Road to Hierarchical Diabetes Management at Primary Care (ROADMAP) Study in China: Protocol for the Statistical Analysis of a Cluster Randomized Controlled Trial
- Resource Type
- article
- Authors
- Li, Xian; Duolikun, Nadila; Cheng, Fengzhuo; Billot, Laurent; Jia, Weiping; Zhang, Puhong
- Source
- JMIR Research Protocols, Vol 9, Iss 4, p e18333 (2020)
- Subject
- Medicine
Computer applications to medicine. Medical informatics
R858-859.7
- Language
- English
- ISSN
- 1929-0748
BackgroundAs the management of type 2 diabetes remains suboptimal in primary care, the Road to Hierarchical Diabetes Management at Primary Care (ROADMAP) study was designed and conducted in diverse primary care settings to test the effectiveness of a three-tiered diabetes management model of care in China. ObjectiveThis paper aims to predetermine the detailed analytical methods for the ROADMAP study before the database lock to reduce potential bias and facilitate transparent analyses. MethodsThe ROADMAP study adopts a community-based, cluster randomized controlled trial design that compares the effectiveness of a tiered diabetes management model on diabetes control with usual care among patients with diabetes over a 1-year study period. The primary outcome is the control rate of glycated hemoglobin (HbA1c)