- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065740
Optimized Supervised Education Program for Peripheral Arterial Disease (POPART)
June 24, 2016 updated by: Rennes University Hospital
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rennes, France, 35033
- Rennes University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6 minutes walking test
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
February 8, 2010
First Submitted That Met QC Criteria
February 8, 2010
First Posted (Estimate)
February 9, 2010
Study Record Updates
Last Update Posted (Estimate)
June 27, 2016
Last Update Submitted That Met QC Criteria
June 24, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- phrq/09-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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University of MalayaCompletedPressure Injury | Limitation, MobilityMalaysia
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Trakya UniversityCompletedPain | Pain Management | Fear of Pain | Patient EducationTurkey
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Riphah International UniversityCompletedPulmonary Arterial HypertensionPakistan
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Aarhus University HospitalNovo Nordisk A/S; TrygFonden, Denmark; Aalborg University Hospital; Horsens Hospital and other collaboratorsActive, not recruitingRheumatoid Arthritis | Self Efficacy | Patient InvolvementDenmark