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

February 22, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Recruiting

Conditions

Detailed 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

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate levels of resilience in subjects suffering from heart failure
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate levels of self-care in subjects suffering from heart failure
Time Frame: 12 months
12 months
Evaluate the correlation between the level of resilience and the level of self-care
Time Frame: 12 months
12 months
Evaluate which characteristics positively influence the level of resilience and the degree of self-care of patients with heart failure
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

November 20, 2024

Study Completion (Estimated)

November 20, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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