Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal (NUCOD): Study Protocol for a Cluster Randomized Controlled Trial
The study aims 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.
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.
We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a
NUrse-led COntinuum of care for people with diabetes and pre-diabetes (NUCOD), with primary
care centers (Outreach centers and 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 pre-diabetes, 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.
The results of this trial will provide information about the effectiveness of the NUCOD
program in improving clinical outcomes for diabetes and pre-diabetes individuals, and
implementation outcomes for the organization.
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