Walking Estimated Limitation Calculated by History - Study 2 - Full Text View

Purpose

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.

Condition	Intervention
Peripheral Artery Disease	Other: Questionnaire

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:

Proportion of questionnaires with errors after self completion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	800
Study Start Date:	September 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
suspected PAD patients Patients suspected of peripheral artery disease and, as such, referred for a vascular investigations	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)

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients referred for arterial vascular investigation regardless of whether they are prooved for peripheral arterial disease, or not.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424020

Contacts

Contact: Pierre Abraham, MD; PhD	33 (0) 2 41 35 36 89	piabraham@chu-angers.fr
Contact: Johann Marchand, MD		welch@gernigon.fr

Locations

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

Sponsors and Collaborators

University Hospital, Angers

Investigators

Principal Investigator:

Pierre ABRAHAM, MD; PhD

University Hospital in Angers

More Information

No publications provided

Responsible Party:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT01424020 History of Changes
Other Study ID Numbers:	CHU-P 2011-06
Study First Received:	August 23, 2011
Last Updated:	September 29, 2012
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Angers:

Questionnaire
peripheral artery disease
execise

Additional relevant MeSH terms:

Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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