Abstract
Objectives
To evaluate the feasibility, acceptability and potential efficacy of the culturally adapted Educate, Nurture, Advise Before Life Ends (ENABLE) programme in Singapore for patients with heart failure (HF) and their family caregivers.
Design
Non-blinded randomised wait-list controlled pilot study, using Simon’s randomised phase II trial design.
Setting
Specialist outpatient clinics in a tertiary cardiac centre in Singapore.
Participants
Patients had a diagnosis of American Heart Association Stage C or D HF, were symptomatic with New York Heart Association functional class 2 and above symptoms, had a prognosis of 6 months, a hospitalisation in prior 6 months and were on disease-directed HF management. Patients already known to palliative care (PC) were excluded. Recruited caregivers were family caregivers of patients.
Intervention
ENABLE integrates PC early into HF care. It starts with a comprehensive PC assessment with a PC physician and nurse. This is followed by a series of nurse coach-led health coaching sessions for both patients and caregivers. After the completion of health coaching, participants would receive follow-up phone calls to review their coping up to 6 months post-enrolment.
Outcome measures
Feasibility was defined by the proportion of approached patient-caregiver dyads who consented to participate and the proportion of participants who completed health coaching. Acceptability was defined by a score of at least 12 out of a maximum of 16 for the Client Satisfaction Questionnaire 4-Item Survey. Primary efficacy outcome measure was the change in patient quality of life (QOL) at 6 months as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) total score, with the target effect size (Cohen’s d) being at least 0.25 SD in favour of ENABLE. Other secondary outcomes included patient/caregiver anxiety and depression scores on the Hospital Anxiety and Depression Scale, spirituality scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale and caregiver QOL on the Singapore Caregiver Quality of Life Scale.
Results
Feasibility: recruitment was carried out from February 2022 to October 2023. We approached 164 patient-caregiver dyads and 60 patient-caregiver dyads (36.6%) consented. A total of 48 patients and 44 caregivers started on health coaching, of which 44 patients (91.7%) and 43 caregivers (97.7%) completed health coaching.
Acceptability: patients’ satisfaction was high, at 85.7% and 87.5% in the intervention and wait-list arm, respectively. Caregivers were similarly satisfied, at 100% and 87.5% in the two arms, respectively.
Efficacy: intervention-arm patients had a higher mean total KCCQ score at 6 months than wait-list-arm patients (difference in means=12.4; 95% CI 0.9 to 24.0; Cohen’s d=0.43). There was no difference in caregiver QOL changes between trial arms at 3 months and 6 months. Both patients and caregivers had improvements in anxiety at 3 months and sustained improvements in depression and spirituality at 6 months.
Conclusions
Proportion of participants who completed health coaching was high, though proportion of approached participants who consented was lower than expected. Our acceptability and efficacy targets were met. Further phase III testing is planned.
Trial registration number
Keywords: PALLIATIVE CARE, Heart failure, Patients, Caregivers
Background
In Singapore, a city-state in South-East Asia, cardiac-related deaths accounted for 25.2% of all deaths in 2023.1 Asian heart failure (HF) patients typically present at a younger age, with more severe clinical features and longer hospital stays than non-Asians.2 Patients with HF usually experience marked symptom burden, especially towards the end of life, and there is often an equal, if not greater toll on their caregivers. Palliative care improves symptom burden, quality of life (QOL) and potentially, survival in patients with serious illnesses particularly when provided earlier in the patient’s illness journey.3,7 Early access to palliative care can also improve satisfaction of caregivers with care provision and allow them to feel more confident in their caregiving roles.8 9 Additionally, palliative care professionals can help facilitate communication between patients, caregivers and their healthcare team.10
The ‘Educate, Nurture, Advise, Before Life Ends’ (ENABLE) programme is a manualised, nurse-led palliative care coaching programme (based on Wagner’s chronic illness care model)11 that aims to empower patients and caregivers to manage their problems and prepare for the future, early in the illness trajectory. It was first developed for the cancer setting in the USA and was shown to have a beneficial impact on patients and caregivers.5 6 12 13 Because of its effectiveness, it was adapted in the USA for HF patients and caregivers and the pilot study showed that it was feasible and acceptable to HF patients and caregivers.14 A large-scale randomised controlled trial showed that there was improvement in HF patients’ pain control, which is significant as pain is a commonly under-detected symptom in HF.15 16 In addition, patients who had a poorer QOL at baseline had greater QOL improvement than those who did not.15
As described by the Medical Research Council (UK) guidance for complex intervention research, the feasibility, acceptability and effectiveness of a complex intervention such as ENABLE also depends on the specific cultural context it is implemented in.17 18 While certain elements of ENABLE such as symptom control might be universal among HF patients of different cultures, we expect that there would be differing socio-cultural attitudes and expectations in Asian HF patients regarding healthcare, treatments, decision making and care planning. For example, a study published in 2018 showed that only 22% of HF patients in Singapore had an accurate understanding of their expected illness trajectory and knew that their treatments were not curative.19 With regards to decision making, it has been found that decision making in the Asian setting is often family-centric and less individual-centric as compared with the Western setting.20 21
Our study team had previously conducted semi-structured interviews to culturally adapt the content of the ENABLE programme to suit Asian socio-cultural attitudes to health coaching (manuscript under review). We found that participants preferred having a consistent nurse coach who would be able to individualise coaching content to their specific needs. Flexibility in programme session delivery and mode of coaching was also emphasised. The overall aim in this study was to take the next step to pilot this culturally adapted version of ENABLE in Singapore to assess the feasibility of recruitment and the feasibility, acceptability and efficacy of health coaching. If feasibility, acceptability and efficacy endpoints were met, we would proceed to a phase III confirmatory trial of ENABLE in Singapore.
Methods
Study setting, design and participants
This pilot was conducted in the outpatient setting of the National Heart Centre Singapore (NHCS). NHCS is a national and regional centre for cardiac diseases, handling over 120 000 outpatient consultations each year.22
A non-blinded, parallel arm (intervention vs wait-list usual care) Simon’s randomised phase II trial design was used for this study.23 Patient and caregivers were recruited as dyads. Eligible patient-caregiver dyads were randomised via a web-based randomisation programme to either intervention or wait-list control in a 1:1 ratio using the randomised permuted block method, stratified by functional status (New York Heart Association (NYHA) class 2 vs 3 and 4). The randomisation scheme was generated by the study statistician, with block size kept unknown to all other research personnel. Participants in the intervention arm were started on the ENABLE programme at point of randomisation while participants on wait-list were started on ENABLE 6 months after randomisation. A 6-month wait-list period was chosen to account for the entire intervention period of ENABLE and ensure comparability of the timing of primary endpoint assessment in terms of both time-on-study and time-since-intervention for both groups.
Patient participants had to be 21 years or older, able to communicate in English or Chinese, had a diagnosis of HF (American Heart Association Stage C or D) be of NYHA class 2, 3 or 4 as determined by their HF clinician, have a prognosis of 6 months and have been hospitalised in prior 6 months. Patients should be on disease-directed HF management. Patients already known to a palliative care service were excluded. Recruited caregivers had to be 21 years or above, a family member and able to speak English or Chinese. The nominated caregiver should be the person who was taking care of the patient’s day-to-day and healthcare needs, and/or ensuring provision of care to meet the needs, and/or the patient’s healthcare decision maker.
Patient and public involvement
No patients or public were involved in the design, or conduct, or reporting, or dissemination of our research.
