Peripheral Arterial DiseasePOPARTNCT01065740
Optimized Supervised Education Program for Peripheral Arterial Disease
A study testing Patient education in people with Peripheral Arterial Disease, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years
- With peripheral arterial disease
- Who accept to follow a patient education program
Who cannot join
- Permanent limb ischemia
- Revascularisation programmed in the 6 next months
- Other severe prognostic disease
- Difficulties to obtain patient consent because of language or understanding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Patient education
- Keywords
- Peripheral arterial disease, Patient education, Physical activity coaching, Lifestyle modifications, Walking capacity, 6 minutes walking test
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
| Study group | Role | What they receive |
|---|---|---|
| patient education | Experimental | 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 Receives: Other: Patient education |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2015
- Study completionFeb 2016
Why it stopped: Recruitment Difficulties and Financing Limited and exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065740
- Sponsor's protocol ID
- phrq/09-01
- Acronym
- POPART
- Status last verified
- Jun 2016
- First submitted
- 8 Feb 2010
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Supervised Education Program for Peripheral Arterial Disease: Ambulatory Management With Patient Education
- ClinicalTrials.gov ID
- NCT01065740
- Acronym / sponsor ID
- POPART / phrq/09-01
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease, Patient education, Physical activity coaching, Lifestyle modifications, Walking capacity, 6 minutes walking test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment Difficulties and Financing Limited and exhausted
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient education | Experimental | Other: Patient educationindividual 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 |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 75 years
- With peripheral arterial disease
- Who accept to follow a patient education program
Key exclusion criteria (4 listed)
- Permanent limb ischemia
- Revascularisation programmed in the 6 next months
- Other severe prognostic disease
- Difficulties to obtain patient consent because of language or understanding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education | Other | patient education |
Primary outcome
6 minutes walking test
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment Difficulties and Financing Limited and exhausted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Peripheral Arterial Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment Difficulties and Financing Limited and exhausted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.