A clinical guideline-based management of type 2 diabetes by ayurvedic practitioners in Nepal: A feasibility cluster randomized controlled trial protocol.
A clinical guideline-based management of type 2 diabetes by ayurvedic practitioners in Nepal: A feasibility cluster randomized controlled trial protocol.
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DOI：
10.1097/md.0000000000031452
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发表时间：
2022-11-25
期刊：
影响因子：
1.6
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中科院分区：
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2型糖尿病（T2 DM）是一种常见的慢性疾病，具有显著的健康和社会经济后果。在尼泊尔，2型糖尿病是一种常见疾病，人们咨询阿育吠陀（传统医疗系统）医生并使用阿育吠陀药物。阿育吠陀从业者对许多患者的T2 DM管理不佳仍然存在强烈的担忧，因此，基于现有的最佳科学证据，我们制定了阿育吠陀从业者管理T2 DM的临床指南。一项明确的随机分组对照试验（RCT）要解决的研究问题是，与通常的阿育吠陀管理相比，引入临床指南是否可以改善尼泊尔阿育吠陀从业者对T2 DM的管理（即，没有任何临床指南）。为了准备这项未来的工作，目前的研究旨在确定进行明确的集群随机对照试验的可行性。这是一项2组、可行性群组RCT，具有设盲结局评估和定性评价。该研究在尼泊尔加德满都山谷内外的12个公共和私人阿育吠陀中心进行（1：1干预：对照）。合格的参与者应是新的T2 DM成人患者（即，初治）-糖化血红蛋白水平应在6.5%或以上但低于9%。将招募至少120名受试者（60名/组）并随访6个月。将估计设计确定性试验所需的重要参数，如结局指标的标准差（即，6个月随访时的糖化血红蛋白水平）、组内相关系数、聚类大小、招募、招募参与者所需的时间、随访和对推荐的阿育吠陀药物的依从性。将对大约20至30名参与者和所有参与的阿育吠陀从业者进行半结构化定性访谈，以探讨他们参与研究和干预的经验和观点，以及拒绝参与研究的合格人员的样本，以探讨不参与的原因。我们目前正在尼泊尔开展一项可行性分组RCT，以确定开展最终分组试验的可行性。第一名参与者于2022年7月17日招募。如果可行性是有希望的（例如招募，随访和坚持推荐的阿育吠陀药物），那么估计的参数将用于设计最终的群集试验。是否修改方案的决定主要取决于定性数据。
Type 2 diabetes mellitus (T2DM) is a common chronic condition with significant health and socioeconomic consequences. In Nepal, T2DM is a common disease for which people consult ayurvedic (traditional medical system) practitioners and use ayurvedic medicines. Strong concerns remain about the suboptimal T2DM management of many patients by ayurvedic practitioners, and therefore, based on the best available scientific evidence, we have developed a clinical guideline for managing T2DM by ayurvedic practitioners. The research question to be addressed by a definitive cluster randomized controlled trial (RCT) is whether the introduction of a clinical guideline can improve the management of T2DM by ayurvedic practitioners in Nepal as compared to usual ayurvedic management (i.e., without any clinical guideline). In preparation for this future work, this current study aims to determine the feasibility of undertaking the definitive cluster RCT. This is a 2-arm, feasibility cluster RCT with a blinded outcome assessment and a qualitative evaluation. The study is conducted in 12 public and private ayurveda centers in and outside the Kathmandu Valley in Nepal (1:1 intervention:control). Eligible participants should be new T2DM adult patients (i.e., treatment naïve) - the glycated hemoglobin level should be 6.5% or above but less than 9%. At least 120 participants (60/group) will be recruited and followed up for 6 months. Important parameters, needed to design the definitive trial, will be estimated, such as the standard deviation of the outcome measure (i.e., glycated hemoglobin level at 6-month follow-up), intraclass correlation coefficient, cluster size, recruitment, the time needed to recruit participants, follow-up, and adherence to the recommended ayurvedic medicine. Semi-structured qualitative interviews will be conducted with around 20 to 30 participants and all the participating ayurvedic practitioners to explore their experiences and perspectives of taking part in the study and of the intervention and a sample of eligible people declining to participate in the study to explore the reasons behind nonparticipation. We are now conducting a feasibility cluster RCT in Nepal to determine the feasibility of undertaking the definitive cluster trial. The first participant was recruited on 17 July 2022. If the feasibility is promising (such as recruitment, follow-up, and adherence to the recommended ayurvedic medicine), then the parameters estimated will be used to design the definitive cluster trial. Decisions over whether to modify the protocol will mainly be informed by the qualitative data.