Intervention-ENABLE programme
Online supplementary table 1 describes the ENABLE activities in detail. Briefly, the programme starts with a comprehensive palliative care assessment with a palliative care physician and nurse to document the patient’s understanding of their illness, goals of care, identified problems causing distress, social history and care setup. This is followed by a series of nurse coach led health coaching sessions for both patients and caregivers. The manualised health coaching curriculum is called ‘Charting Your Course’. Patient topics include ‘maintaining positivity’, ‘caring for yourself’, ‘an extra helping hand’, ‘being in control’, ‘talking about what matters most/making choices’, ‘sharing your journey’. Caregiver topics complement the patient topics, but from a caregiver’s perspective. They include ‘maintaining positivity’, ‘caring for yourself’, ‘being a partner in managing symptoms’, ‘talking about what matters most/making choices’. After the completion of health coaching, participants would receive follow-up phone calls to review their coping. Coaching of these topics was conducted 1 week apart, and all health coaching topics would be finished by the end of month 2.
Each session would start with the nurse evaluating the patient’s and caregiver’s self-reported distress using the Distress Thermometer, a tool validated in the HF population for general screening of distress.23 Nurses also characterised problems detected on the Distress Thermometer with the Integrated Palliative Care Outcome Scale, a measure that has been validated in the HF population in the UK and in Singapore.24,26 The findings from the distress thermometer and integrated palliative care outcome scale screening were used to guide focus areas for the health coaching sessions. Findings did not determine any clinical treatments a patient received. Though patients and caregivers were recruited in dyads, patients were allowed to have their sessions conducted separately from their caregivers (if requested), each at a selected time of their convenience, but in the same sequence. The ENABLE nurse would either hold sessions face-to-face or virtually through a secure mode of internet communications, depending on participant preference. Each health coaching session was done by the same nurse and would last approximately 1 hour. After the completion of health coaching sessions, participants would receive monthly follow-up phone calls. The entire programme from start to end of follow-ups is estimated to last 6 months.
The nurse involved was a specialist palliative care nurse working in the department at the time of the study. Prior to conducting the ENABLE intervention, the nurse participated in structured online training around health coaching and assessments (including that for usage of distress thermometer), as provided by the ENABLE team from the USA.
Wait-list usual care
Participants in usual care continued to be followed by their cardiologist during the 6-month wait-list period. If their HF clinician deemed it required based on their clinical assessment, they could be referred to palliative care services.
Recruitment and data collection
Recruitment started on 17 February 2022 and ended on 17 October 2023. The last point of follow-up with a trial participant was on 25 September 2024. Recruitment and data collection were carried out by a research coordinator who had no dependent relationship with potential participants. Patient lists from a list of HF clinics in NHCS (inclusive of a clinic led by a cardiologist in the study research team) were pre-screened for eligibility by the coordinator. Patients were only approached if the primary HF clinician running the clinic also agreed that patients fulfilled the inclusion criteria. Patient- or caregiver-reported outcome measures were administered in English or Chinese according to the participant’s preferred language and using the official translated versions. These were collected at baseline and every 3 months, till the end of month 6 for participants in the intervention group and till the end of month 12 for participants in the wait-list group. The study assessment schedule is shown in online supplemental table 2.
Outcome measures and endpoints
Feasibility endpoints included the proportion of eligible patient-caregiver dyads who were approached and consented to participate in ENABLE, and the proportion of recruited participants who completed health coaching. This was defined a priori as being able to recruit 80% of eligible participant dyads and have 80% of recruited participants complete health coaching. The acceptability endpoint was defined by the study team to be the proportion of participants who scored at least 12 (out of a maximum of 16) on the Client Satisfaction Questionnaire 4 Item (CSQ-4) survey,27 as this meant the participant had given an average score of 3 out of 4 for each item on the CSQ-4, indicating ‘satisfaction with ENABLE’. In a previous study that our team had done in Singapore, we used the same cut-off score.28 We determined a priori a target that at least 80% of participants would be satisfied with ENABLE. This a priori target was determined based on previous public healthcare satisfaction surveys.29
Efficacy endpoints included self-reported measures of QOL, anxiety, depression and spirituality of patients and caregivers. Primary efficacy outcome measure was change in patient’s QOL at 6 months from baseline, assessed using the total (overall summary) score of the Kansas City Cardiomyopathy Questionnaire (KCCQ),30 with the target effect size (Cohen’s d) being at least 0.25 SD in favour of ENABLE. Caregiver’s QOL was assessed using the Singapore Caregiver Quality of Life Scale (SCQOLS).31 Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS),32 33 and spirituality was assessed using the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale (FACIT-Sp-12).7 34 Except for HADS, a higher score represented a better outcome. These tools were chosen as they have either been used in the cardiac setting, and/or in the Singapore setting, thus making them valid and reliable for use in this study.
Statistical analysis
KCCQ, SCQOLS, HADS, FACIT-Sp-12 and CSQ-4 scores were derived according to their scoring guidelines. No imputation for missing data was performed. For the endpoints of feasibility of completing health coaching, our analysis excluded those who stopped health coaching for reasons that were not related to the health coaching intervention itself. For acceptability, only participants who completed health coaching and the CSQ-4 questionnaire were included in the analysis. For efficacy, the focus was on the estimation of the between-arm differences of each endpoint at 3 months and 6 months. Efficacy endpoint was met if the point estimate of difference in mean KCCQ total score at 6 months was at least 0.25 SD in favour of ENABLE, as per Simon’s phase II trial design.35 The mean and SE of KCCQ scores of each study arm at each assessment timepoint were estimated based on a mixed-effects linear regression model. Patients who had non-missing efficacy endpoints at either baseline, 3 months or 6 months were included in the analysis. The model included study arm, indicator variables for post-baseline assessment timepoints interaction terms between the time variables and study arm, and NYHA functional status as fixed-effects, patient-specific random intercepts and a first-order autoregressive covariance matrix. Estimates of between-arm differences in mean KCCQ scores at 3 months and 6 months were further adjusted for baseline KCCQ scores. In this analysis, those who had missing KCCQ scores at both 3 months and 6 months were excluded from the analysis. As the variance of random effects was zero after the inclusion of baseline scores, random intercepts were removed from the baseline score-adjusted models. Similar regression analyses were conducted for SCQOLS, HADS and FACIT-Sp-12 scores. Cohen’s d effect size was estimated as the difference in mean change in KCCQ total score from baseline to 6 months between the two study arms divided by the pooled SD of change in KCCQ total score from baseline to 6 months.
Sample size calculation
Assuming that the true percentage of acceptability and feasibility endpoints was 80%, a total sample size of 46 patients (23 per arm) would enable the 95% CI of each of these endpoints to be estimated with a 12% margin of error. In addition, a total of 46 patients (23 per arm) would provide 80% probability of showing a higher point estimate of KCCQ total score for the intervention arm as compared with the control arm, if the true effect size is at least 0.25 SD in favour of ENABLE.35 Considering a possible attrition rate of about 30%, the total sample size required was 60 patients (30 per arm). As patients and caregivers were to be recruited in pairs, 60 caregivers (30 per arm) would also be recruited. The trial stopped recruitment when the required sample size was acquired.
Results
Feasibility endpoint 1: approach to recruitment
Figure 1 shows the consort diagram of our study. Out of 167 potential dyads, 3 (1.8%) dyads were missed, 88 (52.7%) dyads declined participation due to lack of time or interest and 15 (9.0%) dyads did not respond to the invitation to participate. Our study team did not recruit one dyad (0.6%) as the dyad requested coaching only on weekends, which we could not accommodate. Eventually, 60 dyads were recruited, of which 29 dyads were allocated to the intervention arm and 31 dyads to the wait-list usual care arm. Excluding non-approached participants, the percentage of eligible participants who consented out of those approached was 36.6% (95% CI 29.2% to 44.5%).
