Design and rationale of the cardiometabolic health program linked with community health workers and mobile health telemonitoring to reduce health disparities (LINKED-HEARTS) program.

BACKGROUND: Hypertension and diabetes are major risk factors for cardiovascular diseases, stroke, and chronic kidney disease (CKD). Disparities in hypertension control persist among Black and Hispanic adults and persons living in poverty in the United States. The "LINKED-HEARTS Program" (a Cardiometabolic Health Program LINKED with Community Health WorkErs and Mobile HeAlth TelemonitoRing To reduce Health DisparitieS"), is a multi-level intervention that includes home blood pressure (BP) monitoring (HBPM), blood glucose telemonitoring, and team-based care. This study aims to examine the effect of the LINKED-HEARTS Program intervention in improving BP control compared to enhanced usual care (EUC) and to evaluate the reach, adoption, sustainability, and cost-effectiveness of the program. METHODS: Using a hybrid type I effectiveness-implementation design, 428 adults with uncontrolled hypertension (systolic BP ≥ 140 mm Hg) and diabetes or CKD will be recruited from 18 primary care practices, including community health centers, in Maryland. Using a cluster-randomized trial design, practices are randomly assigned to the LINKED-HEARTS intervention arm or EUC arm. Participants in the LINKED-HEARTS intervention arm receive training on HBPM, BP and glucose telemonitoring, and community health worker and pharmacist telehealth visits on lifestyle modification and medication management over 12 months. The primary outcome is the proportion of participants with controlled BP (<140/90 mm Hg) at 12 months. CONCLUSIONS: The study tests a multi-level intervention to control multiple chronic diseases. Findings from the study may be leveraged to reduce disparities in the management and control of chronic diseases and make primary care more responsive to the needs of underserved populations. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05321368.

Design and Rationale of the Social Determinants of the Risk of Hypertension in Women of Reproductive Age (SAFE HEART) Study: An American Heart Association Research Goes Red Initiative.

BACKGROUND: Cardiovascular health literacy (CVHL) and social determinants of health (SDoH) play interconnected and critical roles in shaping cardiovascular health (CVH) outcomes. However, awareness of CVH risk has declined markedly, from 65% of women being aware that cardiovascular disease (CVD) is the leading cause of death for women in 2009 to just 44% being aware in 2019. The American Heart Association Research Goes Red (RGR) initiative seeks to develop an open-source, longitudinal, dynamic registry that will help women to be aware of and participate in research studies, and to learn about CVD prevention. We proposed to leverage this platform, particularly among Black and Hispanic women of reproductive age, to address CVHL gaps and advance health equity. METHODS: The primary objective of the study is to evaluate the cross-sectional association of cardiovascular health literacy (CVHL), SDoH using a polysocial score, and CVH in women of reproductive age at increased risk of developing hypertension (HTN). To achieve this we will use a cross-sectional study design, that engages women already enrolled in the RGR registry (registry-enrolled). To enhance the racial and ethnic/social economic diversity of the cohort, we will additionally enroll 300 women from the Baltimore and Washington D.C. community into the Social Determinants of the Risk of Hypertension in Women of Reproductive Age (SAFE HEART) Study. Community-enrolled and registry-enrolled women will undergo baseline social phenotyping including detailed SDoH questionnaire, CVH metrics assessment, and CVHL assessment. The secondary objective is to assess whether a 4-month active health education intervention will result in a change in CVHL in the 300 community-enrolled women. DISCUSSION: The SAFE HEART study examines the association between CVHL, SDoH, and CVH, with a focus on racial and ethnic minority groups and socioeconomically disadvantaged women of reproductive age, and the ability to improve these parameters by an educational intervention. These findings will inform the future development of community-engaged strategies that address CVHL and SDoH among women of reproductive age.

Improving mental health in black men through a 24-week community-based lifestyle change intervention: the black impact program.

