Nurse-led continuum of care for people with diabetes and pre-diabetes in Nepal (NUCOD): study protocol for a cluster randomized controlled trial

Abstract Background: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal. Methods: We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NU rse-led CO ntinuum of care for people with D iabetes (N1=200) and pre-diabetes (N2=1036) (NUCOD) , with primary care centers (9 Outreach Centers and 17 Government Health Posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among prediabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis. Discussion: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. Trial registration: This study was registered in a clinical trials registry via ClinicalTrials.gov (NCT04131257) on 18 October 2019. https://bit.ly/34qwIAd