NCT01424020

Brief Summary

The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_4

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

6.2 years

First QC Date

August 23, 2011

Last Update Submit

December 15, 2016

Conditions

Peripheral Artery Disease

Keywords

Questionnaireperipheral artery diseaseexecise

Outcome Measures

Primary Outcomes (1)

  • Proportion of questionnaires with errors after self completion

    Analysis of first inclusion only in patients that are included multiple times over the study period. Predetermined score for the WELCH questionnaire answers \[(4 items); (4 additions \& 1 multiplication)\] and WIQ... estimation of the percentage of errors with 95% confidence interval. Comparison of the two percentages

    1 day

Secondary Outcomes (5)

  • Correlation with ankle brachial index (ABI)

    1 day

  • Correlation with treadmill result

    1 day

  • Facility of the scoring of the questionnaires

    1 day

  • Reliability of the questionnaire

    3 weeks

  • sensitivity of the WELCH to changes

    1 year

Study Arms (1)

questionnaire

EXPERIMENTAL

Patients suspected of peripheral artery disease and, as such, referred for a vascular investigations and submitted the WELCH questionnaire

Other: Questionnaire

Interventions

QuestionnaireOTHER

Self completed questionnaire, Supervised by the physician Ankle brachial index (ABI) calculation Maximal walking distance (MWD) on treadmill or over the 6 minutes walking test (when available)

Also known as: Walking impairment questionnaire (WIQ), Walking estimated limitation calculated by history (WELCH)
questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • French Native language
  • years old or older
  • Signed consent
  • Covered by the French social care system

You may not qualify if:

  • Unable to participate for administrative reasons
  • Psychiatric troubles
  • Pain at rest or critical limb ischemia
  • Unable to walk (ex: wheelchair subjects)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Vascular investigation

Angers, France

RECRUITING

Vascular Medicine

Annecy, France

RECRUITING

Vascular Medicine

Aubenas, France

RECRUITING

Rehabilitation

Ballan-Miré, France

RECRUITING

Vascular Medicine

Belfort, France

RECRUITING

Vascular Medicine

Caen, France

RECRUITING

Vascular Medicine

Castanet-Tolosan, France

RECRUITING

Vascular Medicine

Champagnole, France

RECRUITING

Vascular Medicine

Chazelles-sur-Lyon, France

RECRUITING

Rehabilitation

Hauteville, France

RECRUITING

Vascular Medicine

Paris, France

RECRUITING

Vascular Medicine

Perpignan, France

RECRUITING

Vascular Medicine

Périgueux, France

RECRUITING

Vascular Medicine

Reims, France

SUSPENDED

Vascular Medicine

Sallanches, France

RECRUITING

Vascular Medicine

Tarbes, France

RECRUITING

Vascular Medicine

Villenave-d'Ornon, France

RECRUITING

Vascular Medicine

Wattrelos, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pierre ABRAHAM, MD; PhD

    University Hospital in Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Abraham, MD; PhD

CONTACT

33 (0) 2 41 35 36 89piabraham@chu-angers.fr

Johann Marchand, MD

CONTACT

welch@gernigon.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations

FR(18)