Comprehensive Management for Terminal Heart Failure Program:

NCT ID: NCT06892652

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

supportive care

supportive care

Group Type: EXPERIMENTAL

Supportive care measures

Intervention Type: OTHER

shared decision making with patients and families to receive specialist palliative care

Control

usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supportive care measures

shared decision making with patients and families to receive specialist palliative care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hsien-Liang Huang

Role: CONTACT

tennishuang@gmail.com

+886-2-23123456 ext. 266832

Other Identifiers

202408115RINA

Identifier Type: -

Identifier Source: org_study_id