Walking Estimated Limitation Calculated by History - Study 2 (WELCH-2)
This study is currently recruiting participants.
Verified September 2012 by University Hospital, Angers
Sponsor:
University Hospital, Angers
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01424020
First received: August 23, 2011
Last updated: September 29, 2012
Last verified: September 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 23, 2011 | ||||||||
| Last Updated Date | September 29, 2012 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
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 questions); (4 additions & 1 multiplication)]and WIQ... estimation of the percentage of errors with 95% confidence interval. Comparison of the two percentages |
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| Change History | Complete list of historical versions of study NCT01424020 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Walking Estimated Limitation Calculated by History - Study 2 | ||||||||
| Official Title ICMJE | Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs | ||||||||
| 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. |
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| 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) |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE | Peripheral Artery Disease | ||||||||
| Intervention ICMJE | 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:
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| Study Group/Cohort (s) | suspected PAD patients
Patients suspected of peripheral artery disease and, as such, referred for a vascular investigations
Intervention: Other: Questionnaire |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: previous inclusion in the protocole is note an exclusion criterion for a new participation. |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01424020 | ||||||||
| Other Study ID Numbers ICMJE | CHU-P 2011-06 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Angers | ||||||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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