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Not yet recruiting NCT07608393

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

— Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 test Administration 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

Primary outcome measures

  • Patients' Outcome [Time frame: At the baseline (the questionnaires will be administered only one time, since it's a cross-sectional study)]
Secondary outcome measures (10)
  • Cognitive status (6-item screener) [Time frame: At baseline]
  • Self-care of Chronic Illness Inventory [Time frame: Baseline]
  • Kansas City Cardiomyopathy Questionnaire [Time frame: Baseline]
  • Health Status Questionnaire - SF12 [Time frame: Baseline]
  • Patient Health Questionnaire PHQ9 [Time frame: Baseline]
  • Tilburg Fraility Index [Time frame: Baseline]
  • Caregiver contribution to self-care of heart failure index v.3 [Time frame: Baseline]
  • Caregiver contribution to self-care of chronic illness inventory [Time frame: Baseline]
  • Caregiver self-efficacy in contributing to self-care scale [Time frame: Baseline]
  • Caregiver preparedness scale [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07608393 · NP1159

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