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) diagram. ˆOther reasons included: patient condition changed and thereafter assessed to benefit more from community nursing (1 dyad), deteriorating health (1 cg). *Other reasons included: patient’s deteriorating health (1 pt), change of caregiver for patient (1 cg) and study team error in tracking the timeline of surveys (2 pts, 1 cg). **Analysed for feasibility/acceptability: 27 pts, 24 cgs from intervention arm; 22 pts, 21 cgs from wait-list. ˆˆAnalysed for efficacy: 29 pts, 29 cgs from intervention arm; 31 pts, 31 cgs from wait-list arm. cg, caregiver; pt, patient.
Demographics
Tables1 2 describe demographic details of the patients and caregivers, respectively. The ethnic composition of the participants in this study was like that of the general population, where 71.7% were Chinese.36 75.0% of participants were male, 85.0% married and 83.3% had secondary school education or above. More than a third (36.7%) were still working at the time of participation. Most (78.3%) had NYHA 2 symptoms.
Table 1. Characteristics of patients by study arm.
| Total | Intervention | Wait-list control | ||||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| Number of randomised patients | 60 | 100 | 29 | 100 | 31 | 100 |
| Age, years | ||||||
| Median (IQR) | 63 (51–70) | 64 (52–70) | 62 (48–70) | |||
| Gender | ||||||
| Female | 15 | 25 | 8 | 27.6 | 7 | 22.6 |
| Male | 45 | 75 | 21 | 72.4 | 24 | 77.4 |
| Ethnicity | ||||||
| Chinese | 43 | 71.7 | 20 | 69 | 23 | 74.2 |
| Malay | 12 | 20 | 7 | 24.1 | 5 | 16.1 |
| Indian | 4 | 6.7 | 1 | 3.4 | 3 | 9.7 |
| Eurasian | 1 | 1.7 | 1 | 3.4 | 0 | 0 |
| Marital status | ||||||
| Married | 51 | 85 | 23 | 79.3 | 28 | 90.3 |
| Single | 4 | 6.7 | 2 | 6.9 | 2 | 6.5 |
| Separated/Divorced | 2 | 3.3 | 2 | 6.9 | 0 | 0 |
| Widowed | 3 | 5 | 2 | 6.9 | 1 | 3.2 |
| Education level | ||||||
| No formal education | 1 | 1.7 | 1 | 3.4 | 0 | 0 |
| Primary | 9 | 15 | 3 | 10.3 | 6 | 19.4 |
| Secondary or ITE | 21 | 35 | 8 | 27.6 | 13 | 41.9 |
| Post-secondary and above | 29 | 48.3 | 17 | 58.6 | 12 | 38.7 |
| Economic status | ||||||
| Full time employment | 17 | 28.3 | 7 | 24.1 | 10 | 32.3 |
| Part time employment | 1 | 1.7 | 1 | 3.4 | 0 | 0 |
| Self-employed | 3 | 5 | 3 | 10.3 | 0 | 0 |
| Freelancing | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Unemployed | 22 | 36.7 | 9 | 31 | 13 | 41.9 |
| Retired | 14 | 23.3 | 8 | 27.6 | 6 | 19.4 |
| Others | 2 | 3.3 | 1 | 3.4 | 1 | 3.2 |
| NYHA functional status | ||||||
| 2 | 47 | 78.3 | 23 | 79.3 | 24 | 77.4 |
| 3–4 | 13 | 21.7 | 6 | 20.7 | 7 | 22.6 |
ITE, Institute of Technical Education; NYHA, New York Heart Association.
Table 2. Characteristics of caregivers by study arm.
| Total | Intervention | Wait-list control | ||||
|---|---|---|---|---|---|---|
| n | n | % | n | % | n | % |
| Number of randomised caregivers | 60 | 100 | 29 | 100 | 31 | 100 |
| Age, years | ||||||
| Median (IQR) | 56.5 (45.5–65) | 56 (52–65) | 57 (43–64) | |||
| Gender | ||||||
| Female | 47 | 78.3 | 23 | 79.3 | 24 | 77.4 |
| Male | 13 | 21.7 | 6 | 20.7 | 7 | 22.6 |
| Ethnicity | ||||||
| Chinese | 42 | 70 | 20 | 69 | 22 | 71 |
| Malay | 12 | 20 | 7 | 24.1 | 5 | 16.1 |
| Indian | 4 | 6.7 | 1 | 3.4 | 3 | 9.7 |
| Eurasian | 1 | 1.7 | 1 | 3.4 | 0 | 0 |
| Missing | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Marital status | ||||||
| Married | 52 | 86.7 | 27 | 93.1 | 25 | 80.6 |
| Single | 6 | 10 | 1 | 3.4 | 5 | 16.1 |
| Separated/divorced | 0 | 0 | 0 | 0 | 0 | 0 |
| Widowed | 2 | 3.3 | 1 | 3.4 | 1 | 3.2 |
| Education level | ||||||
| No formal education | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Primary | 5 | 8.3 | 1 | 3.4 | 4 | 12.9 |
| Secondary or ITE | 28 | 46.7 | 16 | 55.2 | 12 | 38.7 |
| Post-secondary and above | 25 | 41.7 | 12 | 41.4 | 13 | 41.9 |
| Missing | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Economic status | ||||||
| Full time employment | 19 | 31.7 | 8 | 27.6 | 11 | 35.5 |
| Part time employment | 5 | 8.3 | 2 | 6.9 | 3 | 9.7 |
| Self-employed | 4 | 6.7 | 2 | 6.9 | 2 | 6.5 |
| Freelancing | 3 | 5 | 1 | 3.4 | 2 | 6.5 |
| Unemployed | 10 | 16.7 | 4 | 13.8 | 6 | 19.4 |
| Retired | 9 | 15 | 7 | 24.1 | 2 | 6.5 |
| Homemaker | 5 | 8.3 | 2 | 6.9 | 3 | 9.7 |
| Others | 3 | 5 | 2 | 6.9 | 1 | 3.2 |
| Missing | 2 | 3.3 | 1 | 3.4 | 1 | 3.2 |
| Relationship with patient | ||||||
| Spouse | 40 | 66.7 | 19 | 65.5 | 21 | 67.7 |
| Children | 10 | 16.7 | 4 | 13.8 | 6 | 19.4 |
| Sibling | 2 | 3.3 | 0 | 0 | 2 | 6.5 |
| Friend | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Parent | 4 | 6.7 | 3 | 10.3 | 1 | 3.2 |
| Others | 3 | 5 | 3 | 10.3 | 0 | 0 |
| Sole caregiver for patient | ||||||
| Yes | 37 | 61.7 | 20 | 69 | 17 | 54.8 |
| No | 22 | 36.7 | 9 | 31 | 13 | 41.9 |
| Missing | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Caring for someone else other than patient | ||||||
| Yes | 12 | 20 | 5 | 17.2 | 7 | 22.6 |
| No | 47 | 78.3 | 24 | 82.8 | 23 | 74.2 |
| Missing | 1 | 1.7 | 0 | 0 | 1 | 3.2 |
| Living with patient | ||||||
| Yes | 55 | 91.7 | 26 | 89.7 | 29 | 93.5 |
| No | 5 | 8.3 | 3 | 10.3 | 2 | 6.5 |
| Have an underlying medical condition | ||||||
| Yes | 15 | 25 | 8 | 27.6 | 7 | 22.6 |
| No | 45 | 75 | 21 | 72.4 | 24 | 77.4 |
| Any medical appointment in past 3 months | ||||||
| Yes | 16 | 26.7 | 10 | 34.5 | 6 | 19.4 |
| No | 44 | 73.3 | 19 | 65.5 | 25 | 80.6 |
| Any inpatient admission in past 3 months | ||||||
| Yes | 2 | 3.3 | 2 | 6.9 | 0 | 0 |
| No | 58 | 96.7 | 27 | 93.1 | 31 | 100 |
ITE, Institute of Technical Education.
