Plain English Summary
Background and study aims
Peripheral arterial disease (PAD) is a common condition where a build-up of fatty deposits in the arteries (blood vessels) restricts the blood supply to the leg muscles. The aim of this study is to test the Vascular Quality of Life-6 Questionnaire (VascuQoL-6) for assessing the quality of life of patients with peripheral arterial disease.
Who can participate?
Patients of any age with pain during walking, pain when at rest, or ulcers on their feet or legs
What does the study involve?
All participants complete the VascuQoL-6 questionnaire and their scores are compared to the scores from a longer form, as well as to measurements of the blood flow to the legs and to their walking capacity measured on a treadmill. Regardless of the treatment they receive, all participants are scheduled for two follow up appointments to repeat all of the measurements after 4 weeks and after 1 year.
What are the possible benefits and risks of participating?
The results from the study will indicate whether this questionnaire can be used for all patients. Participation in the study does not alter the treatment of the patient’s condition, and there is no risk involved.
Where is the study run from?
1. Sykehuset Østfold HF (Ostfold Hospital Trust) (Norway)
2. Akershus Universitetssykehus HF (Akershus University Hospital) (Norway)
When is the study starting and how long is it expected to run for?
January 2014 to January 2017
Who is funding the study?
1. Sykehuset Østfold HF (Ostfold Hospital Trust) (Norway)
2. Akershus Universitetssykehus HF (Akershus University Hospital) (Norway)
Who is the main contact?
1. Dr Anne Sofie Larsen (public)
2. Dr Jarlis Wesche
Trial website
Contact information
Type
Public
Primary contact
Dr Anne Sofie Larsen
ORCID ID
http://orcid.org/0000-0003-3408-7039
Contact details
Sykehuset Østfold HF
Avdeling for bildediagnostikk
Grålum
1714
Norway
Type
Scientific
Additional contact
Dr Jarlis Wesche
ORCID ID
Contact details
Akershus University Hospital
Lørenskog
1478
Norway
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REK 2014/221
Study information
Scientific title
Validation of the Vascular Quality of Life-6 Questionnaire (VascuQoL-6) for use in patients with peripheral arterial disease
Acronym
VascuQoL-6
Study hypothesis
Patient reported outcome (PROM) is very important in patients suffering from peripheral arterial disease (PAD), as the current available outcome measures of systolic arterial pressure measurements and walking capacity do not reflect the patient experience after treatment, especially for patients suffering from the milder forms of the disease (intermittent claudication). VascuQoL-6 is designed as a PROM intended for vascular procedural registries and clinical practice, but has not yet been validated. The aim of the study is to evaluate how VascuQoL-6 performs as a disease-specific Quality of Life instrument in a unselected patient population with PAD in secondary health care.
Ethics approval
Regional Committees of Medical and Health Research Ethics (in Norway), South East Office, date of approval 25/03/2014, minor alteration 11/05/2015, ref: REK 2014/221
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
The patient participation information is in Norwegian, please use the contact details to request a patient information sheet
Condition
Peripheral arterial disease (PAD)
Intervention
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 approach. The patients complete the generic health status instrument SF-36 and VascuQoL-6 prior to each consultation. Data from the vascular laboratory (systolic arterial pressure measurements and treadmill performance) and from the clinical consultation by the vascular surgeon are used as anchors. Correlation analysis and internal consistency are calculated from baseline data. Reliability is evaluated after 4 weeks in patients without invasive treatment, and responsiveness to change is evaluated in patients who receive invasive treatment.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Vascular quality of life, measured using the VascuQoL-6 summary score at baseline and after 4 weeks and 1 year
Secondary outcome measures
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
Overall trial start date
01/01/2014
Overall trial end date
01/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Patients not suffering from peripheral arterial disease as primary explanation of symptoms (differential diagnosis)
Recruitment start date
01/08/2014
Recruitment end date
01/01/2016
Locations
Countries of recruitment
Norway
Trial participating centre
Akerhus Universitetssykehus HF
Postbox 1000
Lørenskog
1478
Norway
Trial participating centre
Sykehuset Østfold HF
Grålum
1714
Norway
Sponsor information
Organisation
Sykehuset Østfold HF
Sponsor details
Postboks 300
Grålum
1714
Norway
-
forskningsavdelingen@so-hf.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sykehuset Østfold HF (Ostfold Hospital Trust)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Akershus Universitetssykehus HF (Akershus University Hospital)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication of the results in a peer-reviewed open access journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anne Sofie Larsen.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list