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

ISRCTN ISRCTN14846962
DOI https://doi.org/10.1186/ISRCTN14846962
Secondary identifying numbers REK 2014/221
Submission date
29/05/2017
Registration date
31/05/2017
Last edited
26/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Anne Sofie Larsen
Public

Sykehuset Østfold HF
Avdeling for bildediagnostikk
Grålum
1714
Norway

ORCiD logoORCID ID 0000-0003-3408-7039
Dr Jarlis Wesche
Scientific

Akershus University Hospital
Lørenskog
1478
Norway

Study information

Study designObservational longitudinal study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet The patient participation information is in Norwegian, please use the contact details to request a patient information sheet
Scientific titleValidation of the Vascular Quality of Life-6 Questionnaire (VascuQoL-6) for use in patients with peripheral arterial disease
Study acronymVascuQoL-6
Study objectivesPatient 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(s)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
Health condition(s) or problem(s) studiedPeripheral arterial disease (PAD)
InterventionObservational 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 typeOther
Primary outcome measureVascular quality of life, measured using the VascuQoL-6 summary score at baseline and after 4 weeks and 1 year
Secondary outcome measures1. 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 study start date01/01/2014
Completion date01/01/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Total final enrolment171
Key inclusion criteria1. 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
Key exclusion criteriaPatients not suffering from peripheral arterial disease as primary explanation of symptoms (differential diagnosis)
Date of first enrolment01/08/2014
Date of final enrolment01/01/2016

Locations

Countries of recruitment

  • Norway

Study participating centres

Akerhus Universitetssykehus HF
Postbox 1000
Lørenskog
1478
Norway
Sykehuset Østfold HF
Grålum
1714
Norway

Sponsor information

Sykehuset Østfold HF
Hospital/treatment centre

Postboks 300
Grålum
1714
Norway

Email forskningsavdelingen@so-hf.no
ROR logo "ROR" https://ror.org/04wpcxa25

Funders

Funder type

Hospital/treatment centre

Sykehuset Østfold HF (Ostfold Hospital Trust)

No information available

Akershus Universitetssykehus HF (Akershus University Hospital)

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication of the results in a peer-reviewed open access journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anne Sofie Larsen.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/09/2017 13/07/2020 Yes No
Results article results 17/07/2020 26/08/2020 Yes No

Editorial Notes

26/08/2020: Publication reference added.
13/07/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.