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.

Non-blinded randomised wait-list controlled pilot study, using Simon’s randomised phase II trial design.

Specialist outpatient clinics in a tertiary cardiac centre in Singapore.

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.

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.

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.

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.

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.

NCT05211882.

Secondary lower extremity lymphoedema is a chronic progressive condition that frequently develops after cancer treatment and results in persistent swelling, recurrent cellulitis and impaired quality of life. Lymphaticovenous anastomosis (LVA) is an established physiological microsurgical treatment; however, postoperative outcomes vary and evidence-based adjunctive postoperative management remains limited. A novel pneumatic lymphatic drainage (PLD) system has been developed to deliver anatomically directed, pathway-aligned mechanical stimulation that mimics manual lymphatic drainage. Its clinical efficacy following LVA has not yet been evaluated in a randomised controlled trial.

This multicentre, open-label, parallel-group randomised controlled trial will enrol adults (≥18 years) with unilateral secondary lower extremity lymphoedema (International Society of Lymphology stage I–II) undergoing LVA. Participants will be randomised 1:1 to receive PLD plus standard postoperative care or standard postoperative care alone. PLD will be initiated on the day of surgery and continue for 6 months (Day 183). The primary outcome is the rate of improvement in excess limb volume (EV) at Day 183 relative to baseline, calculated from circumferential measurements taken at 4 cm intervals using the truncated cone method, with the contralateral limb serving as an internal control. Secondary outcomes include longitudinal trajectories of EV, improvement in excess limb fluid volume assessed by bioimpedance, the Lymphedema Quality of Life Questionnaire, cellulitis incidence and safety outcomes. A total of 64 participants (32 per group) will provide 80% power (two-sided α=0.05) to detect a 15-percentage-point between-group difference in the rate of improvement in EV at 6 months, assuming a common SD of 20 percentage points and allowing for attrition. Primary analyses will follow the ITT principle using mixed-effects models for repeated measures.

The study was approved by the Chiba University Certified Review Board (approval number: CRB0119-25; approval date: 15 December 2025) and was conducted in accordance with the Declaration of Helsinki and the Japanese Clinical Trials Act. Results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences, irrespective of study outcomes.

jRCTs032250600.

To investigate the relationship between a quality of life (QOL) score and clinical parameters in patients with hypertrophic cardiomyopathy (HCM).

A multicentre cross-sectional study.

We analysed data from the Searching for Atrial Fibrillation and Early Recruitment of Heart Failure in HCM registry, collected between 2018 and 2023.

Patients with HCM (n=499) aged ≥18 years from 12 institutions (Shizuoka Prefecture, Japan) were consecutively enrolled.

Clinical parameters, along with data from a short form of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), were collected. The association between each clinical parameter and the KCCQ-12 score was analysed. Clinical parameters with a significant univariable association (p

In the univariable analysis, KCCQ-12 scores exhibited significant associations with 21 clinical parameters, including sex, left ventricular morphology and the Pittsburgh Sleep Quality Index (PSQI). The multiple regression model with 12 parameters that had a significant univariable association exhibited an adjusted R² of 0.48. In this model, the PSQI (standardised coefficient –0.39; p

In patients with HCM, we investigated the association between the KCCQ-12 score and various clinical parameters. PSQI, as well as known heart failure-related clinical parameters, was significantly associated with the KCCQ-12 score. Visualising the associations of various clinical parameters with the KCCQ-12 score will help physicians to consider factors linked to the decline in QOL in patients with HCM.

In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).

This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.

A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p

The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.

NCT04563546.

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

UMIN000052161.