Heart to Heart Web-based Communication Program for Heart Failure

March 13, 2026 updated by: Jeong-Ah Ahn, Ajou University School of Medicine

Effectiveness of a Web-based Family-Centered Communication Program on Heart Failure Trajectory and Palliative Care: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Suwon, South Korea, 16499
        • Ajou University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart to Heart Program
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
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.
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: Baseline and 4 weeks after the intervention
Change in quality of life measured by the WHOQOL-BREF questionnaire
Baseline and 4 weeks after the intervention
Person-centered Care Competence
Time Frame: Baseline and 4 weeks after the intervention
Change in person-centered care competence measured by the Individualized Care Scale
Baseline and 4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Knowledge
Time Frame: Baseline and 4 weeks after the intervention
Change in heart failure knowledge measured by the Dutch Heart Failure Knowledge Scale
Baseline and 4 weeks after the intervention
Self-care Behavior
Time Frame: Baseline and 4 weeks after the intervention
Change in heart failure self-care behavior measured by the European Heart Failure Self-care Behavior Scale (EHFScB-9)
Baseline and 4 weeks after the intervention
Caregiver Burden
Time Frame: Baseline and 4 weeks after the intervention
Change in caregiver burden measured by the Burden Scale for Family Caregivers (BSFC-s)
Baseline and 4 weeks after the intervention
Patient-centered Communication Competence
Time Frame: Baseline and 4 weeks after the intervention
Change in patient-centered communication competence measured by the Slatore communication scale
Baseline and 4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2024-A0403-00011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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