Heart FailureNCT07479160
Heart to Heart Web-based Communication Program for Heart Failure
A study testing Heart to Heart Web-based Communication Program in people with Heart Failure, run by Ajou University School of Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart to Heart Web-based Communication Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals unable to use the web-based platform
- Individuals who declined to participate or did not provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Heart to Heart Web-based Communication Program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart to Heart Web-based Communication ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Change in quality of life measured by the WHOQOL-BREF questionnaire
Measured: Baseline and 4 weeks after the intervention
Person-centered Care Competence
Change in person-centered care competence measured by the Individualized Care Scale
Measured: Baseline and 4 weeks after the intervention
Secondary outcomes (4)
Heart Failure Knowledge
Change in heart failure knowledge measured by the Dutch Heart Failure Knowledge Scale
Measured: Baseline and 4 weeks after the intervention
Self-care Behavior
Change in heart failure self-care behavior measured by the European Heart Failure Self-care Behavior Scale (EHFScB-9)
Measured: Baseline and 4 weeks after the intervention
Caregiver Burden
Change in caregiver burden measured by the Burden Scale for Family Caregivers (BSFC-s)
Measured: Baseline and 4 weeks after the intervention
Patient-centered Communication Competence
Change in patient-centered communication competence measured by the Slatore communication scale
Measured: Baseline and 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Ah Ahn, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479160
- Sponsor's protocol ID
- M-2024-A0403-00011
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-based Family-Centered Communication Program on Heart Failure Trajectory and Palliative Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07479160
- Acronym / sponsor ID
- M-2024-A0403-00011
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Mar 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 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart to Heart Program | Experimental | Behavioral: Heart to Heart Web-based Communication ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals unable to use the web-based platform
- Individuals who declined to participate or did not provide informed consent
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 |
|---|---|---|
| Heart to Heart Web-based Communication ProgramA 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. | Behavioural | Heart to Heart Program |
Primary outcome
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
4 secondary outcomes
Heart Failure Knowledge
Time frame: Baseline and 4 weeks after the intervention
Self-care Behavior
Time frame: Baseline and 4 weeks after the intervention
Caregiver Burden
Time frame: Baseline and 4 weeks after the intervention
Patient-centered Communication Competence
Time frame: Baseline and 4 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart to Heart Web-based Communication Program in people with Heart Failure, run by Ajou University School of Medicine at 1 site in South Korea.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in quality of life (time frame: Baseline and 4 weeks after the intervention). The study lists 2 primary outcomes in all. 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 18 Mar 2026.