Heart FailureCOMFORT-HFNCT06892652
Comprehensive Management for Terminal Heart Failure Program:
A study testing Supportive care measures in people with Heart Failure, run by National Taiwan University Hospital.
Trial summary
Advanced heart failure presents with various symptoms, including pain, dyspnea, functional decline, reduced quality of life, and physiological deterioration, which can ultimately lead to spiritual distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Supportive care measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congestive heart failure at stage C or D
- Age ≥ 18 years
- Able to communicate in Chinese or Taiwanese
Who cannot join
- Pregnant women
- Patients who have previously received palliative care services
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Effects of Comprehensive Management for Terminal Heart Failure (COMFORT-HF) Program: A Pilot Randomized Controlled Trial
Advanced heart failure presents with various symptoms, including pain, dyspnea, functional decline, reduced quality of life, and physiological deterioration, which can ultimately lead to spiritual distress. The functional losses experienced by patients-encompassing physical, social, and mental aspects-place a significant burden on caregivers, impacting their physical, mental, and spiritual well-being. This burden is further intensified by the stress of making major medical decisions, highlighting the need for palliative care that extends beyond the patient. Addressing how to holistically support both patients and caregivers is a key focus of palliative care.
Studies have shown that integrating palliative care with heart failure treatment significantly improves patients' quality of life, as well as their comfort and dignity at the end of life. Evidence from multiple studies demonstrates the benefits of palliative care for heart failure patients, including enhanced quality of life, reduced emergency department visits and hospitalizations, and increased participation in advance care planning discussions. Consequently, national guidelines in several countries, including the United States and Europe, recommend the early integration of specialist palliative care for heart failure patients. However, the optimal timing for intervention by palliative care specialists remains undetermined.
Read more
This study aims to develop and assess the feasibility and effectiveness of the Comprehensive Management for Terminal Heart Failure (COMFORT-HF) program. Participants will be randomly assigned to either the experimental group, which will receive the COMFORT-HF model, or the control group, which will receive usual care. The implementation of the COMFORT-HF model involves heart failure case managers conducting screenings to identify patients for referral to a specialist palliative care team. Once the shared decision-making process is initiated and both the patient and the primary heart failure care team agree, palliative care specialists and shared care nurses will collaborate with the heart failure team to provide comprehensive, coordinated care, including regular visits.
The study aim to validate that the COMFORT-HF model produces positive outcomes for patients with advanced heart failure, making it a promising approach for broader implementation and promotion.
- Conditions
- Heart Failure
- Being tested
- Supportive care measures
- Keywords
- palliative care, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive care measuresOther
shared decision making with patients and families to receive specialist palliative care
| Study group | Role | What they receive |
|---|---|---|
| supportive care | Experimental | supportive care Receives: Other: Supportive care measures |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for measuring generic health-related quality of life. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Scoring Range: The EQ-5D-5L utility score ranges from -0.594 to 1, where 1 represents full health, 0 represents death, and negative values represent health states worse than death.
Interpretation: Higher scores indicate better health-related quality of life.
Measured: days 0, months 6, months 12
Secondary outcomes (3)
Kansas City Cardiomyopathy Questionnaire
The KCCQ is a disease-specific instrument designed to assess health status in heart failure patients. It includes multiple domains: physical limitation, symptom frequency, symptom burden, social limitation, and quality of life. The questionnaire generates an overall Total Summary Score (TSS).
Scoring Range:
Each domain score ranges from 0 to 100. The Total Summary Score (TSS) ranges from 0 to 100. Interpretation: Higher scores indicate better health status, fewer symptoms, and improved quality of life. A lower score represents worse symptoms and greater functional impairment.
Measured: Day 0, months 6, months 12
Quality of Dying Evaluation Form in the Hospice and Palliative Care Unit at National Taiwan University Hospital
This is a validated tool specifically designed to assess the quality of dying in terminally ill patients receiving hospice and palliative care. It evaluates multiple aspects, including symptom control, comfort, dignity, emotional support, and communication.
score ranging from 0 to 15 to summarize the extent to which the death was considered good. Interpretation: Higher scores indicate better quality of dying (e.g., better symptom relief, patient dignity, and family satisfaction), while lower scores suggest greater suffering or unmet needs.
