JMIR Publications

ABSTRACT

Background:

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

Objective:

To describe a pilot study protocol that evaluates the SMart-D intervention feasibility, acceptability, and effectiveness with intentions to scale up the intervention in the future. This mixed-method study incorporates the RE-AIM framework to evaluate reach, effectiveness, adoption, implementation, and maintenance of 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 and are receiving healthcare 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 over 12 weeks. Focus groups/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 9.4.

Results:

We hypothesize that (a) at least 50% of eligible clinics and 50% of eligible patients who are invited will participate, and at least 75% of patients will complete the program; (b) patients who receive the intervention will have improved self-care behaviors and clinical test results with at least 75% of the patients will maintain improved outcomes at follow-up visits compared with baseline, and participants will verbalize that the intervention is feasible and acceptable. As of April 2023, we enrolled 10 clinics and 34 patients. Baseline data results will be available by end of 2023 and outcomes data will be published in 2025.

Conclusions:

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