NCT06146803

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

February 23, 2024

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 20, 2023

Last Update Submit

February 22, 2024

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Evaluate levels of resilience in subjects suffering from heart failure

    12 months

Secondary Outcomes (3)

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

    12 months

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

    12 months

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

    12 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCSS

Rome, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

NADIA ASPROMONTE, Prof.

CONTACT

0630154851nadia.aspromonte@policlinicogemelli.it

Study Design

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

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 27, 2023

Study Start

November 20, 2023

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

February 23, 2024

Record last verified: 2023-11

Locations

IT(1)