NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial
Open Access
- 29 May 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 21 (1), 1-12
- https://doi.org/10.1186/s13063-020-04372-5
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 (N-1=200) and prediabetes (N-2=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 12months 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.Other Versions
This publication has 33 references indexed in Scilit:
- The RE-AIM Framework: A Systematic Review of Use Over TimeAmerican Journal of Public Health, 2013
- Prediabetes: a high-risk state for diabetes developmentThe Lancet, 2012
- The consequences of complacency: managing the effects of unrecognized Charcot feetDiabetic Medicine, 2011
- Adapting the Diabetes Prevention Program Lifestyle Intervention for Delivery in the CommunityThe Diabetes Educator, 2007
- Multiple behavioral risk factor interventions in primary care: Summary of research evidenceAmerican Journal of Preventive Medicine, 2004
- CONSORT statement: extension to cluster randomised trialsBMJ, 2004
- Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood PressureHypertension, 2003
- The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood PressureThe JNC 7 ReportJAMA, 2003
- The summary of diabetes self-care activities measure: results from 7 studies and a revised scale.Diabetes Care, 2000
- Nurse Case Management To Improve Glycemic Control in Diabetic Patients in a Health Maintenance OrganizationAnnals of Internal Medicine, 1998