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

Peripheral Arterial Disease Clinical Trial

— VascuQol6ValCH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709107
• Other study ID #: 2020-00689
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Kantonsspital Aarau
• Contact: Erika A Horvathova, MD
• Phone: +41787923040
• Email: erika.a.horvathova[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Lower extremity peripheral artery disease is a chronic illness that has a significant effect on the quality of life of the patients in short- as well as long-term.

Generic Instruments, such as widely used Medical Outcomes Study Short Form 36 questionnaire (SF-36) might be too insensitive to specific problems and associated comorbidities of vascular surgery patients as well as too complicated for routine use in a busy clinical setting. Therefore, the Vascular Quality of life questionnaire (VascuQoL-25) has been developed for use in the UK in 2001 at the Vascular Surgical Unit of King's College Hospital in London. To further simplify the use of the questionnaire, a lighter Version, that reduced the amount of asked questions from 25 to 6 (VascQuol-6) has been presented and found to be both valid and relevant. VascuQoL- 6 is a disease-specific questionnaire, developed to assess health-related quality of life (HRQoL) in patients with peripheral artery disease. It has been translated to 8 languages including German, and successfully validated for the use to assess in patients with peripheral artery disease in Sweden, Netherlands, Norway, Brazil and Poland.

In opinion of the investigators, a unified means to obtain relevant data concerning patient-related outcomes following treatment (endovascular or surgical) for PAD as part of existing aftercare schemes currently lacks in Switzerland. A simple tool such as VascuQoL-6 would allow collecting and objectively assessing, as well as comparing this kind of information after such procedures.

The main objective of the project is to validate the electronic version of the VascuQoL-6 for assessment of patient-related outcomes after a revascularization procedure (either surgical or interventional) for peripheral artery disease in the German-speaking part of Switzerland preoperatively, during the routine 30 days and a one-year follow-up.

Furthermore, upon the successful validation of the electronic VascuQoL-6, the investigators seek to implement the use of this easy to use, straight-forward tool in the follow-up scheme of the Swiss Vascular Registry (SwissVasc).

This project is of Risk A (minimum risk) according to art. 7 (HRO), because the patient-related quality of life will be evaluated after vascular surgery or intervention and will not have an influence on treatment modality.

Hypothesis and primary objective Assessment of quality regarding invasive treatment (endovascular or surgical), outcomes and patients satisfaction becomes a more and more powerful instrument to influence and guide decisions in the Swiss healthcare system. However, no unified means are currently being applied as part of the existing follow-up schema after revascularization for PAD in the German-speaking part of Switzerland. Therefore, the possibility to provide, assess, compare and use the information about short- mid- and long-term patient-related outcomes and improved/decreased disease- related quality of life in the decision-making process is limited.

Validation of a comprehensible and easy-to-use electronic Version of the VascuQoL-6 will allow obtaining such information in patients that underwent vascular/ endovascular surgery in the German-speaking part of Switzerland.

SwissVasc (i.e. Adjumed.net) is a nation-wide database to register vascular interventions and associated outcomes. Registration of individual data in SwissVasc (i.e. 30-day mortality, complication rate) is mandatory in Kanton Zurich and will become mandatory in Kanton Basel- Stadt and Basel-Landschaft in 2020. Moreover, this register will soon be part of the statutes of the Swiss Society of Vascular Surgery to evaluate the quality of training in each institution.

The Evaluation of VascuQoL-6 is part of this ambitious project. The goal is to implement the use of this questionnaire into the SwissVasc registry follow-up schema, to provide a uniformly used tool to collect and investigate the above-said information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

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. — View Citation

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. — View Citation

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

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. — View Citation

de Almeida Correia M, Andrade-Lima A, Mesquita de Oliveira PL, Domiciano RM, Ribeiro Domingues WJ, Wolosker N, Puench-Leão 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. — View Citation

Kumlien C, Nordanstig J, Lundström 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. — View Citation

Larsen ASF, Reiersen AT, Jacobsen MB, Kløw 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. — View Citation

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. — View Citation

Nordanstig J, Wann-Hansson C, Karlsson J, Lundström 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VascuQoL-6 Score	Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions	baseline
Primary	VascuQoL-6 Score	Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions	1 Month after revascularisation
Primary	VascuQoL-6 Score	Disease specific Questionnaire for peripheral arterial Disease, consists of 6 questions	1 year after revascularisation
Secondary	WIfl classification	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.	baseline
Secondary	WIfl classification	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.	1 month after revascularisation
Secondary	WIfl classification	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.	1 year after revascularisation
Secondary	Complication rates	Occurence of myocardial infarction, stroke or death	1 year
Secondary	Ankle-brachial indices	Ankle pressure to brachial pressure index, used to evaluate PAD	baseline
Secondary	Ankle-brachial indices	Ankle pressure to brachial pressure index, used to evaluate PAD	1 month after revascularisation
Secondary	Ankle-brachial indices	Ankle pressure to brachial pressure index, used to evaluate PAD	1 year after revascularisation
Secondary	Puls-plethysmography	Plethysmography is routine examination for PAD, allows for evaluation of extremity perfusion at different levels	baseline
Secondary	Puls-plethysmography	Plethysmography is routine examination for PAD, allows for evaluation of extremity perfusion at different levels	1 month after revascularisation
Secondary	Puls-plethysmography	Plethysmography is routine examination for PAD, allows for evaluation of extremity perfusion at different levels	1 year after revascularisation
Secondary	SF-36 Score	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	baseline
Secondary	SF-36 Score	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	1 month after revascularisation
Secondary	SF-36 Score	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	1 year after revascularisation