PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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\'.
UNASSIGNED: 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 %).
UNASSIGNED: 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.
UNASSIGNED: 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\'.
UNASSIGNED: 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 %).
UNASSIGNED: 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.
摘要：
我们开发了三管齐下的复杂干预措施，以改善自我护理并为心力衰竭患者提供全程护理，以“现存循环”理论为基础--一个基于我们形成工作的理论。
■这是一个3个中心，双臂，1:1，打开，自适应分层，随机对照试验。我们纳入了年龄≥18岁的心力衰竭患者，采取任何关键指南指导药物治疗，有历史或目前在高上限利尿剂。我们排除了终末期肾病，临床诊断为严重的精神疾病或认知功能障碍，并且没有护理人员。干预措施包括,(I)经过培训的基于医院的非专业卫生工作者对患者当前自我护理行为的评估，记录障碍和促进者，并实施一项计划，以使患者向最佳自我护理过渡。（ii）m-health介导的远程监测和（iii）通过“医师监督员”进行剂量优化。
■我们在2021年1月至2022年1月之间招募了301名患者。平均年龄59.8(±11.7)岁,195人(64.8%)来自农村或半城市地区，67.1%的人健康素养中等到较低。190（63.1％）患有潜在的缺血性心肌病。在干预臂中，142（94.1％）的心力衰竭指数（SCHFI）自我护理评分≤70，其中显着障碍是“缺乏知识”105（34.5％）和“行为被动”23（7.5％）。
这是第一个评估以行为改变理论为基础的复杂干预措施的南亚试验。这些学习可以应用于其他资源受限的卫生系统中的心力衰竭患者护理。
■这是一个3个中心，双臂，1:1，打开，自适应分层，随机对照试验。我们纳入了年龄≥18岁的心力衰竭患者，采取任何关键指南指导药物治疗，有历史或目前在高上限利尿剂。我们排除了终末期肾病，临床诊断为严重的精神疾病或认知功能障碍，并且没有护理人员。干预措施包括,(I)经过培训的基于医院的非专业卫生工作者对患者当前自我护理行为的评估，记录障碍和促进者，并实施一项计划，以使患者向最佳自我护理过渡。（ii）m-health介导的远程监测和（iii）通过“医师监督员”进行剂量优化。
■我们在2021年1月至2022年1月之间招募了301名患者。平均年龄59.8(±11.7)岁,195人(64.8%)来自农村或半城市地区，67.1%的人健康素养中等到较低。190（63.1％）患有潜在的缺血性心肌病。在干预臂中，142（94.1％）的心力衰竭指数（SCHFI）自我护理评分≤70，其中显着障碍是“缺乏知识”105（34.5％）和“行为被动”23（7.5％）。
这是第一个评估以行为改变理论为基础的复杂干预措施的南亚试验。这些学习可以应用于其他资源受限的卫生系统中的心力衰竭患者护理。