From the first comprehensive palliative care assessment, nearly 95.9% reported that they thought that the goal of their HF treatment was either aimed towards cure or life-prolongation. Most had not completed any form of care planning such as an advanced medical directive (87.5%), advance care plan (83.3%) or lasting power of attorney (81.3%). Median Distress Thermometer scores of patients and caregivers were low (3 and below). Problems that distressed patients were more commonly related to physical (64.6%) or practical problems (45.8%) than family (20.8%) or emotional (25.0) problems. Further details on the problems that distressed patients on the Distress Thermometer are available in online supplemental table 3.
The composition of our caregiver participants mirrored national caregiver demographics,37 where 78.3% were female, 70.0% were Chinese, 86.7% were married and 88.4% had secondary school education and above. Compared with patients, more caregivers (51.7%) were working. Most were the spouse (66.7%) of the patient and the sole caregiver (61.7%). Most of them lived with the patient (91.7%) and 78.3% had only one person to care for. Majority (75.0%) reported no underlying medical condition or recent medical appointment (73.3%) or inpatient admission (96.7%).
Feasibility endpoint 2: completion of health coaching
Figure 1 shows the flow of participants through the study timepoints. A higher number of participants in the intervention arm (27 patients, 24 caregivers) started on the health coaching aspects of ENABLE than the wait-list usual care arm (21 patients, 20 caregivers). Out of those who started, a high number of participants in both arms completed health coaching—24 patients (88.9%) and 23 caregivers (95.8%) in the intervention arm and 20 patients (95.2%) and 20 caregivers (100.0%) in the wait-list arm.
Acceptability endpoint
Overall, the satisfaction of participants with the programme was high. The percentages of patients who scored at least 12 points out of a maximum of 16 points on the CSQ-4 were similar between study arms. Specifically, it was 85.7% in the intervention arm and 87.5% in the wait-list arm. The percentage of satisfied caregivers was 100% in the intervention arm and 87.5% in the wait-list arm.
Efficacy endpoints for patients
Table 3 describes the patient-reported outcomes of intervention and wait-list arm participants at baseline, 3 months and 6 months, the within arm change between baseline, 3 months and 6 months, and the differences between arms at 3 months and 6 months. While patients in both study arms had increases in mean KCCQ total score over time, larger increases were observed for patients in the intervention arm than those in the wait-list control arm. Specifically, the mean change from baseline (95% CI) in the intervention arm was 14.9 (6.3 to 23.5) versus 3.8 (−4.5 to 12.0) for the wait-list at 3 months. The change from baseline in the intervention arm was 16.6 (6.3 to 26.8) versus 6.9 (−1.2 to 15.1) for the wait-list at 6 months. After adjustment for baseline score, patients in the intervention arm had a higher mean KCCQ total score at 6 months than patients in the wait-list arm, by a difference of 12.4 (0.9 to 24.0). Estimated Cohen’s d was 0.43.
Table 3. Patient quality of life (KCCQ), anxiety/depression (HADS), spirituality outcomes (FACIT-Sp-12) by study arm.
| Mean (SE) | Change from baseline score | Difference in score | |||||
|---|---|---|---|---|---|---|---|
| (SE) (95% CI) | (intervention−control), | ||||||
| adjusted for baseline score (SE) (95% CI) | |||||||
| Baseline | Month 3 | Month 6 | Month 3 | Month 6 | Month 3 | Month 6 | |
| KCCQ | |||||||
| Total score | |||||||
| Intervention (n=28)† | 60.9 (4.4) | 75.8 (4.8) | 77.4 (5.6) | 14.9 (4.3) (6.3 to 23.5) | 16.6 (5.2) (6.3 to 26.8) | 13.7 (5.2) | 12.4 (5.8) |
| Wait-list control (n=31) | 56.3 (4.2) | 60.0 (4.6) | 63.2 (4.5) | 3.8 (4.2) (−4.5 to 12.0) | 6.9 (4.1) (−1.2 to 15.1) | (3.4 to 24.0) | (0.9 to 24.0) |
| Physical limitation | |||||||
| Intervention (n=28)† | 65.8 (5.1) | 74.5 (5.7) | 78.4 (6.5) | 8.7 (5.4) (−2.0 to 19.4) | 12.6 (6.2) (0.3 to 24.9) | 8.5 (7.0) | 12.0 (7.6) |
| Wait-list control (n=31) | 60.2 (4.8) | 60.8 (5.4) | 64.0 (5.3) | 0.6 (5.0) (−9.4 to 10.7) | 3.8 (5.0) (−6.1 to 13.7) | (−5.5 to 22.5) | (−3.2 to 27.1) |
| Symptom frequency | |||||||
| Intervention (n=28)† | 73.4 (4.5) | 83.6 (5.0) | 87.1 (5.8) | 10.2 (5.0) (0.2 to 20.2) | 13.7 (5.7) (2.4 to 25.0) | 3.3 (5.1) | 8.4 (5.7) |
| Wait-list control (n=31) | 70.1 (4.3) | 79.9 (4.7) | 77.5 (4.7) | 9.7 (4.8) (0.2 to 19.3) | 7.4 (4.6) (−1.8 to 16.6) | (−6.8 to 13.3) | (−2.9 to 19.6) |
| Quality of life | |||||||
| Intervention (n=28)† | 51.4 (5.5) | 71.9 (6.1) | 71.8 (7.4) | 20.5 (6.2) (8.2 to 32.8) | 20.4 (7.5) (5.5 to 35.3) | 26.2 (7.8) | 16.8 (8.9) |
| Wait-list control (n=31) | 50.3 (5.2) | 45.8 (5.8) | 54.6 (5.8) | −4.5 (5.9) (−16.2 to 7.2) | 4.3 (5.9) (−7.3 to 15.9) | (10.7 to 41.6) | (−0.9 to 34.5) |
| Social limitation | |||||||
| Intervention (n=28)† | 51.1 (6.2) | 72.8 (6.8) | 73.3 (7.9) | 21.7 (5.9) (9.9 to 33.5) | 22.2 (7.1) (8.1 to 36.3) | 19.0 (6.7) | 9.7 (7.5) |
| Wait-list control (n=31) | 44.2 (6.0) | 52.3 (6.5) | 57.4 (6.6) | 8.1 (5.8) (−3.5 to 19.6) | 13.1 (5.9) (1.4 to 24.8) | (5.7 to 32.3) | (−5.3 to 24.6) |
| HADS | |||||||
| Anxiety | |||||||
| Intervention (n=27)* | 5.38 (0.96) | 4.19 (1.14) | 5.21 (1.23) | −1.19 (1.03) (−3.24 to 0.86) | −0.17 (1.12) (−2.38 to 2.05) | −2.25 (1.31) | −0.27 (1.36) |
