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Optimized Supervised Education Program for Peripheral Arterial Disease (POPART)

This study has been terminated.
(Recruitment Difficulties and Financing Limited and exhausted)
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01065740
First received: February 8, 2010
Last updated: June 24, 2016
Last verified: June 2016

February 8, 2010
June 24, 2016
February 2010
February 2015   (final data collection date for primary outcome measure)
6 minutes walking test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065740 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optimized Supervised Education Program for Peripheral Arterial Disease
Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Arterial Disease
Other: Patient education
  • Experimental: patient education
    individual and group meetings with explanations about the disease, lifestyle counseling ; coaching by phone at 1 and 4 months; medical consultation at 3 months; physical exercise with coaching
    Intervention: Other: Patient education
  • No Intervention: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
February 2016
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01065740
phrq/09-01
Yes
Not Provided
Not Provided
Rennes University Hospital
Rennes University Hospital
Not Provided
Not Provided
Rennes University Hospital
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP