Back to resultsOptimized Supervised Education Program for Peripheral Arterial Disease (POPART)
Primary Purpose
Peripheral Arterial Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient education
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Patient education, Physical activity coaching, Lifestyle modifications, Walking capacity, 6 minutes walking test
Eligibility 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
Sites / Locations
- Rennes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
patient education
Usual care
Arm Description
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
Outcomes
Primary Outcome Measures
6 minutes walking test
Secondary Outcome Measures
Full Information
NCT ID
NCT01065740
First Posted
February 8, 2010
Last Updated
June 24, 2016
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01065740
Brief Title
Optimized Supervised Education Program for Peripheral Arterial Disease
Acronym
POPART
Official Title
Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment Difficulties and Financing Limited and exhausted
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral arterial disease, Patient education, Physical activity coaching, Lifestyle modifications, Walking capacity, 6 minutes walking test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient education
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Patient education
Primary Outcome Measure Information:
Title
6 minutes walking test
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
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Optimized Supervised Education Program for Peripheral Arterial Disease
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