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Quality of life in patients with peripheral arterial disease: the Vascular Quality of Life-6 Questionnaire (VascuQoL-6) study

Validation of the Vascular Quality of Life-6 Questionnaire (VascuQoL-6) for use in patients with peripheral arterial disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14846962
Enrollment
200
Registered
2017-05-31
Start date
2014-08-01
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease (PAD) Circulatory System

Interventions

Observational longitudinal cohort from two secondary health care centres with observation at inclusion, after 4 weeks and 1 year. Validation of the VascuQoL-6 questionnaire is done by an anchor-based

Sponsors

Sykehuset Østfold HF
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients referred to the department of vascular surgery at the participating hospitals for evaluation of potential or established peripheral arterial disease, regardless of age or gender 2. Eligibility is decided by the vascular surgeon evaluating the referral documents from physicians in primary health care. Information about the study and invitation to participate will be issued with the appointment details 3. Consecutive inclusion of patients with exclusion if the diagnostic work up do not indicate peripheral arterial disease

Exclusion criteria

Exclusion criteria: Patients not suffering from peripheral arterial disease as primary explanation of symptoms (differential diagnosis)

Design outcomes

Primary

MeasureTime frame
Vascular quality of life, measured using the VascuQoL-6 summary score at baseline and after 4 weeks and 1 year

Secondary

MeasureTime frame
1. Generic health status, measured using SF-36 2. Ankle-brachial index (ABI), measured using handheld Doppler and circular cuff at the ankle at rest and after exercise 3. Walking capacity, measured on a treadmill (2.5 km/h, 0 degrees of incline) for a maximum of 10 minutes 4. Peripheral artery disease clinical evaluation, using the Rutherford/Fontaine clinical classification systems Measured at baseline and after 4 weeks and 1 year

Countries

Norway

Contacts

Public ContactAnne Sofie Larsen

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026