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

NCT07608393 — Not yet recruiting, 1000 participants, Centro Cardiologico Monzino

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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

Registry	NCT07608393
Status	Not yet recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	Centro Cardiologico Monzino (Other); collaborators: University of Rome Tor Vergata, IRCCS Policlinico S. Donato, A.O. Ospedale Papa Giovanni XXIII, IRCCS Multimedica, Federico II University, Azienda Ospedaliera Universitaria Renato Dulbecco, Azienda Ospedaliera Universitaria Policlinico "G. Martino", IRCCS Centro Neurolesi Bonino Pulejo
Conditions	Heart Failure
Interventions	Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures (Diagnostic test)
Dates	start 2026-05-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-05-27, last updated 2026-05-27

-Summary

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

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+Arms and interventions

Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures (Diagnostic test): Participants will be asked to answer some questionnaires among which the SCHFI v.8 and the CC-SCHFI v.3

+Outcome measures

Primary outcomes

Patients' Outcome [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)

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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