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NCT01065740 Clinical Trial

Optimized Supervised Education Program for Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— POPART  

Official title:
Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01065740
Other study ID # phrq/09-01
Secondary ID
Status Terminated
Phase N/A
First received February 8, 2010
Last updated June 24, 2016
Start date February 2010
Est. completion date February 2016

Study information
Verified date June 2016
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Peripheral arterial disease (PAD) is a frequent and serious chronic disease witch is undertreated. The recommended management of PAD include pharmacological approach and lifestyle modifications. Patient education help to reach this outcome. Our study propose to compare patient education management with physical activity coaching to usual care.

Recruitment information / eligibility
Status Terminated
Enrollment 64
Est. completion date February 2016
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients aged 18 to 75 years

- With peripheral arterial disease

- Who accept to follow a patient education program

Exclusion Criteria:

- Permanent limb ischemia

- Revascularisation programmed in the 6 next months

- Other severe prognostic disease

- Difficulties to obtain patient consent because of language or understanding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Patient education

Locations
Country Name City State
France Rennes University Hospital Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6 minutes walking test 6 months No
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