Psychological Status and Self-care in Chronic Cardiovascular Disease

• Sponsor: Centro Cardiologico Monzino (Other)
• Overall Status: Completed
• CT.gov ID: NCT05750420
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 72.5

Study Details

Study Description

Brief Summary

This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Depression; Emotional Stress; Quality of Life; Self-care; Chronic Cardiovascular Disease	Other: There was no intervention, the study was a cross-sectional observational study

Detailed Description

400 patients with chronic cardiovascular disease were enrolled in this observational study aiming at exploring the relationship between their psychological status (anxiety, depression, emotional distress and quality of life) and their self-care.

Study Design

• Study Type: Observational
• Actual Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Psychological Status and Self-care: a Preliminary Study Involving Patients With Chronic Cardiovascular Disease
• Actual Study Start Date: Jul 28, 2022
• Actual Primary Completion Date: Jan 12, 2023
• Actual Study Completion Date: Jan 12, 2023

Outcome Measures

Primary Outcome Measures

1. Psychological status and self-care [At the moment of enrollment]

   Investigating the relationship between psychological status and self-care in patients with chronic cardiovascular disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Being aged > 18 years old and > 85 years old

• Being diagnosed with a chronic cardiovascular disease

• Being able and willing to sign the Informed Consent Form

Exclusion Criteria:

• Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation

• Not speaking Italian

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monzino Cardiology Center	Milan		Italy	20138

Sponsors and Collaborators

• Centro Cardiologico Monzino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centro Cardiologico Monzino
• ClinicalTrials.gov Identifier: NCT05750420
• Other Study ID Numbers: CCM1789
• First Posted: Mar 1, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• 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
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Mar 1, 2023