Validation of the Italian SCHFI v.8 and the CC-SCHFI v.3

May 19, 2026 updated by: Centro Cardiologico Monzino

Validation of the Italian Version of the Self-care of Heart Failure Index (SCHFI) v.8 and the Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) v.3

This observational study aims at validating the Italian Self-care of Heart Failure Index (SCHFI) v.8 and the Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) v.3

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

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

N/A

Sampling Method

Probability Sample

Study Population

500 patients with heart failure and 500 caregivers of patients with heart failure

Description

Inclusion Criteria for patients:

  • Ability to understand and speak Italian
  • Willingness to firm the informed consent form
  • Heart Failure for at least 3 months
  • Aged >/= 18 years old

Inclusion Criteria for caregivers:

  • Ability to speak and understand Italian
  • Being selected as principal caregiver by the patient
  • Aged >/= 18 years old

Exclusion Criteria:

  • cognitive impairment
  • surgery or heart attack in the last 3 months
  • having a LVAD

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
Measure Description
Time Frame
Patients' Outcome
Time Frame: At the baseline (the questionnaires will be administered only one time, since it's a cross-sectional study)
Self-care in heart failure (SCHFI V.8)
At the baseline (the questionnaires will be administered only one time, since it's a cross-sectional study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive status (6-item screener)
Time Frame: At baseline
6-item questionnaire for evaluating cognitive status
At baseline
Self-care of Chronic Illness Inventory
Time Frame: Baseline
Self-reported questionnaire for evaluating self-care
Baseline
Kansas City Cardiomyopathy Questionnaire
Time Frame: Baseline
Self-reported questionnaire for evaluating quality of life
Baseline
Health Status Questionnaire - SF12
Time Frame: Baseline
Self-reported questionnaire for evaluating health status
Baseline
Patient Health Questionnaire PHQ9
Time Frame: Baseline
Self-reported questionnaire for evaluating depression
Baseline
Tilburg Fraility Index
Time Frame: Baseline
Self-reported questionnaire for evaluating fraility
Baseline
Caregiver contribution to self-care of heart failure index v.3
Time Frame: Baseline
Self-reported questionnaire
Baseline
Caregiver contribution to self-care of chronic illness inventory
Time Frame: Baseline
Self-reported
Baseline
Caregiver self-efficacy in contributing to self-care scale
Time Frame: Baseline
Baseline
Caregiver preparedness scale
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Centro Cardiologico Monzino

Collaborators

Federico II University
IRCCS Policlinico S. Donato
University of Rome Tor Vergata
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
IRCCS Multimedica
A.O. Ospedale Papa Giovanni XXIII
Azienda Ospedaliera Universitaria Renato Dulbecco
IRCCS Centro Neurolesi Bonino Pulejo

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP1159

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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