Ensuring fidelity: key elements to consider in disseminating a diabetes telemanagement program for underserved Hispanic/Latinos living with type 2 diabetes.

Background: The Hispanic/Latino population has greater risk (estimated >50%) of developing type 2 diabetes (T2D) and developing it at a younger age. The American Diabetes Association estimates costs of diagnosed diabetes in 2017 was $327 billion; with medical costs 2.3x higher than patients without diabetes. The purpose of this manuscript is to describe the methodology utilized in a randomized controlled trial aimed at evaluating the efficacy of a diabetes telemanagement (DTM) program for Hispanic/Latino patients with T2D. The intent is to provide information for future investigators to ensure that this study can be accurately replicated. Methods: This study was a randomized controlled trial with 240 participants. Eligible patients (Hispanic/Latino, aged 18+, living with T2D) were randomized to Comprehensive Outpatient Management (COM) or DTM. DTM was comprised of usual care, including routine clinic visits every three months, as well as: Biometrics (a tablet, blood glucose meter, blood pressure monitor, and scale); Weekly Video Visits (facilitated in the patient's preferred language); and Educational Videos (including culturally congruent diabetes self-management education and quizzes). COM consisted of usual care including routine clinic visits every three months. For this study, COM patients received a glucometer, glucose test strips, and lancets. Establishing a therapeutic nurse-patient relationship was a fundamental component of our study for both groups. First contact (post-enrollment) centered on ensuring that patients and caregivers understood the program, building trust and rapport, creating a non-judgmental environment, determining language preference, and establishing scheduling availability (including evenings and weekends). DTM were provided with a tablet which allowed for self-paced education through videos and weekly video visits. The research team and Community Advisory Board identified appropriate educational video content, which was incorporated in diabetes educational topics. Video visits allowed us to assess patient involvement, motivation, and nonverbal communication. Communicating in Spanish, and awareness of diverse Hispanic/Latino backgrounds was critical, as using relevant and commonly-used terms can increase adherence and improve outcomes. Shared decision-making was encouraged to make realistic health care choices. Conclusion: Key elements discussed above provide a framework for future dissemination of an evidence-based DTM intervention to meet the needs of underserved Hispanic/Latino people living with T2D.

COVID-19 stressors for Hispanic/Latino patients living with type 2 diabetes: a qualitative study.

Background and aim: During the early stages of the COVID-19 pandemic, nationwide lockdowns caused disruption in the diets, physical activities, and lifestyles of patients with type 2 diabetes. Previous reports on the possible association between race/ethnicity, COVID-19, and mortality have shown that Hispanic/Latino patients with type 2 diabetes who are socioeconomically disadvantaged are disproportionately affected by this novel virus. The aim of this study was to explore stressors associated with changes in diabetes self-management behaviors. Our goal was to highlight the health disparities in these vulnerable racial/ethnic minority communities and underscore the need for effective interventions. Methods and participants: Participants were enrolled in part of a larger randomized controlled trial to compare diabetes telehealth management (DTM) with comprehensive outpatient management (COM) in terms of critical patient-centered outcomes among Hispanic/Latino patients with type 2 diabetes. We conducted a thematic analysis using patient notes collected from two research nurses between March 2020 and March 2021. Two authors read through the transcripts independently to identify overarching themes. Once the themes had been identified, both authors convened to compare themes and ensure that similar themes were identified within the transcripts. Any discrepancies were discussed by the larger study team until a consensus was reached. Results: Six themes emerged, each of which can be categorized as either a source or an outcome of stress. Sources of stress associated with the COVID-19 pandemic were (1) fear of contracting COVID-19, (2) disruptions from lockdowns, and (3) financial stressors (e.g., loss of income). Outcomes of COVID-19 stressors were (1) reduced diabetes management (e.g., reduced diabetes monitoring and physical activity), (2) suboptimal mental health outcomes (e.g., anxiety and depression), and (3) outcomes of financial stressors. Conclusion: The findings indicated that underserved Hispanic/Latino patients with type 2 diabetes encountered a number of stressors that led to the deterioration of diabetes self-management behaviors during the pandemic.

Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study.

