Palliative care interventions for heart failure patients and their caregivers

Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care

This study tests a new palliative care program for people with advanced heart failure and their caregivers to see if it can improve their quality of life and support their needs better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 21 Years to 99 Years
• Sex: All
• Sponsor: National Cancer Centre, Singapore (Academic / other)
• Locations: 4 sites (Singapore and 3 other locations)
• Trial ID: NCT06244953 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel palliative care model called TIER-HF-PC, designed to improve care delivery for patients with advanced heart failure and their caregivers. Led by a palliative care nurse and supported by a physician, the program actively screens patients for issues and tailors palliative care treatments based on their reported problems. The goal is to enhance patient quality of life, reduce healthcare utilization, and empower patients and caregivers through proactive support and education. The effectiveness of this model will be assessed over a 24-week period, focusing on various health outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with stage C or D heart failure who have experienced a related hospitalization within the last six months.

Not a fit: Patients with early-stage heart failure or those without a recent hospitalization may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for heart failure patients and their caregivers by providing timely and tailored palliative care.

How similar studies have performed: Previous studies have shown positive outcomes with similar palliative care interventions, indicating potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

* Patients:

  1. 21 years or older and
  2. able to communicate in English or Chinese and
  3. be of stage C or D heart failure, as defined by American College of Cardiology/American Heart Association (ACC/AHA) classification system and
  4. have functional limitation of New York Heart Association (NYHA) functional status of at least 2 or more and
  5. be deemed by their cardiologist's clinical judgement to have an expected prognosis of at least 6 months survival, and
  6. have had a heart failure related hospitalization event (e.g. symptomatic decompensated heart failure) within 6 months prior to recruitment and
  7. have a phone that allows telecommunication.
* Caregivers must meet all the following inclusion criteria to be eligible for the study :

  * direct, unpaid, family caregiver of the patient;
  * self-reported by the patient to be the main person to be either:
  * responsible for up to 4 hours a day of caregiving tasks
  * and/or decision maker/spokesperson with the medical team
  * Caregiver may or may not live in the same residence as the patient.
  * Caregivers must be 21 years and above.
  * Able to communicate in English or Chinese.

Exclusion Criteria:

* Patients:

  1. have cognitive impairment (e.g., dementia)
  2. have severe, untreated, active mental illness (e.g., major depressive disorder)
  3. have ventricular assist device implant.
  4. have non-reversible hearing or visual loss or
  5. are active drug abuser or
  6. already known to a palliative care service.
* Caregivers who meet any of the exclusion criteria at baseline will be ineligible for the study:

  * have cognitive impairment (e.g., dementia) or
  * have severe, untreated, active mental illness (e.g., major depressive disorder)
  * have non-reversible hearing or visual loss.
  * are active drug abuser or
  * are a domestic helper for the patient

Where this trial is running

Singapore and 3 other locations

• National Heart Centre Singapore — Singapore, Singapore (Recruiting)
• Sengkang General Hospital — Singapore, Singapore (Recruiting)
• Khoo Teck Puat Hospital — Singapore, Singapore (Recruiting)
• National Cancer Centre, Singapore — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS — National Cancer Centre, Singapore
• Study coordinator: Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS

Conditions Heart Failure; Palliative care; Patients; Caregivers; Distress thermometer; Integrated Palliative Care Outcome Scale; TIER-HF-PC