A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial

Abstract

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 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 of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance 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 2 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 Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A1c, diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews. Results This study is supported by the National Institute of Nursing. The study procedures were approved, and the 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. Trial Registration ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622 International Registered Report Identifier (IRRID) DERR1-10.2196/34255

Diabetes Self-management Education and Support Completion Before and During the COVID-19 Pandemic: Results From Local Health Departments in North Carolina

“…Currently, there is an ongoing clinical trialthe Diabetes One-Day (D1D) intervention, which is a condensed, 1-day group DSMES session delivered via telehealth by a multidisciplinary team at a diabetes and endocrinology center. 16 Their findings could be very informative.…”

“…Studies are needed to evaluate outcomes of different delivery models, such as improved self-care behaviors, reduced weight, and better glycated hemoglobin A 1c (HbA 1c ). Currently, there is an ongoing clinical trial—the Diabetes One-Day (D1D) intervention, which is a condensed, 1-day group DSMES session delivered via telehealth by a multidisciplinary team at a diabetes and endocrinology center 16. Their findings could be very informative.…”

Challenges and Opportunities for Diabetes Care in Indigenous People: A Scoping Review

“…An example of intervention is diabetes self-management-based telehealth. This program is adapted to conduct diabetes care, specifically for indigenous people (62). The databased diabetes self-management education and support (DSMES) intervention is culturally adapted to rural cities of the Mayan Tribe in Guatemala (63).…”

“…Intervention Modification Based on Culture, Language, and Technology Some modified interventions that consider the needs and backgrounds (culture, beliefs, and language) of indigenous people provide significant results and effective care for their diabetes (62,63). In addition, to solve the problems of high costs and difficult service access gaps in diabetes care, indigenous people can employ technology-based modified interventions (32,33).…”