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Optimized Supervised Education Program for Peripheral Arterial Disease (POPART)

This study is currently recruiting participants.
Verified December 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01065740
First received: February 8, 2010
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
 Other: Patient education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 6 minutes walking test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: Patient education
No Intervention: Usual care

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065740

Contacts
Contact: Caroline Dourmap-Collas, MD 0033299282508 caroline.dourmap-collas@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Caroline Dourmap-Collas, MD     0033299282508     caroline.dourmap-collas@chu-rennes.fr    
Principal Investigator: Caroline Dourmap-Collas, MD            
Sponsors and Collaborators
Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01065740     History of Changes
Other Study ID Numbers: phrq/09-01
Study First Received: February 8, 2010
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Peripheral arterial disease
Patient education
Physical activity coaching
 Lifestyle modifications
Walking capacity
6 minutes walking test

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013