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Abstract：
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication.
METHODS: The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done.
CONCLUSIONS: The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment.
BACKGROUND: The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.
METHODS: The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done.
CONCLUSIONS: The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment.
BACKGROUND: The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.
摘要：
背景：心血管疾病（CVD）是全球死亡的主要原因，目前,印度的急性冠脉综合征和ST段抬高型心肌梗死（MI）负担最高。结果不佳的一个关键原因是不坚持药物治疗。
方法：干预是一项2×2因子设计试验，分别应用两种干预措施，并结合1：1的分配比例：（i）ASHA主导的药物依从性倡议，包括家庭访视和（ii）使用提醒和自我报告药物使用的m-健康干预。此设计将导致四个潜在的实验条件：（i）ASHA主导的干预，(ii)m-健康干预，（iii）ASHA和m-健康干预组合，（四）护理标准。选择了集群随机试验，因为它随机化了社区而不是个人，避免参与者之间的污染。分中心是卫生系统的一个自然子集，它们将被视为集群/单元。因子聚类随机对照试验（cRCT）还将纳入嵌套的健康经济学评估，以评估CVD患者药物依从性干预措施的成本效益和投资回报率（ROI）。样本量已计算为每臂393人，每臂有4-5个子中心。进行过程评估，以了解干预措施在可接受性方面的效果，采用(吸收)，适当性，成本,可行性,保真度，渗透(在特定环境中整合实践)，可持续性将会实现。
结论：将使用涉及18个亚中心区域的整群随机设计来评估单独和组合的不同类型干预措施的效果。该试验将探索当地的知识和观念，并通过将服药依从性的责任转移到自己身上来赋予人们权力。该提案符合世卫组织-NCD的目标，即提高负担得起的基本技术和基本药物的可用性，培训卫生人力和加强初级保健一级的能力，解决非传染性疾病的控制问题。该提案还有助于扩大数字技术的使用，以增加非传染性疾病治疗的卫生服务机会和疗效，并可能有助于降低治疗成本。
背景：该试验已在印度临床试验注册中心（CTRI）注册，参考编号CTRI/2023/10/059095。
方法：干预是一项2×2因子设计试验，分别应用两种干预措施，并结合1：1的分配比例：（i）ASHA主导的药物依从性倡议，包括家庭访视和（ii）使用提醒和自我报告药物使用的m-健康干预。此设计将导致四个潜在的实验条件：（i）ASHA主导的干预，(ii)m-健康干预，（iii）ASHA和m-健康干预组合，（四）护理标准。选择了集群随机试验，因为它随机化了社区而不是个人，避免参与者之间的污染。分中心是卫生系统的一个自然子集，它们将被视为集群/单元。因子聚类随机对照试验（cRCT）还将纳入嵌套的健康经济学评估，以评估CVD患者药物依从性干预措施的成本效益和投资回报率（ROI）。样本量已计算为每臂393人，每臂有4-5个子中心。进行过程评估，以了解干预措施在可接受性方面的效果，采用(吸收)，适当性，成本,可行性,保真度，渗透(在特定环境中整合实践)，可持续性将会实现。
结论：将使用涉及18个亚中心区域的整群随机设计来评估单独和组合的不同类型干预措施的效果。该试验将探索当地的知识和观念，并通过将服药依从性的责任转移到自己身上来赋予人们权力。该提案符合世卫组织-NCD的目标，即提高负担得起的基本技术和基本药物的可用性，培训卫生人力和加强初级保健一级的能力，解决非传染性疾病的控制问题。该提案还有助于扩大数字技术的使用，以增加非传染性疾病治疗的卫生服务机会和疗效，并可能有助于降低治疗成本。
背景：该试验已在印度临床试验注册中心（CTRI）注册，参考编号CTRI/2023/10/059095。
