Heart FailureNCT07608393
Validation of the Italian SCHFI v.8 and the CC-SCHFI v.3
An observational study of Heart Failure, run by Centro Cardiologico Monzino.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2027
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 500 patients with heart failure and 500 caregivers of patients with heart failure
Who may be able to join
- Ability to understand and speak Italian
- Willingness to firm the informed consent form
- Heart Failure for at least 3 months
- Aged >/= 18 years old
- Ability to speak and understand Italian
- Being selected as principal caregiver by the patient
- Aged >/= 18 years old
Who cannot join
- cognitive impairment
- surgery or heart attack in the last 3 months
- having a LVAD
About this study
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
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
- Conditions
- Heart Failure
- Being tested
- Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measuresDiagnostic test
Participants will be asked to answer some questionnaires among which the SCHFI v.8 and the CC-SCHFI v.3
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Outcome
Self-care in heart failure (SCHFI V.8)
Measured: At the baseline (the questionnaires will be administered only one time, since it's a cross-sectional study)
Secondary outcomes (10)
Cognitive status (6-item screener)
6-item questionnaire for evaluating cognitive status
Measured: At baseline
Self-care of Chronic Illness Inventory
Self-reported questionnaire for evaluating self-care
Measured: Baseline
Kansas City Cardiomyopathy Questionnaire
Self-reported questionnaire for evaluating quality of life
Measured: Baseline
Health Status Questionnaire - SF12
Self-reported questionnaire for evaluating health status
Measured: Baseline
Patient Health Questionnaire PHQ9
Self-reported questionnaire for evaluating depression
Measured: Baseline
Tilburg Fraility Index
Self-reported questionnaire for evaluating fraility
Measured: Baseline
Caregiver contribution to self-care of heart failure index v.3
Self-reported questionnaire
Measured: Baseline
Caregiver contribution to self-care of chronic illness inventory
Self-reported
Measured: Baseline
Caregiver self-efficacy in contributing to self-care scale
Measured: Baseline
Caregiver preparedness scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608393
- Sponsor's protocol ID
- NP1159
- Status last verified
- Dec 2025
- First submitted
- 13 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07608393
- Acronym / sponsor ID
- NP1159
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or 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
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 500 patients with heart failure and 500 caregivers of patients with heart failure
Key inclusion criteria (7 listed)
- Ability to understand and speak Italian
- Willingness to firm the informed consent form
- Heart Failure for at least 3 months
- Aged >/= 18 years old
- Ability to speak and understand Italian
Key exclusion criteria (3 listed)
- cognitive impairment
- surgery or heart attack in the last 3 months
- having a LVAD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measuresParticipants will be asked to answer some questionnaires among which the SCHFI v.8 and the CC-SCHFI v.3 | Diagnostic test | – |
Primary outcome
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)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Centro Cardiologico Monzino.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Outcome (time frame: At the baseline (the questionnaires will be administered only one time, since it's a cross-sectional study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.