| Wait-list control (n=31) | 6.16 (0.87) | 6.78 (0.97) | 5.64 (0.96) | 0.62 (0.85) (−1.07 to 2.30) | −0.52 (0.83) (−2.18 to 1.14) | (−4.88 to 0.38) | (−2.99 to 2.44) |
| Depression | |||||||
| Intervention (n=27)* | 5.08 (0.92) | 3.51 (1.10) | 4.00 (1.21) | −1.56 (1.02) (−3.59 to 0.46) | −1.07 (1.11) (−3.28 to 1.14) | −2.70 (1.33) | −1.48 (1.38) |
| Wait-list control (n=31) | 5.34 (0.84) | 6.32 (0.94) | 5.39 (0.93) | 0.98 (0.84) (−0.69 to 2.65) | 0.05 (0.83) (−1.60 to 1.69) | (−5.36 to −0.04) | (−4.22 to 1.27) |
| FACIT-Sp-12 | |||||||
| Total score | |||||||
| Intervention (n=28)† | 35.8 (2.0) | 39.4 (2.4) | 39.6 (2.6) | 3.6 (2.0) (−0.4 to 7.6) | 3.8 (2.3) (−0.7 to 8.4) | 5.6 (2.8) | 5.3 (2.9) |
| Wait-list control (n=31) | 31.4 (1.9) | 31.4 (2.0) | 31.6 (2.1) | 0.04 (1.7) (−3.3 to 3.3) | 0.2 (1.7) (−3.1 to 3.6) | (0.1 to 11.1) | (−0.5 to 11.0) |
| Meaning | |||||||
| Intervention (n=28)† | 12.6 (0.7) | 13.7 (0.8) | 13.6 (0.9) | 1.1 (0.7) (−0.4 to 2.6) | 1.0 (0.9) (−0.7 to 2.7) | 1.5 (1.0) | 1.8 (1.1) |
| Wait-list control (n=31) | 11.7 (0.6) | 11.7 (0.7) | 11.4 (0.7) | −0.1 (0.6) (−1.3 to 1.2) | −0.4 (0.6) (−1.6 to 0.9) | (−0.4 to 3.5) | (−0.3 to 3.9) |
| Peace | |||||||
| Intervention (n=28)† | 11.3 (0.8) | 13.2 (0.9) | 13.0 (1.0) | 1.9 (0.8) (0.3 to 3.5) | 1.7 (0.9) (−0.1 to 3.6) | 1.8 (1.0) | 1.3 (1.1) |
| Wait-list control (n=31) | 10.0 (0.7) | 10.7 (0.8) | 11.0 (0.8) | 0.6 (0.7) (−0.7 to 2.0) | 1.0 (0.7) (−0.4 to 2.4) | (−0.2 to 3.7) | (−0.8 to 3.5) |
| Faith | |||||||
| Intervention (n=28)† | 11.4 (1.0) | 12.5 (1.2) | 12.7 (1.3) | 1.1 (1.2) (−1.2 to 3.4) | 1.2 (1.2) (−1.2 to 3.7) | 2.7 (1.4) | 2.5 (1.4) |
| Wait-list control (n=31) | 9.6 (0.9) | 8.9 (1.0) | 9.3 (1.0) | −0.7 (1.0) (−2.6 to 1.2) | −0.3 (0.9) (−2.2 to 1.6) | (−0.1 to 5.5) | (−0.4 to 5.3) |
Shaded rows show values where the CI does not include 0.
Two patients did not fill in HADS questionnaire at all assessment timepoints.
One patient did not fill in KCCQ and FACIT-Sp-12 questionnaire at all assessment timepoints.
FACIT-Sp-12, Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale; HADS, Hospital Anxiety and Depression Scale; KCCQ, Kansas City Cardiomyopathy Questionnaire.
Compared with wait-list participants, mean anxiety scores of patients in the intervention arm at 3 months were reduced by −1.19 (−3.24 to 0.86), though improvements were not sustained at 6 months (table 3). Mean depression scores were also noted to drop at 3 months for those in the intervention arm by −1.56 (−3.59 to 0.46). This contrasted with the wait-list arm at 3 months, where there was a rise in depression scores by 0.62 (−1.07 to 2.30).
There were positive signals for spirituality scores noted for intervention arm patients at 3 months of 3.6 (−0.4 to 7.6) and at 6 months of 3.8 (−0.7 to 8.4) (table 3). There was practically no change in spirituality scores in the wait-list patients between baseline, 3 months and 6 months. Improvements for the intervention arm patients seemed to have been driven by an improvement in the peace subscale.
Online supplementary figure 1 shows the changes in the wait-list arm for patients at month 9 and month 12, after they were started on ENABLE. In general, wait-list arm participants had improvements in KCCQ, HADS and FACIT-Sp-12 scores after starting ENABLE, as per the trend seen in the intervention arm at month 3 and month 6.
Efficacy endpoints for caregivers
Table 4 describes the caregiver-reported outcomes by trial arms and time points. There were improvements noted in the SCQOLS total score for both arms at 3 months, where the mean change from baseline (95% CI) for the intervention arm and wait-list arm were 3.0 (−1.3 to 7.4) and 5.7 (2.0 to 9.4), respectively. Changes were not sustained at 6 months in both arms. After adjustment for baseline score, the mean difference (95% CI) between intervention and wait-list was −0.8 (−6.9 to 5.3) at 3 months and −1.7 (−8.1 to 4.8) at 6 months.
Table 4. Caregiver quality of life (SCQOLS), anxiety/depression (HADS), spirituality (FACIT-Sp-12) outcomes by study arm.
| Mean (SE) | Change from baseline score | Difference in score | |||||
|---|---|---|---|---|---|---|---|
| (SE) (95% CI) | (intervention−control), | ||||||
| adjusted for baseline score (SE) (95% CI) | |||||||
| Baseline | Month 3 | Month 6 | Month 3 | Month 6 | Month 3 | Month 6 | |
| SCQOLS | |||||||
| Total score | |||||||
| Intervention (n=27) | 73.8 (2.8) | 76.8 (3.1) | 72.6 (3.2) | 3.0 (2.2) (−1.3 to 7.4) | −1.1 (2.3) (−5.7 to 3.5) | −0.8 (3.0) | −1.7 (3.2) |
| Wait-list control (n=31) | 65.3 (2.6) | 71.1 (2.7) | 68.8 (2.9) | 5.7 (1.8) (2.0 to 9.4) | 3.4 (2.0) (−0.6 to 7.5) | (−6.9 to 5.3) | (−8.1 to 4.8) |
| Physical well-being | |||||||
| Intervention (n=27)† | 76.4 (3.4) | 81.2 (3.9) | 76.2 (4.0) | 4.7 (3.3) (−1.9 to 11.3) | −0.2 (3.4) (−7.1 to 6.6) | 2.1 (4.1) | −2.3 (4.4) |
| Wait-list control (n=31) | 69.9 (3.2) | 75.1 (3.4) | 74.9 (3.6) | 5.2 (2.8) (−0.4 to 10.7) | 4.9 (3.0) (−1.1 to 11.0) | (−6.2 to 10.3) | (−11.0 to 6.5) |
| Mental well-being | |||||||
| Intervention (n=27)† | 72.5 (3.9) | 74.1 (4.3) | 69.3 (4.5) | 1.7 (3.4) (−5.0 to 8.4) | −3.2 (3.6) (−10.4 to 4.0) | −1.5 (4.3) | −2.6 (4.6) |
| Wait-list control (n=31) | 63.6 (3.6) | 69.8 (3.8) | 68.2 (4.0) | 6.2 (2.8) (0.6 to 11.8) | 4.7 (3.2) (−1.7 to 11.0) | (−10.1 to 7.1) | (−11.8 to 6.6) |
| Experience & meaning | |||||||
