A randomized controlled trial evaluating a theory driven, complex intervention centered on task sharing and mobile health to improve selfcare and outcomes in heart failure - The PANACEA-HF RCT: Design and rationale.

Background: We developed a three-pronged complex intervention to improve selfcare and deliver whole person care for patients with heart failure, underpinned by the 'extant cycle' theory - a theory based on our formative work. Methods: This is a 3 centre, 2-arm, 1:1, open, adaptive stratified, randomized controlled trial. We included patients aged ≥ 18 years with heart failure, taking any of the key guideline directed medical treatments, with a history of or currently on a high ceiling diuretic. We excluded end stage renal disease, clinically diagnosed severe mental illness or cognitive dysfunction and having no caregivers. Interventions included, (i) trained hospital based lay health worker mediated assessment of patients' current selfcare behaviour, documenting barriers and facilitators and implementing a plan to 'transition' the patient toward optimal selfcare. (ii) m-health mediated remote monitoring and (iii) dose optimization through a 'physician supervisor'. Results: We recruited 301 patients between Jan 2021 and Jan 2022. Mean age was 59.8 (±11.7) years, with 195 (64.8 %) from rural or semi-urban areas and 67.1 % having intermediate to low health literacy. 190 (63.1 %) had an underlying ischemic cardiomyopathy. In the intervention arm, 142 (94.1 %) had a Selfcare in Heart Failure Index (SCHFI) score of ≤70, with significant barriers being 'lack of knowledge' 105 (34.5 %) and 'behavioural passivity' 23 (7.5 %). Conclusion: This is the first South Asian trial evaluating a complex intervention underpinned by behaviour change theory for whole person heart failure care. These learnings can be applied to heart failure patient care in other resource constrained health systems.

Patient and caregiver reported facilitators of self-care among patients with chronic heart failure: report from a formative qualitative study.

Background: Adherence to a complex, yet effective medication regimen improves clinical outcomes in patients with chronic heart failure (CHF). However, patient adherence to an agreed upon plan for medication-taking is sub-optimal and continues to hover at 50% in developed countries. Studies to improve medication-taking have focused on interventions to improve adherence to guideline-directed medication therapy, yet few of these studies have integrated patients' perceptions of what constitutes effective strategies for improved medication-taking and self-care in everyday life. The purpose of this formative study was to explore patient perceived facilitators of selfcare and medication-taking. Methods: We conducted in-depth interviews of patients with long standing heart failure admitted to the cardiology and internal medicine wards of a South Indian tertiary care hospital. We purposively sampled using the following criteria: sex, socio-economic status, health literacy and patient reported medication adherence in the month prior to hospitalization. We employed inductive coding to identify facilitators. At the end of 15 interviews (eight patients and seven caregivers; seven patient-caregiver dyads), we arrived at theoretical saturation for facilitators. Results: Facilitators could be classified into intrinsic (patient traits - situational awareness, self-efficacy, gratitude, resilience, spiritual invocation and support seeking behavior) and extrinsic (shaped by the environment - financial security and caregiver support, company of children, ease of healthcare access, trust in provider/hospital, supportive environment and recognizing the importance of knowledge). Conclusions: We identified and classified a set of key patient and caregiver reported self-care facilitators among Indian CHF patients. The learnings from this study will be incorporated into an intervention package to improve patient engagement, overall self-care and patient-caregiver-provider dynamics.