Conectar
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.
Chronic non-healing wounds represent a major global public health challenge. Their persistence is frequently attributed to localized biological deficits that cause them unresponsive to conventional therapeutic modalities. While Platelet-Rich Plasma (PRP) has demonstrated promising results as an adjunctive treatment by delivering highly concentrated growth factors, its clinical application is currently impeded by a lack of clinical standardization, particularly optimal injection frequency, interval, and dosage. The aim of this study is to rigorously evaluate the efficacy and safety of a specific, non-intensive two-dose PRP injection protocol for accelerating the reduction of wound area in patients with various types of refractory chronic wounds. We conducted a prospective, single-arm, pretest-posttest study enrolling 18 patients with refractory non-healing wounds, defined as lesions persisting for a minimum period of 4 weeks which had failed to achieve definitive closure under optimized standard care. Autologous high-concentration PRP was injected intradermally around the wound margin at baseline (Day 0) and again 3 weeks later (Day 21). Wound area was digitally measured at baseline and subsequently at 7, 11 and 15 weeks. The primary outcome was the mean reduction in wound area (cm2) at the 15-week follow-up, assessed using a Paired Samples t-test. The mean patient age was 57.89 ± 15.64 years, and wounds had a mean chronicity of 15.83 ± 19.05 months. The PRP preparation achieved a mean platelet concentration 8.5 times greater than the peripheral blood threshold (first injection) and 7.0 times greater than the threshold (second injection), confirming high therapeutic quality. Analysis of the total cohort demonstrated a statistically significant reduction in mean wound area from baseline 27.41 ± 70.38 cm2 to 15 weeks 21.5 ± 68.96 cm2. Three patients (16.67%) achieved complete epithelialization. Subgroup trends suggested diabetic and venous ulcers responded more favourably than radiation-induced ulcers. The protocol was safe, with no systemic or severe localized adverse events observed among participants. The defined two-dose PRP injection protocol provides a clinically effective and safe adjunctive therapy that significantly promotes wound area reduction in challenging chronic non-healing wounds. This reproducible, low-frequency protocol offers a rationale for standardization in advanced wound care, warranting validation through future large-scale Randomized Controlled Trials (RCTs).
FreshRSS 