NCT01114178

Brief Summary

Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

April 28, 2010

Last Update Submit

December 15, 2016

Conditions

Keywords

questionnaireperipheral artery diseaseexercise

Outcome Measures

Primary Outcomes (1)

  • scoring of the WELCH questionnaire

    predetermined score for the WELCH questionnaire answers (4 questions)

    1 day

Study Arms (1)

claudicants

patients referred for a treadmill test

Other: questionnaire

Interventions

self completed questionnaire supervised by a technician

claudicants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients referred for treadmill testing

You may qualify if:

  • informed consent signed, french language fluent patients

You may not qualify if:

  • rejection of the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, France

Location

Related Publications (4)

  • Fouasson-Chailloux A, Abraham P, Vielle B, Laporte I, Omarjee L, Ouedraogo N. The correlation of the "Walking Estimated-Limitation Calculated by History" (WELCH) questionnaire with treadmill maximal walking time is not impaired by age, in patients with claudication. Qual Life Res. 2015 Aug;24(8):1857-64. doi: 10.1007/s11136-015-0915-9. Epub 2015 Jan 13.

  • Abraham P, Godet R, Harbonnier M, Laneelle D, Leftheriotis G, Ouedraogo N. External validation of the "walking estimated limitation calculated by history" (WELCH) questionnaire in patients with claudication. Eur J Vasc Endovasc Surg. 2014 Mar;47(3):319-25. doi: 10.1016/j.ejvs.2013.11.010. Epub 2013 Dec 3.

  • Mahe G, Ouedraogo N, Marchand J, Vielle B, Picquet J, Leftheriotis G, Abraham P. Self-reported estimation of usual walking speed improves the performance of questionnaires estimating walking capacity in patients with vascular-type claudication. J Vasc Surg. 2011 Nov;54(5):1360-5. doi: 10.1016/j.jvs.2011.05.048.

  • Mahe G, Ouedraogo N, Vasseur M, Faligant C, Saidi K, Leftheriotis G, Abraham P. Limitations of self-reported estimates of functional capacity using the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):104-9. doi: 10.1016/j.ejvs.2010.10.002. Epub 2010 Nov 30.

MeSH Terms

Conditions

Peripheral Arterial DiseaseMotor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • denise Jolivot, MD

    University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 3, 2010

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations