NCT07479160

Brief Summary

This randomized controlled trial evaluates the effectiveness of a web-based family-centered communication enhancement program ("Heart to Heart") designed for patients with heart failure, family caregivers, and cardiac nurses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 10, 2026

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in quality of life

    Change in quality of life measured by the WHOQOL-BREF questionnaire

    Baseline and 4 weeks after the intervention

  • Person-centered Care Competence

    Change in person-centered care competence measured by the Individualized Care Scale

    Baseline and 4 weeks after the intervention

Secondary Outcomes (4)

  • Heart Failure Knowledge

    Baseline and 4 weeks after the intervention

  • Self-care Behavior

    Baseline and 4 weeks after the intervention

  • Caregiver Burden

    Baseline and 4 weeks after the intervention

  • Patient-centered Communication Competence

    Baseline and 4 weeks after the intervention

Study Arms (2)

Heart to Heart Program

EXPERIMENTAL

Participants receive the "Heart to Heart" web-based communication enhancement program for four weeks. The program includes educational video modules and printable resources designed to improve understanding of heart failure trajectory, goals-of-care conversations, and palliative care communication among patients with heart failure, their family caregivers, and cardiac nurses.

Behavioral: Heart to Heart Web-based Communication Program

Usual Care

NO INTERVENTION

Participants receive routine cardiology follow-up and standard education regarding heart failure self-care without access to the web-based communication program during the study period.

Interventions

A 4-week web-based communication enhancement program consisting of educational video modules and printable resources addressing heart failure trajectory, goals-of-care conversations, and palliative care communication for patients with heart failure, family caregivers, and cardiac nurses.

Heart to Heart Program

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 19 years or older with a confirmed diagnosis of heart failure for at least one year
  • Receiving outpatient follow-up care in the cardiology clinic
  • Accompanied by a primary family caregiver
  • Able to access and use a web-based platform
  • Family caregivers who are primarily involved in the patient's care and able to use a web-based platform
  • Cardiac nurses with at least three years of clinical experience in the cardiovascular department

You may not qualify if:

  • Individuals unable to use the web-based platform
  • Individuals who declined to participate or did not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Medical Center

Suwon, 16499, South Korea

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 18, 2026

Study Start

June 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations