Abstract
BackgroundThe 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 a standard diabetes program in Nepal.MethodsWe will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of the NUrse-led COntinuum of care for people with Diabetes (N1 = 200) and prediabetes (N2 = 1036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts) as a unit of randomization. The NUCOD program will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared with the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be the change in glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, 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.DiscussionThe 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. The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context.Trial registrationClinicalTrials.gov, NCT04131257. Registered on 18 October 2019.
Highlights
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 utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal
The primary objective of this study is to examine the effectiveness of this comprehensive intervention in promoting the health of the people with diabetes and prediabetes, and the secondary objective is to examine whether the nurse coordination will promote the implementation of the evidence-based, Disease Control Priority-3 (DCP-3)-recommended interventions
We will select and train standardized patients (SPs) from the program participants with stable conditions—these SPs will serve as the “secret agents” and the sentry to assess program fidelity with a quality checklist through their routine encounters with the clinicians at the Dhulikhel Hospital (DH) diabetes clinic and the nurses; the clinicians will be blinded to the status of the SPs; and the development of SPs and the checklist will follow the protocol we have developed in a separate study [34]
Summary
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 utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal. The most recently published Disease Control Priority-3 (DCP-3) systematically reviewed available interventions for diabetes in resource-limited settings, and strongly recommended the following interventions based on their cost-effectiveness and feasibility: targeted (two-step) screening for both prediabetes and diabetes; blood pressure control among people with diabetes; lifestyle interventions to prevent diabetes among high-risk individuals; and good glycemic control along with smoking cessation and foot care. The DCP-3 pointed out two knowledge gaps: little evidence for the testing of the effectiveness of those interventions in lowincome settings; and a lack of implementation-oriented research for adopting and scaling up those interventions This is compounded by the fact that a chronic disease like diabetes needs a structured, well-concerted comprehensive approach comprising continuum of care prevention activities, timely screening, standard clinical management and self-management skills for lifestyle modification rather than segregated interventions.
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