Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial.
Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial.
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DOI：
10.1186/s13063-023-07243-x
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发表时间：
2023-03-23
期刊：
影响因子：
2.5
通讯作者：
Fottrell, Edward
中科院分区：
文献类型：
--
作者：
King, Carina;Pires, Malini;Ahmed, Naveed;Akter, Kohenour;Kuddus, Abdul;Copas, Andrew;Haghparast-Bidgoli, Hassan;Morrison, Joanna;Nahar, Tasmin;Shaha, Sanjit Kumer;Khan, AKAzad;Azad, Kishwar;Fottrell, Edward
关键词：
“糖尿病：社区主导的意识、反应和评估”(D：CLARE)试验旨在扩大和复制孟加拉国基于证据的参与性学习和行动周期干预，为人群水平的T2 DM预防和控制政策提供信息。该试验最初设计为阶梯式楔形群随机对照试验，干预措施从2020年3月持续到2022年9月。12个组被随机分配(1：1)，在1或12个月分两步实施干预，并在1、12和24个月通过三次横断面调查进行评估。但是，由于新冠肺炎疫情，我们在2020年3月20日暂停了项目活动。由于风险格局的变化和新冠肺炎大流行带来的延迟，我们从阶梯楔形设计改为具有基线数据的等待名单并行ARM群集随机对照试验(CRCT)。我们最终同意改变设计有四个关键原因：均衡、曝光和结果的时间偏差、权力和时间的损失以及资金方面的考虑。试用登记ISRCTN42219712。注册日期为2019年10月31日。
The “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs: equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations. Trial registration ISRCTN42219712. Registered on 31 October 2019.
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作者：
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