NCT05372237

Brief Summary

Cardiovascular diseases are the leading cause of death in the female population, and it disproportionately affects the young, who are often unaware of their risk profile, which includes both classic and relatively unknown elements. The rise in gestation disorders, depression, and eating disorders among young women must be taken into account. This means that greater awareness starting from the younger generations, and more specific research for women are needed to improve prevention and treatment strategies. "A Call for Women" is an observational study divided into multiple "calls." The first is a web-survey that will be launched in the Lombardy Region with the goal of raising awareness about women's cardiovascular health. Link for the web-survey \[Anticipated\]: https://it.surveymonkey.com/r/CallforWomen

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,969

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

May 9, 2022

Last Update Submit

November 30, 2023

Conditions

Keywords

cardiovascular diseasesgenderhealth awarenessweb-survey

Outcome Measures

Primary Outcomes (1)

  • To understand the awareness of CVD risk factors among women in Lombardy using a population-based web-survey

    With about 10 million people living in this region, Lombardy forms more than one-sixth of Italy's population, with a reasonable gender employment gap (15% - female employment rate 59.3% vs male employment rate 74.3% / ISTAT data September 2021)

    June 2022 (Anticipated) - April 2023 (Anticipated)

Secondary Outcomes (3)

  • To describe the characteristics of this large cohort of women while measuring their knowledge about health and lifestyle

    June 2022 (Anticipated) - April 2023 (Anticipated)

  • To describe the healthy/unhealthy behaviors of this large cohort of women

    June 2022 (Anticipated) - April 2023 (Anticipated)

  • To provide epidemiological information to researchers, clinicians and policy-makers about women's CVD

    June 2022 (Anticipated) - September 2023 (Anticipated)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population-based web-survey will be distributed among women (patients and healthcare providers) at IRCCS Policlinico San Donato but also in the general population via different social, economic and cultural environments also taking advantage of the collaboration of associations already active for women (Fondazione Onda, Soroptimist International, Doppia Difesa - nonprofit organization to protect women victims of violence, etc) or ATS (Health Protection Agency) - Città Metropolitana di Milano.

You may qualify if:

  • Being a woman
  • Being over the age of 18
  • Residing in the Lombardy region
  • Providing informed consent at the start of the population-based web-survey

You may not qualify if:

  • NOT Being a woman
  • NOT Being over the age of 18
  • NOT Residing in the Lombardy region
  • NOT Providing informed consent at the start of the population-based web-survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

Related Publications (10)

  • Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

    PMID: 30700139BACKGROUND
  • Vaccarino V, Parsons L, Peterson ED, Rogers WJ, Kiefe CI, Canto J. Sex differences in mortality after acute myocardial infarction: changes from 1994 to 2006. Arch Intern Med. 2009 Oct 26;169(19):1767-74. doi: 10.1001/archinternmed.2009.332.

    PMID: 19858434BACKGROUND
  • Mosca L, Hammond G, Mochari-Greenberger H, Towfighi A, Albert MA; American Heart Association Cardiovascular Disease and Stroke in Women and Special Populations Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, Council on Cardiovascular Nursing, Council on High Bloo. Fifteen-year trends in awareness of heart disease in women: results of a 2012 American Heart Association national survey. Circulation. 2013 Mar 19;127(11):1254-63, e1-29. doi: 10.1161/CIR.0b013e318287cf2f. Epub 2013 Feb 19.

    PMID: 23429926BACKGROUND
  • Cushman M, Shay CM, Howard VJ, Jimenez MC, Lewey J, McSweeney JC, Newby LK, Poudel R, Reynolds HR, Rexrode KM, Sims M, Mosca LJ; American Heart Association. Ten-Year Differences in Women's Awareness Related to Coronary Heart Disease: Results of the 2019 American Heart Association National Survey: A Special Report From the American Heart Association. Circulation. 2021 Feb 16;143(7):e239-e248. doi: 10.1161/CIR.0000000000000907. Epub 2020 Sep 21.

    PMID: 32954796BACKGROUND
  • Kouvari M, Souliotis K, Yannakoulia M, Panagiotakos DB. Cardiovascular Diseases in Women: Policies and Practices Around the Globe to Achieve Gender Equity in Cardiac Health. Risk Manag Healthc Policy. 2020 Oct 12;13:2079-2094. doi: 10.2147/RMHP.S264672. eCollection 2020.

    PMID: 33116988BACKGROUND
  • Mosca L, Ferris A, Fabunmi R, Robertson RM; American Heart Association. Tracking women's awareness of heart disease: an American Heart Association national study. Circulation. 2004 Feb 10;109(5):573-9. doi: 10.1161/01.CIR.0000115222.69428.C9. Epub 2004 Feb 4.

    PMID: 14761901BACKGROUND
  • Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

    PMID: 34458905BACKGROUND
  • Gnambs T, Kaspar K. Disclosure of sensitive behaviors across self-administered survey modes: a meta-analysis. Behav Res Methods. 2015 Dec;47(4):1237-1259. doi: 10.3758/s13428-014-0533-4.

    PMID: 25410404BACKGROUND
  • Eysenbach G, Wyatt J. Using the Internet for surveys and health research. J Med Internet Res. 2002 Apr-Nov;4(2):E13. doi: 10.2196/jmir.4.2.e13.

    PMID: 12554560BACKGROUND
  • Ball HL. Conducting Online Surveys. J Hum Lact. 2019 Aug;35(3):413-417. doi: 10.1177/0890334419848734. Epub 2019 May 14.

    PMID: 31084575BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Serenella Castelvecchio, MD

    IRCCS Policlinico S. Donato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 12, 2022

Study Start

September 29, 2022

Primary Completion

November 23, 2023

Study Completion

November 23, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

The results from this study will be property of the Promoter and will be used for dissemination through peer-reviewed publications and other forms of scientific communication such as abstracts, oral communications or posters.

Locations