BACKGROUND: Poor mental health is a leading cause of morbidity and mortality among Black men in the United States. Efforts to improve mental health among Black men have been hampered by a lack of access and utilization of mental health services. Physical activity and social networks have been shown to improve mental health. Thus, we examined the effect of a community team-based physical activity, health education and social needs intervention among Black men on mental health over 24 weeks. METHODS: Black adult males (n = 74) from a large Midwestern city participated in Black Impact, a 24-week community-based lifestyle change program adapted from the Diabetes Prevention Program and American Heart Association's (AHA) Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA's Life's Simple 7 (LS7) framework. Measures of mental health including the Center for Epidemiological Studies Depression Scale (CES-D), Patient Health Questionnaire 2-question depression screener (PHQ-2), and Perceived Stress Scale-10 (PSS-10) were completed at baseline, 12 and 24 weeks. The change in mental health scores from baseline to 12 and 24 weeks were evaluated using linear mixed-effects models adjusting for age, education, and income. The change in cardiovascular health scores, defined as objective metrics of LS7 (LS5 [blood pressure, total cholesterol, fasting glucose, body mass index and smoking]), by baseline mental health were evaluated using linear mixed-effects models with an interaction term (time*baseline mental health variable) and a random intercept for each participant. RESULTS: Among 71 Black men (mean age 51, 85% employed) at 24 weeks, CES-D scores decreased from 10.54 to 7.90 (-2.64, 95%CI:-4.74, -0.55), PHQ-2 decreased from 1.04 to 0.63 (-0.41, 95%CI: -0.75, -0.07), and PSS-10 decreased from 14.62 to 12.91 (-1.71, 95%CI: -3.53, 0.12). A 1-unit higher CES-D at baseline was associated with less improvement in LS5 scores by -0.04 (95%CI: -0.076, -0.005) and - 0.032 (95%CI:-0.067, 0.003) units at week 12 and 24, respectively, with similar findings for PSS. CONCLUSIONS: The Black Impact community-based lifestyle program has the potential to reduce depressive symptoms and stress in Black men. There is a dire need for larger, randomized studies to test the impact of Black Impact on mental health in Black men to advance health equity. TRIAL REGISTRATION: Retrospectively Registered, ClinicalTrials.gov Identifier: NCT04787978.

Community-Based Interventions to Address Disparities in Cardiometabolic Diseases Among Minoritized Racial and Ethnic Groups.

PURPOSE OF REVIEW: Cardiometabolic diseases (CMDs) are leading causes of death and disproportionally impact historically marginalized racial/ethnic groups in the United States. The American Heart Association developed the Life's Essential 8 (LE8) to promote optimal cardiovascular health (CVH) through eight health behaviors and health factors. The purpose of this review is to summarize contemporary community-engaged research (CER) studies incorporating the LE8 framework among racial/ethnic groups. REVIEW OF FINDINGS: Limited studies focused on the interface of CER and LE8. Based on synthesis of articles in this review, the application of CER to individual/collective LE8 metrics may improve CVH and reduce CMDs at the population level. Effective strategies include integration of technology, group activities, cultural/faith-based practices, social support, and structural/environmental changes. CER studies addressing LE8 factors in racial/ethnic groups play an essential role in improving CVH. Future studies should focus on broader scalability and health policy interventions to advance health equity.

Leveraging community Wi-Fi and spaces for digital health use.

Digital health disparities continue to affect marginalized populations, especially older adults, individuals with low-income, and racial/ethnic minorities, intensifying the challenges these populations face in accessing healthcare. Bridging this digital divide is essential, as digital access and literacy are social determinants of health that can impact digital health use and access to care. This article discusses the potential of leveraging community Wi-Fi and spaces to improve digital access and digital health use, as well as the challenges and opportunities associated with this strategy. The existing limited evidence has shown the possibility of using community Wi-Fi and spaces, such as public libraries, to facilitate telehealth services. However, privacy and security issues from using public Wi-Fi and spaces remain a concern for librarians and healthcare professionals. To advance digital equity, efforts from multilevel stakeholders to improve users' digital access and literacy and offer tailored technology support in the community are required. Ultimately, leveraging community Wi-Fi and spaces offers a promising avenue to expand digital health accessibility and use, highlighting the critical role of collaborative efforts in overcoming digital health disparities.

Impact of Social Determinants of Health on Hypertension Outcomes: A Systematic Review.

Despite ample evidence linking social determinants of health (SDoH) and hypertension outcomes, efforts to address SDoH in the context of hypertension prevention and self-management are not commensurate with the burden and impact of hypertension. To provide valuable insights into the development of targeted and effective strategies for preventing and managing hypertension, this systematic review, guided by the Healthy People 2030 SDoH framework, aims to summarize the inclusion, measurement, and evaluation of SDoH in studies examining hypertension outcomes, with a focus on characterizing SDoH constructs and summarizing the current evidence of their influence on hypertension outcomes. Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive search of electronic databases identified 10 608 unique records, from which 57 articles meeting inclusion criteria were analyzed. The studies, conducted nationally or regionally across the United States, revealed that higher educational attainment, health insurance coverage, income, and favorable neighborhood characteristics were associated with lower hypertension prevalence and better hypertension control among US adults. The findings underscore the importance of addressing SDoH such as education, health care access, economic stability, neighborhood environments, and social context to reduce hypertension disparities. Multilevel collaboration and community-engaged practices are necessary to tackle these disparities effectively.

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities.