| Intervention (n=27)† | 67.9 (4.3) | 72.6 (4.9) | 64.6 (5.3) | 4.7 (4.2) (−3.7 to 13.0) | −3.3 (4.9) (−13.1 to 6.4) | 1.1 (5.5) | 0.3 (5.9) |
| Wait-list control (n=31) | 57.2 (4.0) | 64.6 (4.3) | 58.2 (4.6) | 7.4 (3.5) (0.4 to 14.4) | 1.0 (4.2) (−7.5 to 9.4) | (−9.8 to 11.9) | (−11.5 to 12.1) |
| Impact on daily life | |||||||
| Intervention (n=27)† | 81.8 (3.7) | 80.7 (4.3) | 79.3 (4.4) | −1.1 (3.8) (−8.7 to 6.5) | −2.5 (4.0) (−10.4 to 5.4) | −1.7 (4.8) | −1.4 (5.1) |
| Wait-list control (n=31) | 72.9 (3.5) | 78.1 (3.7) | 77.4 (4.0) | 5.1 (3.2) (−1.3 to 11.6) | 4.5 (3.5) (−2.5 to 11.5) | (−11.3 to 8.0) | (−11.4 to 8.7) |
| Financial well-being | |||||||
| Intervention (n=27)† | 64.5 (6.4) | 73.8 (7.1) | 71.3 (7.3) | 9.3 (5.2) (−1.1 to 19.7) | 6.9 (5.5) (−4.0 to 17.7) | 11.3 (6.3) | 11.5 (6.7) |
| Wait-list control (n=31) | 54.7 (6.0) | 56.0 (6.3) | 52.6 (6.6) | 1.3 (4.4) (−7.4 to 10.0) | −2.1 (4.8) (−11.6 to 7.5) | (−1.4 to 23.9) | (−1.9 to 24.8) |
| HADS | |||||||
| Anxiety | |||||||
| Intervention (n=27)† | 6.00 (0.83) | 5.15 (1.00) | 5.47 (0.98) | −0.85 (0.83) (−2.50 to 0.80) | −0.54 (0.82) (−2.17 to 1.10) | −0.48 (1.01) | 0.59 (1.06) |
| Wait-list control (n=31) | 6.27 (0.78) | 5.99 (0.84) | 5.22 (0.90) | −0.28 (0.65) (−1.58 to 1.02) | −1.05 (0.73) (−2.50 to 0.39) | (−2.50 to 1.54) | (−1.52 to 2.69) |
| Depression | |||||||
| Intervention (n=27)† | 4.79 (0.73) | 4.08 (0.93) | 3.95 (0.91) | −0.72 (0.91) (−2.53 to 1.10) | −0.84 (0.88) (−2.59 to 0.91) | −1.19 (1.04) | −0.52 (1.06) |
| Wait-list control (n=31) | 6.00 (0.68) | 5.98 (0.75) | 5.37 (0.82) | −0.02 (0.73) (−1.47 to 1.44) | −0.63 (0.78) (−2.18 to 0.92) | (−3.26 to 0.89) | (−2.64 to 1.61) |
| FACIT-Sp-12 | |||||||
| Total score | |||||||
| Intervention (n=26)* | 35.3 (2.1) | 38.4 (2.6) | 36.8 (2.5) | 3.1 (2.3) (−1.4 to 7.6) | 1.6 (2.2) (−2.8 to 5.9) | 5.5 (2.7) | 3.7 (2.7) |
| Wait-list control (n=31) | 30.2 (1.9) | 30.0 (2.0) | 30.3 (2.1) | −0.2 (1.7) (−3.7 to 3.3) | 0.1 (1.8) (−3.5 to 3.7) | (0.04 to 10.9) | (−1.7 to 9.1) |
| Meaning | |||||||
| Intervention (n=26)* | 12.6 (0.7) | 14.0 (0.9) | 13.3 (0.9) | 1.4 (0.8) (−0.2 to 3.1) | 0.8 (0.8) (−0.8 to 2.4) | 2.3 (1.0) | 1.4 (1.0) |
| Wait-list control (n=31) | 11.5 (0.6) | 11.2 (0.7) | 11.5 (0.7) | −0.3 (0.6) (−1.6 to 1.0) | −0.1 (0.7) (−1.4 to 1.3) | (0.3 to 4.4) | (−0.6 to 3.5) |
| Peace | |||||||
| Intervention (n=26)* | 11.0 (0.8) | 12.0 (1.0) | 12.5 (0.9) | 1.0 (0.9) (−0.7 to 2.7) | 1.5 (0.8) (−0.2 to 3.1) | 1.4 (1.1) | 1.6 (1.1) |
| Wait-list control (n=31) | 9.7 (0.7) | 9.8 (0.8) | 10.1 (0.8) | 0.1 (0.7) (−1.2 to 1.5) | 0.4 (0.7) (−1.0 to 1.7) | (−0.7 to 3.6) | (−0.5 to 3.8) |
| Faith | |||||||
| Intervention (n=26)* | 11.7 (1.0) | 12.3 (1.3) | 11.0 (1.2) | 0.6 (1.0) (−1.4 to 2.6) | −0.7 (1.0) (−2.6 to 1.3) | 1.4 (1.3) | 0.4 (1.3) |
| Wait-list control (n=31) | 9.0 (1.0) | 8.9 (1.0) | 8.8 (1.0) | −0.01 (0.8) (−1.5 to 1.5) | −0.1 (0.8) (−1.7 to 1.5) | (−1.2 to 4.0) | (−2.2 to 2.9) |
Shaded rows indicate those where the 95% CI did not include 0.
Three caregivers did not fill in FACIT-Sp-12 questionnaire at all assessment timepoints.
Two caregivers did not fill in SCQOLS and HADS questionnaire at all assessment timepoints.
FACIT-Sp-12, Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale; HADS, Hospital Anxiety and Depression Scale; SCQOLS, Singapore Caregiver Quality of Life Scale.
Mean anxiety score of caregivers in the intervention arm was reduced at 3 months by −0.85 (−2.50 to 0.80). This was a larger decrease than the wait-list arm of −0.28 (−1.58 to 1.02). Improvements in anxiety were not sustained. Depression scores dropped in both intervention and wait-list arm over time between baseline, 3 months and 6 months. The largest improvement from baseline was at the 6-month time point, where the intervention arm scores decreased by −0.84 (−2.59 to 0.91), and the wait-list arm scores decreased by −0.63 (−2.18 to 0.92).
Mean FACIT-Sp-12 total score of caregivers in the intervention arm increased over time, while there was practically no change over time in the wait-list arm caregivers. The mean difference in the intervention arm and wait-list arm was 5.5 (0.04 to 10.9) at 3 months and 3.7 (−1.7 to 9.1) at 6 months. Increases were mainly driven by positive changes in the meaning subscale.
Online supplementary figure 2 shows the changes in the wait-list arm for caregivers at month 9 and month 12, after they were started on ENABLE. In general, there were improvements in SCQOLS, HADS and FACIT-Sp-12 for the wait-list participants, as per the trends seen in the intervention arm at month 3 and month 6.
Discussion
Principal findings
We conducted a wait-list randomised pilot study of the ENABLE programme in patients with HF, and their caregivers in a tertiary cardiac centre in Singapore to evaluate feasibility, acceptability and the potential efficacy of ENABLE. While the consent rate among screened and eligible dyads did not meet our first a priori feasibility target, for participants who did start on health coaching, the completion rate was high, and this satisfied our second a priori target for feasibility. Regarding acceptability, a large proportion of participants were satisfied. Finally, we observed a moderate Cohen’s d effect size of 0.43 for patient QOL in favour of ENABLE, meeting the endpoint for preliminary efficacy as per Simon’s design. There were also positive changes in patient and caregiver depression, anxiety and spirituality, though the improvement in anxiety scores was not sustained.
