Informing a Randomized Control Trial in Rural Populations: Adaptation of a Diabetes Self-Management Education and Support Intervention.

BACKGROUND: Over 34 million people in the United States have diabetes, with 1.5 million diagnosed every year. Diabetes self-management education and support (DSMES) is a crucial component of treatment to delay or prevent complications. Rural communities face many unique challenges in accessing DSMES, including geographic barriers and availability of DSMES programs that are culturally adapted to rural context. OBJECTIVE: Boot Camp Translation (BCT) is an established approach to community-based participatory research used to translate complex clinical and scientific information into concepts, messages, and materials that are understandable, meaningful, and relevant to community members and patients. This study aimed to utilize BCT to adapt an existing DSMES program for delivery in rural primary care for English- and Spanish-speaking people with diabetes. METHODS: The High Plains Research Network (HPRN) Community Advisory Council (C.A.C.) partnered with researchers at the University of Colorado and University of Utah to use BCT to aid in translating medical jargon and materials from an existing DSMES program, called "Diabetes One Day (D1D)." BCT consisted of 10 virtual meetings over a 6-month period among the C.A.C., which included 15 diverse community stakeholders. Both English-speaking and bilingual Spanish-English-speaking C.A.C. members were recruited to reflect the diversity of the rural communities in which the adapted program would be delivered. RESULTS: The BCT process guided adaptations to D1D for use in rural settings (R-D1D). R-D1D adaptations reflect both content and delivery to assure that the intervention is appropriate and likely to be accepted by rural English- and Spanish-speaking people with diabetes. Additionally, BCT informed the design of recruitment and program materials and identification of recruitment venues. During the BCT process, the importance of tailoring materials to reflect culture differences in English- and Spanish-speaking patients was identified. CONCLUSIONS: BCT was an effective strategy for academic researchers to partner with rural community members to adapt an existing DSMES intervention for delivery in rural areas to both English- and Spanish-speaking patients with diabetes. Through BCT, adaptations to recruitment materials and methods, program content and delivery, and supplemental materials were developed. The need to culturally adapt Spanish materials with input from stakeholders rather than simply translate materials into Spanish was highlighted. The importance of increasing awareness of the connection between diabetes and depression or diabetes distress, adaptations to include local foods, and the importance of the relationship between people with diabetes and their primary care practices were identified.

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

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.

Preclinical left ventricular diastolic dysfunction in metabolic syndrome.

Metabolic syndrome (MS) is commonly associated with left ventricular (LV) diastolic dysfunction and LV hypertrophy. We sought to examine whether preclinical LV diastolic dysfunction can occur independent of LV hypertrophy in MS. We recruited 90 consecutive participants with MS and without cardiovascular disease (mean age 46 years, 78% women) and 26 controls (no risk factors for MS; mean age 43 years, 65% women). Participants underwent echocardiography with tissue Doppler imaging. In age- and gender-adjusted analyses, MS was associated with higher left atrial (LA) diameter, higher LV mass, lower E/A ratio, and lower mean e' (p <0.001 for all). These associations remained significant after further adjusting for blood pressure, antihypertensive medication use, and body mass index. After adjusting for LV mass, MS remained independently associated with higher LA diameter, lower E/A ratio, and lower mean e' (p ≤0.01 for all). Specifically, subjects with MS had a 1.8 cm/s lower mean e' compared with controls (p = 0.01). Notably, differences in mean e' between those with and without MS were more pronounced at younger ages (p for interaction = 0.003). In conclusion, MS was associated with preclinical LV diastolic dysfunction independent of LV mass, as reflected by higher LA diameter, lower E/A ratio, and lower mean e'. This suggests that MS can lead to the development of diastolic dysfunction through mechanisms independent of hypertrophy. Differences in diastolic function were more pronounced at younger ages, highlighting the potential importance of early risk factor modification and preventive strategies in MS.