BACKGROUND
Diabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES,1 yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities.
OBJECTIVE
The specific aims are: 1) adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D) and 2) Conduct a patient-level randomized control trial to examine effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
METHODS
This is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at two rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the RE-AIM framework. Patient-level effectiveness outcomes (A1c, diabetes distress and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice- and patient-level acceptability and feasibility will be assessed using surveys and interviews.
RESULTS
This study is supported by the National Institute of Nursing. Study procedures were approved, and adaptation processes have been completed. Recruitment and enrollment started in July 2021.
CONCLUSIONS
To our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited.
CLINICALTRIAL
ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622
R-D1D – A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Control Trial (Preprint)