Lifespan and Population Health Academic Unit, School of Medicine, University of Nottingham, Nottingham, UK.
The Nottingham Centre for Evidence-Based Healthcare: A JBI Centre of Excellence, Nottingham, UK.
Medicine (Baltimore). 2022 Nov 25;101(47):e31452. doi: 10.1097/MD.0000000000031452.
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.
2 型糖尿病（T2DM）是一种常见的慢性疾病，对健康和社会经济都有重大影响。在尼泊尔，T2DM 是一种常见病，人们会咨询阿育吠陀（传统医疗体系）从业者并使用阿育吠陀药物。人们对阿育吠陀从业者对许多患者的 T2DM 管理效果不佳仍存在强烈担忧，因此，我们根据现有最佳科学证据，为阿育吠陀从业者制定了 T2DM 管理临床指南。一项明确的整群随机对照试验（RCT）要解决的研究问题是，与常规阿育吠陀管理（即没有任何临床指南）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 T2DM 的管理。为了准备这项未来的工作，本研究旨在确定开展明确的整群 RCT 的可行性。
这是一项 2 臂、可行性整群 RCT，采用盲法结局评估和定性评估。该研究在尼泊尔加德满都谷地内外的 12 家公立和私立阿育吠陀中心进行（1:1 干预：对照）。合格的参与者应为新的 T2DM 成年患者（即治疗初治）-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 名参与者（每组 60 名），并随访 6 个月。将估计一些重要参数，以设计明确的试验，例如结局测量（即 6 个月随访时的糖化血红蛋白水平）的标准差、组内相关系数、群集大小、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 20-30 名参与者和所有参与的阿育吠陀从业者进行半结构式定性访谈，以探讨他们参与研究的经验和观点，以及对推荐的阿育吠陀药物的干预和拒绝参与研究的合格人员的原因进行探讨。
我们目前正在尼泊尔进行一项可行性整群 RCT，以确定开展明确的整群 RCT 的可行性。第一名参与者于 2022 年 7 月 17 日招募。如果可行性较好（如招募、随访和对推荐的阿育吠陀药物的依从性），则将使用估计的参数来设计明确的整群 RCT。是否修改方案的决定主要将根据定性数据做出。
