ANPSYSOMEVAD: Anthropometric and Psychosocial Measurements in Vascular Disease

Sponsor
University of Catanzaro (Other)
Overall Status
Recruiting
CT.gov ID
NCT05472480
Collaborator
(none)
200
1
37
5.4

Study Details

Study Description

Brief Summary

This experimental study is to verify a possible correlation between vascular disease, and anthropometric, and psychosocial measurements.

Consecutive patients with vascular diseases (Chronic Venous Disease, Carotid Stenosis, Abdominal Aortic Aneurysm, Peripheral Artery Disease) will be referred to Vascular Surgery Units of two hospitals linked to Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) to be evaluated.

Since it is necessary to study the anthropometric measures and the psychosocial aspects, different types of measurements will be carried out in order to correlate them with the aforementioned vascular disease.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: anthropometric and psychosocial measurements

Detailed Description

This is a cross sectional study with the aim analyze the association between the anthropometric and psychosocial measures in the following vascular disease: Chronic Venous Disease (CVD), Carotid Stenosis (CS) , Abdominal Aortic Aneurysm (AAA) , Peripheral Artery Disease (PAD).

Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) referred to Vascular Surgery Units of two hospitals (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) will be evaluated.

Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

The data will be extrapolated from a prospective analysis on patients, by inserting in a Microsoft Excel database: demographic characteristics (age, sex); anthropometric parameters (height, weight, BMI, waist circumference WHR WSR ABSI); comorbidities, with particular reference to Diabetes mellitus, Dyslipidemia, Hypertension, CRI, coronary heart disease; smoking as a risk factor; the questionnaire for psychosocial aspects (BIDQ) on cumulative score (1-15); the vascular disease under examination. Population variables (age) and continuous outcomes (weight, age, BMI, waist circumference, WHR, WSR, ABSI, BIDQ) will be analyzed by Kruskal-Wallis test, while categorical variables (males, smokers, hypertension, diabetes, insulin-dependent diabetes, dyslipidemia, CAD, renal insufficiency) with Pearson's Chi-square test. The statistically significant outcomes will be subjected to sub-analysis with t-test, to identify the comparisons responsible for statistical significance.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Association Between Anthropometric and Psychosocial Measurements in Vascular Disease
Actual Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Chronic Venous Disease Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements
Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

Carotid Stenosis Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements
Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

Abdominal Aortic Aneurysm Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements
Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

Peripheral Artery Disease Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements
Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

Outcome Measures

Primary Outcome Measures

  1. Analysis of BMI [32 months]

    This measurement (reported in kg/m^2) will be related to the presence of vascular disease

  2. Analysis of waist circumference [32 months]

    This measurement (reported in cm) will be related to the presence of vascular disease

  3. Analysis of waist / hip ratio (WHR) [32 months]

    This ratio will be related to the presence of vascular disease

  4. Analysis of waist / stature (WSR) [32 months]

    This ratio will be related to the presence of vascular disease

  5. Analysis of ABSI "a body" score shape index [32 months]

    This index (range: from "Less than -0.868" to "Greater than +0.798") will be related to the presence of vascular disease

  6. Administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ). [32 months]

    The BIDQ comprises seven items. Items 1-2 assess appearance concern and preoccupation, while item 3 measures perceived distress, and items 4-7 investigate functional impairment and avoidance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age >18 years, both genders, being a patient with one type of vascular disease at the time of the study.
Exclusion Criteria:
  • presence of more than one contemporary vascular disease at the time of the study, to avoid overlapping of concomitant vascular disease.

  • presence of any illiteracy, or psychiatric issues that may impair understanding or self-administration of the questionnaire.

  • malignancies.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Magna Graecia of Catanzaro Catanzaro Italy 88100

Sponsors and Collaborators

  • University of Catanzaro

Investigators

  • Study Chair: Raffaele Serra, M.D., Ph.D., University Magna Graecia of Catanzaro

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prof. Raffaele Serra, MD, Ph.D., Associate Professor of Vascular Surgery, University of Catanzaro
ClinicalTrials.gov Identifier:
NCT05472480
Other Study ID Numbers:
  • E.R.ALL.2018.51
First Posted:
Jul 25, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Raffaele Serra, MD, Ph.D., Associate Professor of Vascular Surgery, University of Catanzaro
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022