the "Level of Resilience" Influencing Self-care in Heart Failure Patients

Congestive Heart Failure Clinical Trial

Official title:

How Much the "Level of Resilience" Influences Self-care in a Group of Subjects Suffering From Heart Failure: Observational, Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146803
• Other study ID #: 6079
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: November 20, 2024

Study information

• Verified date: November 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: NADIA ASPROMONTE, Prof.
• Phone: 0630154851
• Email: nadia.aspromonte[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones

Description:

Primary objective

-Evaluate levels of resilience in subjects suffering from heart failure.

Secondary objectives

• Evaluate the levels of self-care in subjects suffering from heart failure.

• Evaluate the correlation between the level of resilience and the level of self-care;

• Evaluate which characteristics positively influence the level of resilience and the degree of self-care of the person with heart failure.

Consecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 20, 2024
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects suffering from heart failure;

• Subject aged between >18 years and <90 years;

• Ability to understand the Italian language;

• Clinical conditions that allow the questionnaire to be completed;

• Ability to provide written informed consent.

Exclusion Criteria:

• Subjects suffering from other forms of diabetes;

• Subjects suffering from serious psychiatric disorders;

• Serious clinical conditions that do not allow the questionnaire to be completed;

• Inability to provide written informed consent.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCSS	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate levels of resilience in subjects suffering from heart failure		12 months
Secondary	Evaluate levels of self-care in subjects suffering from heart failure		12 months
Secondary	Evaluate the correlation between the level of resilience and the level of self-care		12 months
Secondary	Evaluate which characteristics positively influence the level of resilience and the degree of self-care of patients with heart failure		12 months