TIER-HF-PC: 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).
Usual Care: 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.
Study 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.
Eligibility
Sex
ALL
Min age
21 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients:
1. 21 years or older and
2. able to communicate in English/Chinese/Malay 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/Chinese/Malay.
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
Primary outcome measure(s)
Patient quality of life (QOL) per the KCCQ-12 Questionnaire — Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. 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.
Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire — Baseline, 8 weeks, 16 weeks, and 24 weeks. 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.
Caregiver Quality of Life (QOL) — Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. 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.
Trial sites (4)
Facility
City
Region
Status
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
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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