Optimized Supervised Education Program for Peripheral Art... | NCT01065740

Studies
Optimized Supervised Education Program for Peripheral Arterial Disease

NCT01065740

Sponsor

Rennes University Hospital

Status

Terminated

Last Update Posted

Jun 27, 2016Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Peripheral Arterial Disease

Interventions

Patient education

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment Difficulties and Financing Limited and exhausted

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

Feb 8, 2010

First Submission Date that Met QC Criteria

Feb 8, 2010

First Posted Date

Feb 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2016

Last Update Posted Date

Jun 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: Patient education
Usual care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient education	Other		patient education

Measure	Description	Time Frame
6 minutes walking test		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rennes University Hospital		Rennes		35033	France

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010353	Patient Education as Topic

Ancestor Terms

ID	Term
D006266	Health Education
D011314	Preventive Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided