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

NCT06244953 | Recruiting DMC

• 1 other identifier: TIER-HF-PC
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

There is evidence for the effectiveness and feasibility of the individual components of TIER-HF-PC, however there is a need to test how these individual components interact to allow the researchers to deliver TIER-HF-PC as a model of care in its totality. In the short term, this study will assess if TIER-HF-PC is beneficial for patients and caregivers.

Conditions

Heart Failure

Keywords

Palliative care; Patients; Caregivers; Distress thermometer (DT); Integrated Palliative Care Outcome Scale (IPOS); TIER-HF-PC

Outcome Measures

Primary Outcomes (3)

• Patient quality of life (QOL) per the KCCQ-12 Questionnaire

  The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used: It is a 12-item QOL scale, composed of physical function, symptoms, QOL, social interference and summary score will be used. The KCCQ-12 has similar validity to the 23-item version and is shorter with less respondent burden. The KCCQ-12 can be self-reported by patients or read to patients over the phone by a research coordinator. The total summary score can range from 0 to 100, with higher scores representing better health status. A clinically meaningful change is defined as a change of at least 5 points on the KCCQ. The KCCQ-12 will be measured for all participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. The frequency of our proposed KCCQ tracking is referenced from trials which used KCCQ to track longitudinal changes in QOL.

  Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.

• Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire

  The non cardiac specific health-related quality of life (EUROQOL EQ-5D-5L) questionnaire will also be used: This is a global assessment of the patient's quality-of-life in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, that can also be administered over the phone. The results from the 5 dimensions can be combined into a 5-digit number that describes the patient's health state utility. The EQ-5D-5L has been validated in the Singapore cardiac population.

  Baseline, 8 weeks, 16 weeks, and 24 weeks.

• Caregiver Quality of Life (QOL)

  The Singapore Caregiver Quality of Life Scale-15 (SCQOLS-15) will be used: This is a 15-item scale with 5 domains measuring QOL of life caregivers in domains: physical well-being, mental well-being, experience and meaning, impact on daily life, and financial well-being will be used. This will be measured for all caregiver participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. A difference of between 3-5 points in QOL scores could serve as a benchmark to evaluate if the difference between intervention and usual-care group is meaningful.

  Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.

Secondary Outcomes (8)

• Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)

  At Week 25.

• Acceptability of TIER-HF-PC from patient and caregiver participants - through semi-structured interviews

  From Week 25 onwards, up to Week 48.

• Patient anxiety and depression

  Baseline, 8 weeks, 16 weeks, and 24 weeks.

• Patient and Caregiver Spirituality

  Baseline, 8 weeks, 16 weeks, and 24 weeks.

• Patient and Caregiver Coping

  Baseline, 8 weeks, 16 weeks, and 24 weeks.

Study Arms (2)

Regular screening with needs-guided palliative care treatments

EXPERIMENTAL

The patient continues to receive clinical care from the cardiologist, as well as palliative care treatments that are based upon his/her reported distress and concerns.

Other: TIER-HF-PC

Usual Care

OTHER

Patient is referred by cardiologist to palliative care.

Other: Usual Care

Interventions

TIER-HF-PC OTHER

The patient will be assigned to one of the three levels of care which is determined by the results given by Distress Thermometer (DT) and the Integrated Palliative Care Outcome Scale (IPOS).

Regular screening with needs-guided palliative care treatments

Usual Care OTHER

Patient continues on clinical care by his/her cardiologist. If the cardiologist picks up their symptoms or other concerns, he/or can be referred to a specialist palliative care physician by the cardiologist.

Usual Care

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• years or older and
• able to communicate in English/Chinese/Malay and
• be of stage C or D heart failure, as defined by American College of Cardiology/American Heart Association (ACC/AHA) classification system and
• have functional limitation of New York Heart Association (NYHA) functional status of at least 2 or more and
• be deemed by their cardiologist's clinical judgement to have an expected prognosis of at least 6 months survival, and
• have had a heart failure related hospitalization event (e.g. symptomatic decompensated heart failure) within 6 months prior to recruitment and
• have a phone that allows telecommunication.
• 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/Chinese/Malay.

You may not qualify if:

• Patients:
• have cognitive impairment (e.g., dementia)
• have severe, untreated, active mental illness (e.g., major depressive disorder)
• have ventricular assist device implant.
• have non-reversible hearing or visual loss or
• are active drug abuser or
• already known to a palliative care service.
• 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

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• National Heart Centre Singapore: collaborator
• Khoo Teck Puat Hospital: collaborator
• Sengkang General Hospital: collaborator

Study Sites (4)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

RECRUITING

National Cancer Centre, Singapore

Singapore, Singapore

RECRUITING

Related Publications (1)

• Neo SH, Yu K, Lee CF, Cheung YB. Interventions to enable and reach patients with heart failure and their caregivers, with palliative care (TIER-HF-PC): a study protocol of a two-armed parallel group, open label randomised controlled trial that evaluates the effectiveness of a tiered model of palliative care in tertiary cardiac institutes in Singapore. BMJ Open. 2025 Mar 27;15(3):e100581. doi: 10.1136/bmjopen-2025-100581.

  PMID: 40147986 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS

CONTACT

+65 63065838; shirlyn.neo.h.s@singhealth.com.sg

Study Design

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

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 6, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

SG (4)