Condition category
Circulatory System
Date applied
29/05/2017
Date assigned
31/05/2017
Last edited
30/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes