Effects of community family doctors-led intervention for self-management and medication adherence in type 2 diabetes mellitus patients: study protocol of a cluster randomised controlled trial

INTRODUCTION: The management of diabetes has become a critical public health issue in China. The development of community-based type 2 diabetes management in China has not yet reached an ideal state, and the most suitable management methods for diabetic patients are still being explored. Few studies have used community-based family doctors to perform interventions of appropriate intensity. This protocol describes a planned randomised controlled trial to evaluate the effectiveness of a family doctor-led intervention model for diabetes self-management and medication adherence in type 2 diabetes mellitus patients. METHODS AND ANALYSIS: This is a Standard Protocol Items: Recommendations for Interventional Trials-compliant cluster randomised controlled trial. The study will be conducted at four CHCs (community health centers). The control group will receive conventional medical services and health education. The intervention group will receive an intervention led by community family doctors based on the conventional medical services and health education. It will include five parts: usual care, a medication reminder, a 4-week plan, a weekly phone interview and a monthly interview. The primary outcomes are changes in fasting blood glucose, glycosylated haemoglobin, self-management knowledge and behaviour, and medication adherence from baseline to the 3rd and 6th months. The secondary outcome is the proportion of people whose blood sugar and glycosylated haemoglobin are under control in the 3rd and 6th months. ETHICS AND DISSEMINATION: The study proposal was approved by the Biomedical Ethics Committee of the Medical Department of Xi’an Jiaotong University (no. 2021-1371). The findings will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR2100051685.