Comprehensive Management for Terminal Heart Failure Program:

NCT06892652 | Not Yet Recruiting

• 1 other identifier: 202408115RINA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

palliative care; heart failure

Outcome Measures

Primary Outcomes (1)

• 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.

  days 0, months 6, months 12

Secondary Outcomes (3)

• Kansas City Cardiomyopathy Questionnaire

  Day 0, months 6, months 12

• Quality of Dying Evaluation Form in the Hospice and Palliative Care Unit at National Taiwan University Hospital

  During the intervention, If patient passed away

• Spiritual well-being scale

  Day 0, months 6, months 12

Study Arms (2)

supportive care

EXPERIMENTAL

supportive care

Other: Supportive care measures

Control

NO INTERVENTION

usual care

Interventions

Supportive care measures OTHER

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

supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Congestive heart failure at stage C or D
• Age ≥ 18 years
• Able to communicate in Chinese or Taiwanese

You may not qualify if:

• Pregnant women
• Patients who have previously received palliative care services

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Hsien-Liang Huang

CONTACT

+886-2-23123456; tennishuang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available after acceptance of the submission to journal
• Access Criteria: reasonable request to corresponding author