mHealth Intervention for Vietnamese Living With Diabetes: Protocol for a Stepped Wedge Pilot Study
Authors: Nguyen Anna , Nagykaldi Zsolt , Bui Thanh , Chen Sixia , Businelle Michael , Eschiti Valerie , Dwyer Kathleen 
Published: August 2023

Background
Evidence indicates participation in a diabetes self-management education and support program improves self-care behaviors and hemoglobin A1c. Language and cultural differences may be barriers to program participation resulting in ineffective self-management, but these factors can be addressed with appropriate interventions. Given the high health care costs associated with diabetes complications, we developed a multicomponent, culturally tailored Self-Management Mobile Health Intervention for US Vietnamese With Diabetes (SMart-D).

Objective
This study aims to evaluate the SMart-D intervention’s feasibility, acceptability, and effectiveness with intentions to scale up the intervention in the future. This mixed methods study incorporates the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate the intervention.

Methods
This stepped wedge randomized controlled pilot study will be conducted over 2 years in collaboration with primary care clinics. Eligible participants are patients with type 2 diabetes who are receiving health care from participating clinics. Clinics will be randomly assigned to an implementation date and will begin with patients enrolling in the control period while receiving standard care, then cross over to the intervention period where patients receive standard care plus the SMart-D intervention for over 12 weeks. Focus groups or interviews will be conducted with clinicians and patients after study completion. Qualitative data will be analyzed using NVivo. Outcomes on self-care behavior changes will be measured with the Summary of Diabetes Self-Care Activities scale and clinical changes will be measured using laboratory tests. A generalized linear mixed-effect model will be used to compute time effect, clustering effect, and the interaction of the control and intervention periods using SAS (version 9.4; SAS Institute).

Results
We hypothesize that (1) at least 50% (n=5) of eligible clinics and 50% (n=40) of eligible patients who are invited will participate, and at least 70% (n=56) of patients will complete the program, and (2) patients who receive the intervention will have improved self-care behaviors and clinical test results with at least 75% (n=60) of the patients maintaining improved outcomes at follow-up visits compared with baseline, and participants will verbalize that the intervention is feasible and acceptable. As of August 2023, we enrolled 10 clinics and 60 patients. Baseline data results will be available by the end of 2023 and outcome data will be published in 2025.

Conclusions
This is the first Vietnamese diabetes self-management education and support intervention that leverages mobile health technology to address the barriers of language and culture differences through collaboration with primary care clinics. This study will provide a better understanding of the implementation process, demonstrate the potential effectiveness of the intervention, accelerate the pace of moving evidence-based interventions to practice among the US Vietnamese population, and potentially provide a replicable implementation model that can be culturally adapted to other non-English speaking ethnic minorities.

International Registered Report Identifier (IRRID)
DERR1-10.2196/48585