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.
21 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
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
Parallel
TIER-HF-PC
Other interventionThe 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
Other interventionPatient 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.
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.
Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)
The total score of the CSQ-4 will be calculated for each participant. For the assessment of acceptability, scores from participants from both intervention and control groups will be pooled. The minimum expected score per participant is 4, and the maximum expected score per participant is 16. A higher score indicates higher satisfaction. The percentage of participants in TIER-HF-PC who have at least a CSQ score of 12 and above will also be calculated.
Patient anxiety and depression
Patient anxiety will be tracked at baseline, 8 weeks, 16 weeks, and 24 weeks, using the hospital anxiety and depression scale (HADS). 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.
Patient Spirituality
Patient spirituality will be tracked at baseline, 8 weeks, 16 weeks and 24 weeks, using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp-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.
Caregiver Quality of Life
The change in caregiver quality of life (QOL) at 8 weeks, 16 weeks, and 24 weeks as compared to baseline will be evaluated. The outcome measure used is the Singapore Caregiver Quality of Life Scale (SCQOLS-15). 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.
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National Cancer Centre, Singapore
Lead sponsor
National Heart Centre Singapore
Collaborator
Khoo Teck Puat Hospital
Collaborator
