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Walking Estimated Limitation Calculated by History - Study 2 (WELCH-2)

Primary Purpose

Peripheral Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Artery Disease focused on measuring Questionnaire, peripheral artery disease, execise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.

Sites / Locations

  • Vascular investigationRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • RehabilitationRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • RehabilitationRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular Medicine
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting
  • Vascular MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

questionnaire

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation with ankle brachial index (ABI)
Analysis of first inclusion only in patients that are included multiple times over the study period. Calculation of questionnaire scores from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to minimal ABI
Correlation with treadmill result
Analysis of first inclusion only in patients that are included multiple times over the study period.Calculation of questionnaires score from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to maximal walking distance on treadmill, in the subgroup of patients that have a routine treadmill scheduled during the visit.
Facility of the scoring of the questionnaires
Proportion of WELCH scores calculated by physician and comparison to the proportion of WIQ score calculated by physicians as a estimation of the facility to calculate the score by mental calculation in routine
Reliability of the questionnaire
Comparison of the scores of the WELCH in the patients that may be seens within 3 weeks of their first inclusion, for any reasons, (e.i. seen first for a doppler and two weeks later for a treadmill test)over the study period. Analysis of the reliability through the coefficient of variation of the score.
sensitivity of the WELCH to changes
Comparison of the scores of the WELCH in the patients that may be seens within 1 year from their first inclusion, for any reasons, (e.i. seen follow up of their disease)over the study period. Analysis of the changes of the score to changes of the ABI. Analysis of the changes of the score to changes in maximal walking distance if available.

Full Information

First Posted
August 23, 2011
Last Updated
December 15, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01424020
Brief Title
Walking Estimated Limitation Calculated by History - Study 2
Acronym
WELCH-2
Official Title
Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Two questionnaires the WELCH and the "walking impairment questionnaire" (WIQ) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (PAD). Comparison of score to hemodynamic parameters (first goal) or maximal walking distance (MWD) on treadmill (secondary goal). Scoring of the WIQ is performed according to references. Scoring of the WELCH has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Questionnaire, peripheral artery disease, execise

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
questionnaire
Arm Type
Experimental
Arm Description
Patients suspected of peripheral artery disease and, as such, referred for a vascular investigations and submitted the WELCH questionnaire
Intervention Type
Other
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Walking impairment questionnaire (WIQ), Walking estimated limitation calculated by history (WELCH)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Proportion of questionnaires with errors after self completion
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Correlation with ankle brachial index (ABI)
Description
Analysis of first inclusion only in patients that are included multiple times over the study period. Calculation of questionnaire scores from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to minimal ABI
Time Frame
1 day
Title
Correlation with treadmill result
Description
Analysis of first inclusion only in patients that are included multiple times over the study period.Calculation of questionnaires score from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to maximal walking distance on treadmill, in the subgroup of patients that have a routine treadmill scheduled during the visit.
Time Frame
1 day
Title
Facility of the scoring of the questionnaires
Description
Proportion of WELCH scores calculated by physician and comparison to the proportion of WIQ score calculated by physicians as a estimation of the facility to calculate the score by mental calculation in routine
Time Frame
1 day
Title
Reliability of the questionnaire
Description
Comparison of the scores of the WELCH in the patients that may be seens within 3 weeks of their first inclusion, for any reasons, (e.i. seen first for a doppler and two weeks later for a treadmill test)over the study period. Analysis of the reliability through the coefficient of variation of the score.
Time Frame
3 weeks
Title
sensitivity of the WELCH to changes
Description
Comparison of the scores of the WELCH in the patients that may be seens within 1 year from their first inclusion, for any reasons, (e.i. seen follow up of their disease)over the study period. Analysis of the changes of the score to changes of the ABI. Analysis of the changes of the score to changes in maximal walking distance if available.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: French Native language 18 years old or older Signed consent Covered by the French social care system Exclusion Criteria: Unable to participate for administrative reasons Psychiatric troubles Pain at rest or critical limb ischemia Unable to walk (ex: wheelchair subjects) Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Abraham, MD; PhD
Phone
33 (0) 2 41 35 36 89
Email
piabraham@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Johann Marchand, MD
Email
welch@gernigon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ABRAHAM, MD; PhD
Organizational Affiliation
University Hospital in Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular investigation
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GEORGES LEFTHERIOTIS, MD
First Name & Middle Initial & Last Name & Degree
MARIE-SOPHIE LEGRAND, MD
First Name & Middle Initial & Last Name & Degree
GUILLAUME MAHE, MD
First Name & Middle Initial & Last Name & Degree
GEOFFROY PERDREAU, MD
Facility Name
Vascular Medicine
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam MARTIN, MD
Facility Name
Vascular Medicine
City
Aubenas
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam CHANUT, MD
Facility Name
Rehabilitation
City
Ballan Mire
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine VOYER, MD
First Name & Middle Initial & Last Name & Degree
Marion AUBOURG, MD
Facility Name
Vascular Medicine
City
Belfort
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude NICOL, MD
Facility Name
Vascular Medicine
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire LE HELLO, MD
Facility Name
Vascular Medicine
City
Castanet Tolosan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joëlle LAFFONT, MD
Facility Name
Vascular Medicine
City
Champagnole
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle BUFFARD, MD
Facility Name
Vascular Medicine
City
Chazelles Sur Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjolaine BASSET-NEEL, MD
Facility Name
Rehabilitation
City
Hauteville
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario MAUFUS, MD
Facility Name
Vascular Medicine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aïssa SANOGO, MD
Facility Name
Vascular Medicine
City
Perigueux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudette DELHOUME, MD
Facility Name
Vascular Medicine
City
Perpignan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria DOAS, MD
Facility Name
Vascular Medicine
City
Reims
Country
France
Individual Site Status
Suspended
Facility Name
Vascular Medicine
City
Sallanches
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-François GOY, MD
Facility Name
Vascular Medicine
City
Tarbes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine CLEDAT-WENDEL, MD
Facility Name
Vascular Medicine
City
Villenave d'Ornon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie SKOPINSKI, Md
Facility Name
Vascular Medicine
City
Wattrelos
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henic HIDDEN, MD

12. IPD Sharing Statement

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Walking Estimated Limitation Calculated by History - Study 2

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