BACKGROUND: Home telemonitoring is a promising approach to optimizing outcomes for patients with Type 2 Diabetes; however, this care strategy has not been adapted for use with understudied and underserved Hispanic/Latinos (H/L) patients with Type 2 Diabetes. METHODS: A formative, Community-Based Participatory Research approach was used to adapt a home telemonitoring intervention to facilitate acceptability and feasibility for vulnerable H/L patients. Utilizing the ADAPT-ITT framework, key stakeholders were engaged over an 8-month iterative process using a combination of strategies, including focus groups and structured interviews. Nine Community Advisory Board, Patient Advisory, and Provider Panel Committee focus group discussions were conducted, in English and Spanish, to garner stakeholder input before intervention implementation. Focus groups and structured interviews were also conducted with 12 patients enrolled in a 1-month pilot study, to obtain feedback from patients in the home to further adapt the intervention. Focus groups and structured interviews were approximately 2 hours and 30 min, respectively. All focus groups and structured interviews were audio-recorded and professionally transcribed. Structural coding was used to mark responses to topical questions in the moderator and interview guides. RESULTS: Two major themes emerged from qualitative analyses of Community Advisory Board/subcommittee focus group data. The first major theme involved intervention components to maximize acceptance/usability. Subthemes included tablet screens (e.g., privacy/identity concerns; enlarging font sizes; lighter tablet to facilitate portability); cultural incongruence (e.g., language translation/literacy, foods, actors "who look like me"); nursing staff (e.g., ensuring accessibility; appointment flexibility); and, educational videos (e.g., the importance of information repetition). A second major theme involved suggested changes to the randomized control trial study structure to maximize participation, including a major restructuring of the consenting process and changes designed to optimize recruitment strategies. Themes from pilot participant focus group/structured interviews were similar to those of the Community Advisory Board such as the need to address and simplify a burdensome consenting process, the importance of assuring privacy, and an accessible, culturally congruent nurse. CONCLUSIONS: These findings identify important adaptation recommendations from the stakeholder and potential user perspective that should be considered when implementing home telemonitoring for underserved patients with Type 2 Diabetes. TRIAL REGISTRATION: NCT03960424; ClinicalTrials.gov (US National Institutes of Health). Registered 23 May 2019. Registered prior to data collection. https://www.clinicaltrials.gov/ct2/show/NCT03960424?term=NCT03960424&draw=2&rank=1.

CXCR2 Inhibition - a novel approach to treating CoronAry heart DiseAse (CICADA): study protocol for a randomised controlled trial.

BACKGROUND: There is emerging evidence of the central role of neutrophils in both atherosclerotic plaque formation and rupture. Patients with lower neutrophil counts following acute coronary syndromes tend to have a greater coronary flow reserve, which is a strong predictor of long-term cardiovascular health. But so far, no data are available regarding the impact of neutrophil inhibition on cardiovascular clinical or surrogate endpoints. Therefore, the aim of this study is to investigate the effects of AZD5069, a cysteine-X-cysteine chemokine receptor 2 (CXCR2) inhibitor, on coronary flow reserve and coronary structure and function in patients with coronary artery disease. METHODS/DESIGN: Ninety subjects with coronary artery disease undergoing percutaneous coronary intervention will be included in this investigator-driven, randomised, placebo-controlled, double-blind, phase IIa, single-centre study. Participants will be randomised to receive either AZD5069 (40 mg) administered orally twice daily or placebo for 24 weeks. Change in coronary flow reserve as determined by 13N-ammonia positron emission tomography-computed tomography will be the primary outcome. Change in the inflammatory component of coronary plaque structure and the backward expansion wave, an invasive coronary physiological measure of diastolic function, will be assessed as secondary outcomes. DISCUSSION: Cardiovascular surrogate parameters, such as coronary flow reserve, may provide insights into the potential mechanisms of the cardiovascular effects of CXCR2 inhibitors. Currently, ongoing trials do not specifically focus on neutrophil function as a target of intervention, and we therefore believe that our study will contribute to a better understanding of the role of neutrophil-mediated inflammation in coronary artery disease. TRIAL REGISTRATION: EudraCT, 2016-000775-24 . Registered on 22 July 2016. International Standard Randomised Controlled Trial Number, ISRCTN48328178 . Registered on 25 February 2016.