Clinical trial NCT04709107: Validation of the VascuQoL-6 Questionnaire to Assess ePROM After Revascularization for Lower Limb Peripheral Arterial Disease in German-speaking Part of Switzerland
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease, pad, quality of life, ePROM, patient related outcome measures, HRQoL, health related quality of life
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: VascuQoL-6 Score
timeFrame: baseline
measure: VascuQoL-6 Score
timeFrame: 1 Month after revascularisation
measure: VascuQoL-6 Score
timeFrame: 1 year after revascularisation
Secondary outcomes:
measure: WIfl classification
timeFrame: baseline
measure: WIfl classification
timeFrame: 1 month after revascularisation
measure: WIfl classification
timeFrame: 1 year after revascularisation
measure: Complication rates
timeFrame: 1 year
measure: Ankle-brachial indices
timeFrame: baseline
measure: Ankle-brachial indices
timeFrame: 1 month after revascularisation
measure: Ankle-brachial indices
timeFrame: 1 year after revascularisation
measure: Puls-plethysmography
timeFrame: baseline
measure: Puls-plethysmography
timeFrame: 1 month after revascularisation
measure: Puls-plethysmography
timeFrame: 1 year after revascularisation
measure: SF-36 Score
timeFrame: baseline
measure: SF-36 Score
timeFrame: 1 month after revascularisation
measure: SF-36 Score
timeFrame: 1 year after revascularisation
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau
Study officials:
affiliation: Kantonsspital Aarau
name: Andrej Isaak, Dr. med.
role: STUDY_DIRECTOR
References:
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