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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06146803
Other study ID # 6079
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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