NCT06244953

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
18mo left

Started Aug 2024

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Aug 2024Oct 2027

First Submitted

Initial submission to the registry

January 17, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

August 14, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

January 17, 2024

Last Update Submit

April 6, 2025

Conditions

Heart Failure

Keywords

Palliative carePatientsCaregiversDistress thermometer (DT)Integrated Palliative Care Outcome Scale (IPOS)TIER-HF-PC

Outcome Measures

Primary Outcomes (1)

  • Patient quality of life (QOL)

    Patient quality of life will be measured at baseline, and again at 8 weeks, 16 weeks, and 24 weeks using KCCQ-12. Descriptive statistics, and measures of effect size will be used to compare the study groups at baseline, 8 weeks, 16 weeks, and 24 weeks. Longitudinal data analyses will be conducted to examine intervention effects using linear mixed-effects-modelling for repeated measures at baseline, 8 through 16 and 24 weeks, constraining the baseline mean to be equal between intervention and control groups with indicators for time, group, and time by group interactions. Estimate of standard deviation of residuals from the mixed-effects model will be used to compute effect size (Cohen's d) to estimate the efficacy. The minimum score on KCCQ is 0 and maximum possible score is 100. A higher score indicates a better quality of life.

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

Secondary Outcomes (7)

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

    Up to 48 weeks.

  • Patient anxiety and depression

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

  • Patient Spirituality

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

  • Caregiver Quality of Life

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

  • Assessment of impact of TIER-HF-PC on healthcare utilization

    Up to 24 weeks.

  • +2 more secondary outcomes

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-PCOTHER

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 CareOTHER

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

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients:
  • years or older and
  • able to communicate in English or Chinese 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 or Chinese.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 40147986DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular 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 63065838shirlyn.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

April 8, 2025

Record last verified: 2025-04

Locations

SG(4)