Comprehensive Management for Terminal Heart Failure Program: (COMFORT-HF)

March 24, 2025 updated by: National Taiwan University Hospital

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
usual care
Experimental: supportive care
Other: Supportive care measures
shared decision making with patients and families to receive specialist palliative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
days 0, months 6, months 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kansas City Cardiomyopathy Questionnaire
Time Frame: Day 0, months 6, months 12

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.
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

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.
During the intervention, If patient passed away
Spiritual well-being scale
Time Frame: Day 0, months 6, months 12

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.
Day 0, months 6, months 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202408115RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data was available under reasonable request to responsible authors

IPD Sharing Time Frame

IPD will be available after acceptance of the submission to journal

IPD Sharing Access Criteria

reasonable request to corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Supportive care measures

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe