Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial.
Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial.
复制标题
DOI：
10.1186/s13063-021-05167-y
复制
发表时间：
2021-03-29
期刊：
影响因子：
2.5
通讯作者：
Fottrell E
中科院分区：
文献类型：
--
作者：
King C;Pires M;Ahmed N;Akter K;Kuddus A;Copas A;Haghparast-Bidgoli H;Morrison J;Nahar T;Shaha SK;Khan AKA;Azad K;Fottrell E
全球估计有4.63亿人患有糖尿病，在孟加拉国等低收入和中等收入环境中患病率不断上升。鉴于需要针对具体情况采取干预措施来预防2型糖尿病（T2DM），“糖尿病：社区主导的意识、反应和评估”（D:Clare）试验将严格评估孟加拉国参与式学习和行动（PLA）循环干预的复制和推广情况，为人口层面的T2DM预防和控制政策提供信息。这是一项阶梯形随机对照试验，综合了过程和经济评估，于2020年3月至2022年9月进行。该试验将评估以社区为基础的四阶段PLA周期干预，重点是预防和控制2型糖尿病，实施时间超过18个月，对照常规护理的控制。12个小组将随机分配（1:1）在项目第1个月或第12个月实施干预。干预措施将在第1、12和24个月通过三次横断面调查进行评估。该试验将在Faridpur地区的Alfadanga Upazila进行，该地区估计有12万人口。集群被定义为人口大致相等的行政地理区域。阿尔法丹加地区的6个工会将分成2个团体，共12个团体。考虑到集群间污染的风险，评估调查将排除边境地区的村庄。参与者将从2020年1月进行的人口普查中随机抽取，每次调查都是独立的。主要终点是通过空腹和2小时后血糖负荷血液测试测量的中度高血糖和T2DM的联合患病率。假设基线为30%，ICC为0.07，总共4680名参与者提供了84%的能力来检测主要结果减少30%。分析将通过意向治疗，比较所有集群的干预和控制期，并根据地理集群进行调整。本研究将提供进一步的证据，证明在孟加拉国农村地区，以社区为基础的PLA预防T2DM的有效性。然而，在将楔形设计应用于我们的研究背景时，我们遇到了一些挑战，特别是要考虑平衡季节性、时间和步骤数量，以及部分效果与完全效果的估计。ISRCTN: ISRCTN42219712。于2019年10月31日注册
An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the ‘Diabetes: Community-led Awareness, Response and Evaluation’ (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. ISRCTN: ISRCTN42219712. Registered on 31 October 2019
登录
查看更多内容
DOI：
10.1136/bmj.h1258
发表时间：
2015-03-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moore GF;Audrey S;Barker M;Bond L;Bonell C;Hardeman W;Moore L;O'Cathain A;Tinati T;Wight D;Baird J
通讯作者：
Baird J
影响因子：
3.1
作者：
CAREY, MP;JORGENSEN, RS;MEISLER, AW
通讯作者：
MEISLER, AW
影响因子：
1.6
作者：
Khetan, Aditya;Patel, Toral;Webel, Allison
通讯作者：
Webel, Allison
影响因子：
15.8
作者：
Thankappan, Kavumpurathu R.;Sathish, Thirunavukkarasu;Oldenburg, Brian
通讯作者：
Oldenburg, Brian
影响因子：
2.8
作者：
Kul, Seval;Savas, Esen;Karadag, Gulendam
通讯作者：
Karadag, Gulendam