Meaning of this study
The findings have implications for subsequent phase III studies. First, in relation to study design, while a wait-list control design had been shown to be feasible in prior trials in Singapore for the cancer population,38 39 we noted that fewer wait-list participants started on the health coaching aspects of ENABLE than intervention-arm participants. It is plausible that patients with HF have less frequent appointments for evaluation and treatment than those with cancer, reducing their chances of staying engaged with the research team. In other settings that studied the use of wait-list design in HF patients, a similar finding could be seen in that the retention of wait-list patients was lower (60%) than that of intervention patients (79%).40 Subsequent phase III studies in the cardiac setting will need to consider ways to minimise drop-out of wait-list participants.
Second, regarding study participation units, requiring patients and caregivers to be recruited as dyads could have limited our recruitment speed. As a significant proportion of caregivers in Singapore are aged between 40 and 59 years and are gainfully employed,37 we hypothesise that this could have led to a high refusal rate for trial participation. Subsequent phase III studies could consider allowing patients and caregivers to be recruited as separate units, and this might mirror the provision of services in real-life.
Comparisons of our findings to other larger-scale studies on health coaching
We noted that acceptability scores from our participants were positive. While it was not within the scope of this report to delineate the mechanisms of how this was achieved, we hypothesise that allowing participants flexibility in choosing their preferred method of engagement and giving them autonomy over the timing of the sessions could have enhanced ENABLE’s acceptability. High acceptability scores could also have arisen from our nurse coach being able to build psychological safety and trust during the coaching process. Building psychological safety and trust during the coaching process has been described in a published editorial as a mechanism to improve the acceptability of health coaching.41
At this pilot stage, we also observed a positive efficacy signal of ENABLE. We hypothesise that a possible mechanism of this could be that health coaching can raise self-efficacy and activation, from which self-management and QOL can further improve.42 Regarding improvement in other outcomes such as patient and caregiver anxiety, depression and spirituality, our findings are similar to a 2019 systematic review which noted the positive impact of health coaching on QOL and depression, but less so on anxiety.43 In our phase III trial, we will further explore the impact of health coaching on anxiety.
Strengths and weaknesses of this study
Our study had several strengths and some limitations. This is, to our knowledge, the first palliative care randomised pilot study conducted in South-East Asia on the ENABLE programme for patients with HF. The centre chosen is a high-volume, national and regional referral centre for cardiac disease. The patient profile is diverse; representative of major ethnic groups present in Singapore and other South-East Asian countries.44 Findings would be of high value to inform advocacy of palliative care efforts in our South-East Asia region. Additionally, we have chosen a total of three end points of acceptability, feasibility and efficacy for investigation of ENABLE, allowing for a more robust evaluation of healthcare models, guided by Proctor et al.45 Limitations of this study were that health coaching was only conducted in the English and Chinese language, though these were chosen as they are the predominant languages of use in Singapore.46 Further work could be done to translate ENABLE to Malay and Tamil, to serve those who only speak these languages. Second, as it was a pilot study run by only one health coach, it was beyond the scope of this study to evaluate the feasibility of ensuring standardisation of training between health coaches, which would be essential in future large-scale phase III studies where it would be likely that more than one health coach would be needed. Additionally, as some of the participants could have been known to the study team, there could have been a potential selection bias, though all efforts were made during the consent process to reassure participants that their participation (or non-participation) would not affect the clinical care they would receive.
Conclusion and future studies
This pilot study found that ENABLE was acceptable, efficacious and overall feasible. Our team has consequently designed a phase III randomised controlled trial, comparing a nurse-led tiered model of care with usual care.47 This trial allows patients and caregivers to be recruited together, or patients to be recruited alone and will involve ENABLE health-coaching as one of the key tenets.
STRENGTHS AND LIMITATIONS OF THIS STUDY
First early palliative care randomised pilot study conducted in South-East Asia on the Educate, Nurture, Advise Before Life Ends (ENABLE) programme for patients with heart failure.
The study covered a diverse patient profile, representative of major ethnic groups within Singapore and other South-East Asian countries.
Total of three end points (acceptability, feasibility and efficacy) chosen, allowing for a more robust evaluation of ENABLE, guided by implementation science principles.
Health coaching was only conducted in the English and Chinese language. Further work could be done to translate ENABLE to Malay and Tamil, which are major languages in this region, to serve those who only speak these languages.
Pilot study was run by only one health coach, so the feasibility of ensuring standardisation of training between health coaches could not be evaluated.
Supplementary material
Footnotes
Funding: The project was funded by the Ministry of Health, Singapore, National Medical Research Council, Health Services New Investigator Grant. Project ID-MOH-000733-00; Award number MOH-HNIG20nov-0003.
Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-113749).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: All participants signed informed consent prior to starting the trial procedures. The study was reviewed and approved by the SingHealth Institutional Review Board – study number: 2021- 2722
Ethics approval: This study involves human participants and was approved by SingHealth Institutional Review Board, IRB number: 2021-2722 (email: irb@singhealth.com.sg). Participants gave informed consent to participate in the study before taking part.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Data availability statement
No data are available.
References
- 1.Ministry of Health Statistics Principal causes of death. [1-Aug-2025]; https://www.moh.gov.sg/others/resources-and-statistics/principal-causes-of-death Available. accessed.
- 2.Lam CSP. Heart Failure in Southeast Asia: Facts and Numbers. ESC Heart Fail. 2015;2:46–9. doi: 10.1002/ehf2.12036. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363:733–42. doi: 10.1056/NEJMoa1000678. [DOI] [PubMed] [Google Scholar]
- 4.Zimmermann C, Swami N, Krzyzanowska M, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014;383:1721–30. doi: 10.1016/S0140-6736(13)62416-2. [DOI] [PubMed] [Google Scholar]
- 5.Bakitas MA, Tosteson TD, Li Z, et al. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015;33:1438–45. doi: 10.1200/JCO.2014.58.6362. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Dionne-Odom JN, Azuero A, Lyons KD, et al. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015;33:1446–52. doi: 10.1200/JCO.2014.58.7824. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Rogers JG, Patel CB, Mentz RJ, et al. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017;70:331–41. doi: 10.1016/j.jacc.2017.05.030. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.McDonald J, Swami N, Hannon B, et al. Impact of early palliative care on caregivers of patients with advanced cancer: cluster randomised trial. Ann Oncol. 2017;28:163–8. doi: 10.1093/annonc/mdw438. [DOI] [PubMed] [Google Scholar]
- 9.McDonald J, Swami N, Pope A, et al. Caregiver quality of life in advanced cancer: Qualitative results from a trial of early palliative care. Palliat Med. 2018;32:69–78. doi: 10.1177/0269216317739806. [DOI] [PubMed] [Google Scholar]
- 10.Hoerger M, Greer JA, Jackson VA, et al. Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care. J Clin Oncol. 2018;36:1096–102. doi: 10.1200/JCO.2017.75.6676. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Wagner EH, Austin BT, Davis C, et al. Improving Chronic Illness Care: Translating Evidence Into Action. Health Aff (Millwood) 2001;20:64–78. doi: 10.1377/hlthaff.20.6.64. [DOI] [PubMed] [Google Scholar]
- 12.Bakitas M, Lyons KD, Hegel MT, et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009;302:741–9. doi: 10.1001/jama.2009.1198. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Bakitas M, Stevens M, Ahles T, et al. Project ENABLE: a palliative care demonstration project for advanced cancer patients in three settings. J Palliat Med. 2004;7:363–72. doi: 10.1089/109662104773709530. [DOI] [PubMed] [Google Scholar]
- 14.Dionne-Odom JN, Kono A, Frost J, et al. Translating and testing the ENABLE: CHF-PC concurrent palliative care model for older adults with heart failure and their family caregivers. J Palliat Med. 2014;17:995–1004. doi: 10.1089/jpm.2013.0680. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Bakitas MA, Dionne-Odom JN, Ejem DB, et al. Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial. JAMA Intern Med. 2020;180:1203–13. doi: 10.1001/jamainternmed.2020.2861. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Dionne-Odom JN, Ejem DB, Wells R, et al. Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial. JAMA Netw Open. 2020;3:e202583. doi: 10.1001/jamanetworkopen.2020.2583. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17.Skivington K, Matthews L, Simpson SA, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061. doi: 10.1136/bmj.n2061. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Malhotra C, Sim D, Jaufeerally F, et al. Associations between understanding of current treatment intent, communication with healthcare providers, preferences for invasive life-sustaining interventions and decisional conflict: results from a survey of patients with advanced heart failure in Singapore. BMJ Open. 2018;8:e021688. doi: 10.1136/bmjopen-2018-021688. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Tay K, Yu Lee RJ, Sim SW, et al. Cultural influences upon advance care planning in a family-centric society. Palliat Support Care. 2017;15:665–74. doi: 10.1017/S1478951516001139. [DOI] [PubMed] [Google Scholar]
- 21.Malhotra C, Sim D, Jaufeerally FR, et al. Impact of a Formal Advance Care Planning Program on End-of-Life Care for Patients With Heart Failure: Results From a Randomized Controlled Trial. J Card Fail. 2020;26:594–8. doi: 10.1016/j.cardfail.2020.01.015. [DOI] [PubMed] [Google Scholar]
- 22.National heart centre singapore. [15-Mar-2025]. https://www.nhcs.com.sg/about-us Available. Accessed.
