Clinical trial NCT06892652: Comprehensive Management for Terminal Heart Failure Program:
Official title: Feasibility and Effects of Comprehensive Management for Terminal Heart Failure (COMFORT-HF) Program: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: palliative care
heart failure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Congestive heart failure at stage C or D
2. Age ≥ 18 years
3. Able to communicate in Chinese or Taiwanese

Exclusion Criteria:

1. Pregnant women
2. Patients who have previously received palliative care services

Primary outcomes:
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: days 0, months 6, months 12
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: Day 0, months 6, months 12
measure: Quality of Dying Evaluation Form in the Hospice and Palliative Care Unit at National Taiwan University Hospital
timeFrame: During the intervention, If patient passed away
measure: Spiritual well-being scale
timeFrame: Day 0, months 6, months 12
Other outcomes:
Locations:
Study officials:
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