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Clinical Trials/NCT07479160
NCT07479160CompletedNot Applicable

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

Ajou University School of Medicine1 site in 1 country150 target enrollmentStarted: June 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Change in quality of life

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Heart to Heart Web-based Communication Program (Behavioral)

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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeong-Ah Ahn

Professor

Ajou University School of Medicine

Study Sites (1)

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