Socioeconomic Deprivation and Peripheral Arterial Disease

NCT03693053 | Completed

• 2 other identifiers: 38RC17.2122017-A02063-50
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Atherosclerosis is a systemic disease that affects coronary, cerebral, and lower-extremity arteries. Peripheral artery disease (PAD) is the manifestation of atherosclerosis in the legs. Three different stages can be found: asymptomatic stage (stage 1), exercise ischemia stage (stage 2) and rest ischemia stage (stage 3). The risk factors for PAD are similar to those for coronary artery disease (CAD) and cerebrovascular disease (CBVD), like high blood pressure, diabetes, smoking, dyslipidemia and obesity. But cigarette smoking is the single most important risk factor for the development and progression of PAD. PAD is a serious illness and an important predictor of cardiovascular disease with major medico-economic consequences. A low socioeconomic status (SES) is associated with higher cardiovascular mortality and morbidity. In these vulnerable populations, there is an increase in the prevalence of cardiovascular risk factors, particularly for smoking. The main objective of this study was to assess the level of precariousness in patients with symptomatic PAD and compare it to the level of precariousness in the general population. Patients were recruited from vascular medicine and surgery department of Grenoble university hospital or therapeutic education outpatient consultation. The analysis of socio-economic and environmental data resulted in: \- EPICES score: (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centers score). The EPICES score is a quick and validated questionnaire to assess precariousness at the individual level, developed by considering all the material and psychosocial dimensions of precariousness. Precariousness, according to the EPICES score, in the general population is estimated at 40%. \- INSEE parameters. The investigators completed the EPICES score with more traditional indicators derived from The National Institute of Statistics and Economic Studies (INSEE) collects, analyses and disseminates information on the French economy and society. The investigators collected the level of education and professional practice based on the nomenclature of socio-professional categories defined by INSEE. Cardiovascular risk factors were also collected to measure the links between the level of precariousness and cardiovascular risk factors.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Level of precariousness in patients with symptomatic PAD

  The level of precariousness is measured by EPICES score : It consists of 11 items related to isolation, health insurance status, economic status, social support and leisure activity. For each item, a binary response Yes/No is expected from the patient. The total score ranges from 0 to 100, from lack to the highest social deprivation. Patients were considered precarious if their score is superior to threshold of 30.

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Secondary Outcomes (2)

• Level of precariousness by EPICES score between stage 2 and stage 3 of symptomatic PAD.

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• Links between the level of precariousness by EPICES score and cardiovascular risk factors.

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Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited from * Vascular medicine and surgery department of Grenoble university hospital * Or therapeutic education consultation. These consultations took place in Grenoble reference center of therapeutic education CREPvAL Granted as part of education program: "On the move! Better understand and better live your PAD".

You may qualify if:

• Male or female,
• Age 18 years or older,
• Symptomatic PAD (stage 2 or 3)

You may not qualify if:

• Pregnant woman
• Person under administrative or judicial supervision

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital

Grenoble, Isere, 38000, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: October 2, 2018
• Study Start: October 2, 2017
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)