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NCT Number: NCT07608393

Validation of the Italian SCHFI v.8 and the 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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Cognitive status (6-item screener)

    Time frame: At baseline

    6-item questionnaire for evaluating cognitive status

  2. Self-care of Chronic Illness Inventory

    Time frame: Baseline

    Self-reported questionnaire for evaluating self-care

  3. Kansas City Cardiomyopathy Questionnaire

    Time frame: Baseline

    Self-reported questionnaire for evaluating quality of life

  4. Health Status Questionnaire - SF12

    Time frame: Baseline

    Self-reported questionnaire for evaluating health status

  5. Patient Health Questionnaire PHQ9

    Time frame: Baseline

    Self-reported questionnaire for evaluating depression

  6. Tilburg Fraility Index

    Time frame: Baseline

    Self-reported questionnaire for evaluating fraility

  7. Caregiver contribution to self-care of heart failure index v.3

    Time frame: Baseline

    Self-reported questionnaire

  8. Caregiver contribution to self-care of chronic illness inventory

    Time frame: Baseline

    Self-reported

  9. Caregiver self-efficacy in contributing to self-care scale

    Time frame: Baseline

  10. Caregiver preparedness scale

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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