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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07608393

Enrollment

1000

Registered

2026-05-27

Start date

2026-05-01

Completion date

2027-05-01

Last updated

2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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

Interventions

DIAGNOSTIC_TESTAdministration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures

Participants will be asked to answer some questionnaires among which the SCHFI v.8 and the CC-SCHFI v.3

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026