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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
  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:


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 ]

Enrollment: 64
Study Start Date: February 2010
Study Completion Date: February 2016
Primary Completion Date: February 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
  More Information

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: June 24, 2016
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 December 05, 2016