• WIfl classification

  baseline

• WIfl classification

  1 month after revascularisation

• WIfl classification

  1 year after revascularisation

• Complication rates

  1 year

• Ankle-brachial indices

  baseline

Study Arms (2)

Elective

Patients undergoing elective revascularisation (endovascular or surgical) for PAD.

Other: Quality of life assessment - elective

Emergent

Patients undergoing emergent revascularisation (endovascular or surgical) for PAD.

Other: Quality of life assessment - emergent

Interventions

Quality of life assessment - elective OTHER

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.

Elective

Quality of life assessment - emergent OTHER

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.

Emergent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• patients refusing to participate

Sponsors & Collaborators

• Kantonsspital Aarau: lead

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5000, Switzerland

RECRUITING

Related Publications (10)

• Morgan 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.

  PMID: 11296317 BACKGROUND

• Nordanstig 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.

  PMID: 24342060 BACKGROUND

• Conway K, et al. Linguistic validation of the vascular quality of life questionnaire (VASCUQOL) in 8 languages. Value in Health. 2000, 3(2):113.

  BACKGROUND

• Kumlien C, Nordanstig J, Lundstrom M, Pettersson M. Validity and test retest reliability of the vascular quality of life Questionnaire-6: a short form of a disease-specific health-related quality of life instrument for patients with peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 29;15(1):187. doi: 10.1186/s12955-017-0762-1.

  PMID: 28962624 BACKGROUND

• Larsen 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.

  PMID: 28938901 BACKGROUND

• de 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.

  PMID: 29772330 BACKGROUND

• Belowski A, Partyka L, Krzanowski M, Polczyk R, Maga P, Maga M, Acquadro C, Lambe J, Morgan M, Nizankowski R. Clinical and linguistic validation of the Polish version of VascuQol: a disease-specific quality-of-life questionnaire assessing patients with chronic limb ischemia. Pol Arch Intern Med. 2019 Mar 29;129(3):167-174. doi: 10.20452/pamw.4455. Epub 2019 Feb 22.

  PMID: 30793704 BACKGROUND

• 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, Chakfe 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.

  PMID: 31182334 BACKGROUND

• Cull DL, Manos G, Hartley MC, Taylor SM, Langan EM, Eidt JF, Johnson BL. An early validation of the Society for Vascular Surgery lower extremity threatened limb classification system. J Vasc Surg. 2014 Dec;60(6):1535-41. doi: 10.1016/j.jvs.2014.08.107. Epub 2014 Oct 3.

  PMID: 25282695 BACKGROUND

• Zhan LX, Branco BC, Armstrong DG, Mills JL Sr. The Society for Vascular Surgery lower extremity threatened limb classification system based on Wound, Ischemia, and foot Infection (WIfI) correlates with risk of major amputation and time to wound healing. J Vasc Surg. 2015 Apr;61(4):939-44. doi: 10.1016/j.jvs.2014.11.045. Epub 2015 Feb 2.

  PMID: 25656592 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrej Isaak, Dr. med.

  Kantonsspital Aarau

  STUDY DIRECTOR

Central Study Contacts

Erika A Horvathova, MD

CONTACT

+41787923040; erika.a.horvathova@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Vascular Surgery

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 14, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CH (1)