Walking Impairment Questionnaire in PAD | NCT01114178

Studies
Walking Impairment Questionnaire in PAD

NCT01114178

Sponsor

University Hospital, Angers

Status

Terminated

Last Update Posted

Dec 19, 2016Estimated

Enrollment

340Actual

Phase

Not provided

Conditions

Peripheral Artery Disease

Interventions

questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment problem due to administrative process being too long

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 28, 2010

First Submission Date that Met QC Criteria

Apr 30, 2010

First Posted Date

May 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2016

Last Update Posted Date

Dec 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Questionnaires (WELCH and WIQ) submitted to patients referred for treadmill walking test Comparison of sore to MWD on treadmill. Comparison with WIQ will be performed

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
claudicants		patients referred for a treadmill test	Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	self completed questionnaire supervised by a technician	claudicants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
scoring of the WELCH questionnaire	predetermined score for the WELCH questionnaire answers (4 questions)	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent signed, french language fluent patients

Exclusion Criteria:

rejection of the questionnaire

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients referred for treadmill testing

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
denise Jolivot, MD	University Hospital	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25578404	Derived	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.
24445082

ID	Term
D058729	Peripheral Arterial Disease
D009043	Motor Activity

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms