NCT05750420

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

February 20, 2023

Last Update Submit

April 12, 2023

Conditions

AnxietyDepressionEmotional StressQuality of LifeSelf-careChronic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Psychological status and self-care

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

    At the moment of enrollment

Interventions

There was no intervention, the study was a cross-sectional observational studyOTHER

Questionnaires for measuring self-care, anxiety, depression, emotinal distress and quality of live were administered to patients with chronic cardiovascular disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with chronic cardiovascular disease

You may qualify if:

  • 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

You may not qualify if:

  • Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation
  • Not speaking Italian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monzino Cardiology Center

Milan, 20138, Italy

Location

IRCCS San Gerardo

Monza, 20900, Italy

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStress, Psychological

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 1, 2023

Study Start

July 28, 2022

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)