NCT01065740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

5 years

First QC Date

February 8, 2010

Last Update Submit

June 24, 2016

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial diseasePatient educationPhysical activity coachingLifestyle modificationsWalking capacity6 minutes walking test

Outcome Measures

Primary Outcomes (1)

  • 6 minutes walking test

    6 months

Study Arms (2)

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

Patient educationOTHER
patient education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 75 years
  • With peripheral arterial disease
  • Who accept to follow a patient education program

You may not qualify if:

  • Permanent limb ischemia
  • Revascularisation programmed in the 6 next months
  • Other severe prognostic disease
  • Difficulties to obtain patient consent because of language or understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

FR(1)