BACKGROUND: Black Americans remain significantly underrepresented and understudied in research. Community-based interventions have been increasingly recognized as an effective model for reckoning with clinical trial participation challenges amongst underrepresented groups, yet a paucity of studies implement this approach. The present study sought to gain insight into Black male participants' perception of clinical trials before and after participating in a community-based team lifestyle intervention in the United States. METHODS: Black Impact, a 24-week community-based lifestyle intervention, applied the American Heart Association's Life's Simple 7 (LS7) framework to assess changes in the cardiovascular health of seventy-four Black male participants partaking in weekly team-based physical activities and LS7-themed education and having their social needs addressed. A subset of twenty participants completed an exit survey via one of three semi-structured focus groups aimed at understanding the feasibility of interventions, including their perceptions of participating in clinical trials. Data were transcribed verbatim and analyzed using a content analysis, which involved systematically identifying, coding, categorizing, and interpreting the primary patterns of the data. RESULTS: The participants reported a positive change in their perceptions of clinical trials based on their experience with a community-based lifestyle intervention. Three prominent themes regarding their perceptions of clinical trials prior to the intervention were as follows: (1) History of medical abuse; (2) Lack of diversity amongst research teams and participants; and (3) A positive experience with racially concordant research teams. Three themes noted to influence changes in their perception of clinical trials based on their participation in Black Impact were as follows: (1) Building trust with the research team; (2) Increasing awareness about clinical trials; and (3) Motivating participation through community engagement efforts. CONCLUSIONS: Improved perceptions of participating in clinical trials were achieved after participation in a community-based intervention. This intervention may provide a framework by which to facilitate clinical trial participation among Black men, which must be made a priority so that Black men are "more than just a number" and no longer "receiving the short end of the stick".

Cardiovascular Risk Profile Among Reproductive-Aged Women in the U.S.: The Behavioral Risk Factor Surveillance System, 2015-2020.

Introduction: Suboptimal cardiovascular health is associated with adverse pregnancy outcomes and long-term cardiovascular risk. The authors examined trends in cardiovascular risk factors and correlates of suboptimal cardiovascular risk profiles among reproductive-aged U.S. women. Methods: With data from 335,959 women in the Behavioral Risk Factor Surveillance System (2015-2020), the authors conducted serial cross-sectional analysis among nonpregnant reproductive-aged women (18-44 years) without cardiovascular disease who self-reported information on 8 cardiovascular risk factors selected on the basis of Life's Essential 8 metrics. The authors estimated the prevalence of each risk factor and suboptimal cardiovascular risk profile (≥2 risk factors) and examined trends overall and by age and race/ethnicity. Using multivariable Poisson regression, the authors assessed the sociodemographic correlates of suboptimal cardiovascular risk profile. Results: The weighted prevalence of women aged <35 years was approximately 64% in each survey year. The prevalence of suboptimal cardiovascular risk profile increased modestly from 72.4% (71.6%-73.3%) in 2015 to 75.9% (75.0%-76.7%) in 2019 (p<0.001). This increase was mainly driven by increases in overweight/obesity (53.1%-58.4%; p<0.001). Between 2015 and 2019, significant increases in suboptimal cardiovascular risk profile were observed among non-Hispanic White (69.8%-72.6%; p<0.001) and Hispanic (75.1%-80.3%; p<0.001) women but not among non-Hispanic Black (82.7%-83.7%; p=0.48) or Asian (68.1%-73.2%; p=0.09) women. Older age, rural residence, and non-Hispanic Black and Hispanic race and ethnicity were associated with a higher prevalence of suboptimal cardiovascular risk profile. Conclusions: There has been a modest but significant increase in suboptimal cardiovascular risk profile among U.S. women of reproductive age. Urgent preventive efforts are needed to reverse this trend and improve cardiovascular health, particularly among subgroups at increased risk, to mitigate its implications.

Virtual Community Engagement for Retention of Black Men in Clinical Research.

Black American men have worse cardiovascular health compared with their White counterparts, yet are highly underrepresented in clinical trials. In 2020, Black men were recruited to participate in Black Impact, a community-based lifestyle intervention to increase cardiovascular health. Due to the research pause during the Coronavirus Disease (COVID-19) pandemic, a virtual community engagement (VCE) process was co-designed with community stakeholders and evaluated for its effect on retention for the clinical trial. VCE via weekly virtual video conference sessions occurred for 9 weeks as a run-in phase prior to in-person research activities. Data collected during sessions included attendance, anecdotes on acceptability, and topical requests for subsequent weeks. Content analysis was performed on scribe notes from sessions to ascertain themes describing the implementation and participant perceptions of the VCE. Descriptive statistics were used to analyze quantitative data. The VCE provided opportunities to co-create a safe atmosphere in small groups, discuss mental health, foster trust, capitalize on the power of spirituality, and establish a brotherhood. Following the VCE run-in phase, 74 of 100 participants remained engaged for participation in the Black Impact study. The VCE described provides a framework that can be used to retain Black men during study delays or disruptions through fostering engagement and building community among participants and researchers.

Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions-A report from the "Health Equity through Diversity" seminar series.

INTRODUCTION: In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts. METHODS: Two webinars in a four-part series, titled "Health Equity through Diversity," were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room's conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes. RESULTS: The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential. CONCLUSIONS: Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.

Reproductive Experiences and Cardiovascular Disease Care in Pregnancy-Capable and Postmenopausal Individuals: Insights From the American Heart Association Research Goes Red Registry.

To evaluate preconception health and adverse pregnancy outcome (APO) awareness in a large population-based registry. We examined data from the Fertility and Pregnancy Survey of the American Heart Association Research Goes Red Registry to questions regarding prenatal health care experiences, postpartum health, and awareness of the association of APOs with cardiovascular disease (CVD) risk. Among postmenopausal individuals, 37% were unaware that APOs were associated with long-term CVD risk, significantly varying by race-ethnicity. Fifty-nine percent of participants were not educated regarding this association by their providers, and 37% reported providers not assessing pregnancy history during current visits, significantly varying by race-ethnicity, income, and access to care. Only 37.1% of respondents were aware that CVD was the leading cause of maternal mortality. There is an urgent, ongoing need for more education on APOs and CVD risk, to improve the health-care experiences and postpartum health outcomes of pregnant individuals.

Reproductive Experiences and Cardiovascular Disease Care in Pregnancy Capable and Post-Menopausal Individuals: Insights from the American Heart Association Research Goes Red Registry.

Background: Information on reproductive experiences and awareness of adverse pregnancy outcomes (APOs) and cardiovascular disease (CVD) risk among pregnancy-capable and post-menopausal individuals has not been well described. We sought to evaluate preconception health and APO awareness in a large population-based registry. Methods: Data from the Fertility and Pregnancy Survey of the American Heart Association Research Goes Red Registry (AHA-RGR) were used. Responses to questions pertaining to prenatal health care experiences, postpartum health, and awareness of the association of APOs with CVD risk were used. We summarized responses using proportions for the overall sample and by stratifications, and we tested differences using the Chi-squared test. Results: Of 4,651individuals in the AHA-RGR registry, 3,176 were of reproductive age, and 1,475 were postmenopausal. Among postmenopausal individuals, 37% were unaware that APOs were associated with long-term CVD risk. This varied by different racial/ethnic groups (non-Hispanic White: 38%, non-Hispanic Black: 29%, Asian: 18%, Hispanic: 41%, Other: 46%; P = 0.03). Fifty-nine percent of the participants were not educated regarding the association of APOs with long-term CVD risk by their providers. Thirty percent of the participants reported that their providers did not assess pregnancy history during current visits; this varied by race-ethnicity ( P = 0.02), income ( P = 0.01), and access to care ( P = 0.02). Only 37.1% of the respondents were aware that CVD was the leading cause of maternal mortality. Conclusions: Considerable knowledge gaps exist in the association of APOs with CVD risk, with disparities by race/ethnicity, and most patients are not educated on this association by their health care professionals. There is an urgent and ongoing need for more education on APOs and CVD risk, to improve the health-care experiences and postpartum health outcomes of pregnant individuals.

The Role of Social Support in Cardiovascular Clinical Trial Participation among Black Men: Black Impact.

BACKGROUND: Attainment of the American Heart Association's Life's Simple 7 (LS7) metrics reduces cardiovascular disease (CVD) risk; yet, Black Americans have the lowest LS7 attainment among all communities, the highest rate of CVD mortality, and low clinical trial participation. Social support is positively correlated with chronic disease self-management. Here, we describe the role of social support in a single-arm pilot clinical trial of a community-based lifestyle intervention among Black American men. METHODS: The 24-week intervention featured weekly team-based physical activity and LS7-themed education. Seventy-four Black men participated in the intervention; twenty agreed to participate in exit surveys via one of three semi-structured focus groups. Data were transcribed verbatim and analyzed using content analysis framed by House's social support framework. RESULTS: Participants reported support from both peers and health coaches. The sub-themes of social support among peers were: (1) acknowledgement, understanding, and validation, (2) inspiration, (3) sense of community, (4) fear of disappointing fellow participants, and (5) group synergy. The sub-themes of social support from the health coaches and study team staff included: (1) contemplation of current health status, (2) racial concordance of health coaches and study team staff, (3) investment of the research team, (4) incentives, (5) access to healthcare providers, and (6) the COVID-19 pandemic. Emotional support was the most frequently discussed theme. CONCLUSIONS: Social support, especially emotional support, from peers and health coaches was a driver of clinical trial participation among participants. The intervention created a positive social environment and decreased medical mistrust. This intervention may provide a framework by which to facilitate clinical trial participation among Black men.