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Published in: Trials 1/2020

Open Access 01-12-2020 | Care | Study protocol

NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial

Authors: Dong ( Roman) Xu, Rubee Dev, Abha Shrestha, Lingling Zhang, Archana Shrestha, Pushpanjali Shakya, James P. Hughes, Prabin Raj Shakya, Jinghua Li, Jing Liao, Biraj Man Karmacharya

Published in: Trials | Issue 1/2020

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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 a standard diabetes program in Nepal.

Methods

We 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.

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. 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 registration

ClinicalTrials.gov, NCT04131257. Registered on 18 October 2019.
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Metadata
Title
NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial
Authors
Dong ( Roman) Xu
Rubee Dev
Abha Shrestha
Lingling Zhang
Archana Shrestha
Pushpanjali Shakya
James P. Hughes
Prabin Raj Shakya
Jinghua Li
Jing Liao
Biraj Man Karmacharya
Publication date
01-12-2020
Publisher
BioMed Central
Keywords
Care
Prediabetes
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04372-5

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