NCT07608393

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2027

Study Start

First participant enrolled

May 1, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 27, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

May 13, 2026

Last Update Submit

May 19, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Patients' Outcome

    Self-care in heart failure (SCHFI V.8)

    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)

    At baseline

  • Self-care of Chronic Illness Inventory

    Baseline

  • Kansas City Cardiomyopathy Questionnaire

    Baseline

  • Health Status Questionnaire - SF12

    Baseline

  • Patient Health Questionnaire PHQ9

    Baseline

  • +5 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

500 patients with heart failure and 500 caregivers of patients with heart failure

You may qualify if:

  • 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

You may not qualify if:

  • cognitive impairment
  • surgery or heart attack in the last 3 months
  • having a LVAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 27, 2026

Record last verified: 2025-12