NCT06892652

Comprehensive Management for Terminal Heart Failure Program:

Feasibility and Effects of Comprehensive Management for Terminal Heart Failure (COMFORT-HF) Program: A Pilot Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Supportive care measures	shared decision making with patients and families to receive specialist palliative care

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2025-03-25
• Last updated: 2025-03-27