Measured: During the intervention, If patient passed away
Spiritual well-being scale
The SWBS is a self-report questionnaire assessing two dimensions of spiritual well-being: Religious Well-Being (RWB) (connection to a higher power) and Existential Well-Being (EWB) (sense of life meaning and satisfaction). It consists of 20 items.
Scoring Range:
Each item is scored on a 6-point Likert scale (1 = strongly disagree, 6 = strongly agree).
The total score ranges from 20 to 120. The Religious Well-Being subscale ranges from 10 to 60, and the Existential Well-Being subscale also ranges from 10 to 60.
Interpretation: Higher scores indicate greater spiritual well-being, while lower scores suggest spiritual distress or dissatisfaction.
Measured: Day 0, months 6, months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892652
- Sponsor's protocol ID
- 202408115RINA
- Acronym
- COMFORT-HF
- Status last verified
- Nov 2024
- First submitted
- 10 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available under reasonable request to responsible authors
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Comprehensive Management for Terminal Heart Failure (COMFORT-HF) Program: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06892652
- Acronym / sponsor ID
- COMFORT-HF / 202408115RINA
- Conditions
- Heart Failure
- Keywords
- palliative care, heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Mar 2025 (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.
Advanced heart failure presents with various symptoms, including pain, dyspnea, functional decline, reduced quality of life, and physiological deterioration, which can ultimately lead to spiritual distress. The functional losses experienced by patients-encompassing physical, social, and mental aspects-place a significant burden on caregivers, impacting their physical, mental, and spiritual well-being. This burden is further intensified by the stress of making major medical decisions, highlighting the need for palliative care that extends beyond the patient. Addressing how to holistically support both patients and caregivers is a key focus of palliative care.
Studies have shown that integrating palliative care with heart failure treatment significantly improves patients' quality of life, as well as their comfort and dignity at the end of life. Evidence from multiple studies demonstrates the benefits of palliative care for heart failure patients, including enhanced quality of life, reduced emergency department visits and hospitalizations, and increased participation in advance care planning discussions. Consequently, national guidelines in several countries, including the United States and Europe, recommend the early integration of specialist palliative care for heart failure patients. However, the optimal timing for intervention by palliative care specialists remains undetermined.
This study aims to develop and assess the feasibility and effectiveness of the Comprehensive Management for Terminal Heart Failure (COMFORT-HF) program. Participants will be randomly assigned to either the experimental group, which will receive the COMFORT-HF model, or the control group, which will receive usual care. The implementation of the COMFORT-HF model involves heart failure case managers conducting screenings to identify patients for referral to a specialist palliative care team. Once the shared decision-making process is initiated and both the patient and the primary heart failure care team agree, palliative care specialists and shared care nurses will collaborate with the heart failure team to provide comprehensive, coordinated care, including regular visits.
The study aim to validate that the COMFORT-HF model produces positive outcomes for patients with advanced heart failure, making it a promising approach for broader implementation and promotion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supportive care | Experimental | Other: Supportive care measuressupportive care |
| Control | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Congestive heart failure at stage C or D
- Age ≥ 18 years
- Able to communicate in Chinese or Taiwanese
Key exclusion criteria (2 listed)
- Pregnant women
- Patients who have previously received palliative care services
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 |
|---|---|---|
| Supportive care measuresshared decision making with patients and families to receive specialist palliative care | Other | supportive care |
Primary outcome
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: days 0, months 6, months 12
The EQ-5D-5L is a standardized instrument for measuring generic health-related quality of life. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. Scoring Range: The EQ-5D-5L utility score ranges from -0.594 to 1, where 1 represents full health, 0 represents death, and negative values represent health states worse than death. Interpretation: Higher scores indicate better health-related quality of life.
3 secondary outcomes
Kansas City Cardiomyopathy Questionnaire
Time frame: Day 0, months 6, months 12
Quality of Dying Evaluation Form in the Hospice and Palliative Care Unit at National Taiwan University Hospital
Time frame: During the intervention, If patient passed away
Spiritual well-being scale
Time frame: Day 0, months 6, months 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Yes. The data was available under reasonable request to responsible authors
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care measures in people with Heart Failure, run by National Taiwan University Hospital.
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 3 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: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsien-Liang Huang (+886-2-23123456 ext. 266832, tennishuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol 5-Dimension 5-Level (EQ-5D-5L) (time frame: days 0, months 6, months 12). 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 27 Mar 2025.