- 23.Holly D, Sharp J. Distress thermometer validation: heart failure. British Journal of Cardiac Nursing. 2012;7:595–602. doi: 10.12968/bjca.2012.7.12.595. [DOI] [Google Scholar]
- 24.Murtagh FE, Ramsenthaler C, Firth A, et al. A brief, patient- and proxy-reported outcome measure in advanced illness: Validity, reliability and responsiveness of the Integrated Palliative care Outcome Scale (IPOS) Palliat Med. 2019;33:1045–57. doi: 10.1177/0269216319854264. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Kane PM, Ellis-Smith CI, Daveson BA, et al. Understanding how a palliative-specific patient-reported outcome intervention works to facilitate patient-centred care in advanced heart failure: A qualitative study. Palliat Med. 2018;32:143–55. doi: 10.1177/0269216317738161. [DOI] [PubMed] [Google Scholar]
- 26.Neo SH-S, Tan JY-T, Sim DK-L, et al. Validity and Reliability of the Integrated Palliative Care Outcome Scale in Asian Heart Failure Patients. Palliat Med Rep. 2022;3:287–95. doi: 10.1089/pmr.2022.0029. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Client satisfaction questionnaires. [11-Apr-2020]. https://csqscales.com/csq-versions/#CSQ-3 Available. Accessed.
- 28.Neo SH-S, Mok N, Ng X-H, et al. Enhancing palliative care for advanced cancer patients: evaluating implementation and impact of a virtual nurse-led symptom monitoring and telehealth initiative. BMC Palliat Care. 2024;23:238. doi: 10.1186/s12904-024-01541-0. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Channelnewsasia Public healthcare satisfaction up, but wait-time still a pain. [6-Apr-2026]. https://www.channelnewsasia.com/singapore/public-healthcare-satisfaction-up-wait-time-still-pain-5830106 Available. Accessed.
- 30.Green CP, Porter CB, Bresnahan DR, et al. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35:1245–55. doi: 10.1016/s0735-1097(00)00531-3. [DOI] [PubMed] [Google Scholar]
- 31.Cheung YB, Neo SHS, Teo I, et al. Development and evaluation of a quality of life measurement scale in English and Chinese for family caregivers of patients with advanced cancers. Health Qual Life Outcomes. 2019;17:35. doi: 10.1186/s12955-019-1108-y. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 32.Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x. [DOI] [PubMed] [Google Scholar]
- 33.Bambauer KZ, Locke SE, Aupont O, et al. Using the Hospital Anxiety and Depression Scale to screen for depression in cardiac patients. Gen Hosp Psychiatry. 2005;27:275–84. doi: 10.1016/j.genhosppsych.2005.03.002. [DOI] [PubMed] [Google Scholar]
- 34.Bredle JM, Salsman JM, Debb SM, et al. Spiritual Well-Being as a Component of Health-Related Quality of Life: The Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being Scale (FACIT-Sp) Religions (Basel) 2011;2:77–94. doi: 10.3390/rel2010077. [DOI] [Google Scholar]
- 35.Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep. 1985;69:1375–81. [PubMed] [Google Scholar]
- 36.Population-in-brief 2023. [7-Aug-2025];2023 https://www.population.gov.sg/files/media-centre/publications/population-in-brief-2023.pdf Available. accessed.
- 37.Zheng MZ. Singapore department of statistics. caregiving in singapore. 2025. https://www.singstat.gov.sg/-/media/files/publications/society/ssnsep11-pg12-14.pdf Available.
- 38.Teo I, Tan YP, Finkelstein EA, et al. The Feasibility and Acceptability of a Cognitive Behavioral Therapy-Based Intervention for Patients With Advanced Colorectal Cancer. J Pain Symptom Manage. 2020;60:1200–7. doi: 10.1016/j.jpainsymman.2020.06.016. [DOI] [PubMed] [Google Scholar]
- 39.Teo I, Vilardaga JP, Tan YP, et al. A feasible and acceptable multicultural psychosocial intervention targeting symptom management in the context of advanced breast cancer. Psychooncology. 2020;29:389–97. doi: 10.1002/pon.5275. [DOI] [PubMed] [Google Scholar]
- 40.DeGroot L, Gillette R, Villalobos JP, et al. Feasibility of a digital palliative care intervention (Convoy-Pal) for older adults with heart failure and multiple chronic conditions and their caregivers: a waitlist randomized control trial. BMC Palliat Care. 2024;23:234. doi: 10.1186/s12904-024-01561-w. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 41.Tan S. The role of health and wellness coaching in Healthier SG, Primary Care and Preventive Medicine. Singapore Fam Physician. 2024;50:9 [Google Scholar]
- 42.Lin M, Cheng S, Hou W, et al. Mechanisms and Effects of Health Coaching in Patients With Early‐Stage Chronic Kidney Disease: A Randomized Controlled Trial. J of Nursing Scholarship. 2021;53:154–60. doi: 10.1111/jnu.12623. [DOI] [PubMed] [Google Scholar]
- 43.Long H, Howells K, Peters S, et al. Does health coaching improve health-related quality of life and reduce hospital admissions in people with chronic obstructive pulmonary disease? A systematic review and meta-analysis. Br J Health Psychol. 2019;24:515–46. doi: 10.1111/bjhp.12366. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 44.Azad MdAK. South-East Asia: Unity in Diversity. DUS. 2023;79:15–32. doi: 10.62296/DUS202212002. [DOI] [Google Scholar]
- 45.Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38:65–76. doi: 10.1007/s10488-010-0319-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 46.Singapore population census. [6-Apr-2026];2020 https://assets.app.optical.gov.sg/singstat/production/published/assets/ 6a529fe2-6468-43df-9151-bfc9a0d2ad26.pdf Available. accessed.
- 47.Neo SH-S, Yu K, Lee CF, et al. 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;15:e100581. doi: 10.1136/bmjopen-2025-100581. [DOI] [PMC free article] [PubMed] [Google Scholar]