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

December 15, 2016 updated by: University Hospital, Angers

Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • Vascular investigation
        • Sub-Investigator:
          • GUILLAUME MAHE, MD
        • Sub-Investigator:
          • GEORGES LEFTHERIOTIS, MD
        • Sub-Investigator:
          • MARIE-SOPHIE LEGRAND, MD
        • Sub-Investigator:
          • GEOFFROY PERDREAU, MD
      • Annecy, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Myriam MARTIN, MD
      • Aubenas, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Myriam CHANUT, MD
      • Ballan Mire, France
        • Recruiting
        • Rehabilitation
        • Sub-Investigator:
          • Carine VOYER, MD
        • Sub-Investigator:
          • Marion AUBOURG, MD
      • Belfort, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Claude NICOL, MD
      • Caen, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Claire LE HELLO, MD
      • Castanet Tolosan, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Joëlle LAFFONT, MD
      • Champagnole, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Danielle BUFFARD, MD
      • Chazelles Sur Lyon, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Marjolaine BASSET-NEEL, MD
      • Hauteville, France
        • Recruiting
        • Rehabilitation
        • Sub-Investigator:
          • Mario MAUFUS, MD
      • Paris, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Aïssa SANOGO, MD
      • Perigueux, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Claudette DELHOUME, MD
      • Perpignan, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Maria DOAS, MD
      • Reims, France
        • Suspended
        • Vascular Medicine
      • Sallanches, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Pierre-François GOY, MD
      • Tarbes, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Catherine CLEDAT-WENDEL, MD
      • Villenave d'Ornon, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Sophie SKOPINSKI, Md
      • Wattrelos, France
        • Recruiting
        • Vascular Medicine
        • Sub-Investigator:
          • Henic HIDDEN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: questionnaire
Patients suspected of peripheral artery disease and, as such, referred for a vascular investigations and submitted the WELCH questionnaire
Other: Questionnaire
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)
Other Names:
  • Walking impairment questionnaire (WIQ)
  • Walking estimated limitation calculated by history (WELCH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of questionnaires with errors after self completion
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with ankle brachial index (ABI)
Time Frame: 1 day
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
1 day
Correlation with treadmill result
Time Frame: 1 day
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.
1 day
Facility of the scoring of the questionnaires
Time Frame: 1 day
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
1 day
Reliability of the questionnaire
Time Frame: 3 weeks
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.
3 weeks
sensitivity of the WELCH to changes
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Pierre ABRAHAM, MD; PhD, University Hospital in Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-P 2011-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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