Walking Estimated Limitation Calculated by History - Study 2

Peripheral Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01424020
• Other study ID #: CHU-P 2011-06
• Status: Recruiting
• Phase: Phase 4
• First received: August 23, 2011
• Last updated: December 15, 2016
• Start date: September 2011
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: University Hospital, Angers
• Contact: Pierre Abraham, MD; PhD
• Phone: 33 (0) 2 41 35 36 89
• Email: piabraham[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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)

Locations

Country	Name	City	State
France	Vascular investigation	Angers
France	Vascular Medicine	Annecy
France	Vascular Medicine	Aubenas
France	Rehabilitation	Ballan Mire
France	Vascular Medicine	Belfort
France	Vascular Medicine	Caen
France	Vascular Medicine	Castanet Tolosan
France	Vascular Medicine	Champagnole
France	Vascular Medicine	Chazelles Sur Lyon
France	Rehabilitation	Hauteville
France	Vascular Medicine	Paris
France	Vascular Medicine	Perigueux
France	Vascular Medicine	Perpignan
France	Vascular Medicine	Reims
France	Vascular Medicine	Sallanches
France	Vascular Medicine	Tarbes
France	Vascular Medicine	Villenave d'Ornon
France	Vascular Medicine	Wattrelos

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day	No
Secondary	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	1 day	No
Secondary	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.	1 day	No
Secondary	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	1 day	No
Secondary	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.	3 weeks	No
Secondary	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.	1 year	No