Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community

Abstract Background African Americans living in the rural south have the highest prevalence of cardiovascular disease (CVD) risk in the United States. Given this geographic and racial disparity, intervention implementation needs to be evaluated for effectiveness and feasibility with African Americans in the rural south. Methods The trial developed out of a community-based participatory research partnership, Project GRACE, and community partners who are collaborators throughout the study. Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from PREMIER, an evidence-based treatment targeting multiple CVD risk factors. 140 participants will be recruited through 8 community- or faith-based organizations to participate in the intervention. Through matched pair randomization, organizations will be randomized to begin immediately after baseline data collection (Arm 1) or delayed 6 months (Arm 2). Data collection will occur at baseline, 6, 12, and 18 months. The primary outcome is change in body weight. In addition to assessing effectiveness, the study will also evaluate process and feasibility outcomes through quantitative and qualitative data collection. Discussion This study will contribute to CVD prevention research and likely have a positive impact on the rural, African American community where the trial occurs. Our study is unique in its use of community partnerships to develop, implement, and evaluate the intervention. We expect that this approach will enhance the feasibility of the trial, as well as future dissemination and sustainability of the intervention. Trial registration Clinical Trials, NCT02707432 . Registered 13 March 2016

Serum Response Factor Regulates Immediate Early Host Gene Expression in Toxoplasma gondii-Infected Host Cells

Toxoplasma gondii is a wide spread pathogen that can cause severe and even fatal disease in fetuses and immune-compromised hosts. As an obligate intracellular parasite, Toxoplasma must alter the environment of its host cell in order to establish its replicative niche. This is accomplished, in part, by secretion of factors into the host cell that act to modulate processes such as transcription. Previous studies demonstrated that genes encoding transcription factors such as c-jun, junB, EGR1, and EGR2 were amongst the host genes that were the most rapidly upregulated following infection. In cells stimulated with growth factors, these genes are regulated by a transcription factor named Serum Response Factor. Serum Response Factor is a ubiquitously expressed DNA binding protein that regulates growth and actin cytoskeleton genes via MAP kinase or actin cytoskeletal signaling, respectively. Here, we report that Toxoplasma infection leads to the rapid activation of Serum Response Factor. Serum Response Factor activation is a Toxoplasma-specific event since the transcription factor is not activated by the closely related protozoan parasite, Neospora caninum. We further demonstrate that Serum Response Factor activation requires a parasite-derived secreted factor that signals via host MAP kinases but independently of the host actin cytoskeleton. Together, these data define Serum Response Factor as a host cell transcription factor that regulates immediate early gene expression in Toxoplasma-infected cells

Multisite Randomized Trial of a Single-Session Versus Multisession Literacy-Sensitive Self-Care Intervention for Patients With Heart Failure

Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy

Researching COVID to Enhance Recovery (RECOVER) Adult Study Protocol: Rationale, Objectives, and Design

IMPORTANCE: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options

The Development and Implementation of a Resource Nurse in the Float Pool: A review of the Literature and a Pilot Study Plan

The Development and Implementation of a Resource Nurse in the Float Pool: A review of the Literature and a Pilot Study Plan. Crystal M Wiley, BSN, RN, CMSRN Background/Literature: It is pivotal that resources are available at the point of care allowing excellence in nursing care and exceptional outcomes. Currently, the staff have multiple resources to help with ethical dilemmas, patients who are unstable, and research. Discussion with leadership revealed a need for a support to busy units with a few newly hired staff and an interest in a resource nurse program to address these concerns and areas for improvement. Purpose: Develop and pilot a resource nurse position and effects amongst medical-surgical nurses safety, patient and staff satisfaction, job satisfaction, and staff retention and competence. Design: A resource nurse position was created and a pilot of the resource nurse will be implemented. Results would be yielded through a survey disseminated amongst staff to evaluate the resource nurse quarterly to determine the effectiveness of the resource nurse position amongst staff. Results: TBD Conclusions: TBD Time Frame: The estimated timeframe for the entire project is 1 year up to 1 year 3 months for review. Estimated completion: January 2019

Resiliency among Women's Health Initiative women aged 80 and older by race, ethnicity, and neighborhood socioeconomic status.

ObjectivesA comprehensive examination of resilience by race, ethnicity, and neighborhood socioeconomic status (NSES) among women aged ≥80 is needed, given the aging of the US population, increasing longevity, and growing racial and ethnic diversity.MethodsParticipants were women aged ≥80 enrolled in the Women's Health Initiative (WHI). Resilience was assessed with a modified version of the Brief Resilience Scale. Descriptive statistics and multiple linear regression examined the association of demographic, health, and psychosocial variables with resilience by race, ethnicity, and NSES.ResultsParticipants (n=29,367, median age=84.3) were White (91.4%), Black (3.7%), Hispanic (1.9%), and Asian (1.7%) women. There were no significant differences by race and ethnicity on mean resiliency scores (p=0.06). Significant differences by NSES were observed regarding mean resiliency scores between those with low NSES (3.94±0.83, out of 5) and high NSES (4.00±0.81). Older age, higher education, higher self-rated health, lower stress, and living alone were significant positive correlates of resilience in the sample. Social support was correlated with resilience among White, Black, and Asian women, but not for Hispanic women. Depression was a significant correlate of lower resilience, except among Asian women. Living alone, smoking, and spirituality were significantly associated with higher resilience among women with moderate NSES.DiscussionMultiple factors were associated with resilience among women aged ≥80 in the WHI. Despite some differing correlates of resilience by race, ethnicity, and NSES, there were many similarities. These results may aid in the design of resilience interventions for the growing, increasingly diverse population of older women

Trust in Community-Engaged Research Partnerships: A Methodological Overview of Designing a Multisite Clinical and Translational Science Awards (CTSA) Initiative.

Community-engaged research (CEnR) builds on the strengths of the Clinical and Translational Science Awards (CTSA) framework to address health in underserved and minority communities. There is a paucity of studies that identify the process from which trust develops in CEnR partnerships. This study responds to the need for empirical investigation of building and maintaining trust from a multistakeholder perspective. We conducted a multi-institutional pilot study using concept mapping with to better understand how trust, a critical outcome of CEnR partnerships, can act as "social capital." Concept mapping was used to collect data from the three stakeholder groups: community, health-care, and academic research partners across three CTSAs. Concept mapping is a mixed-methods approach that allows participants to brainstorm and identify factors that contribute to a concept and describe ways in which those factors relate to each other. This study offers important insights on developing an initial set of trust measures that can be used across CTSAs to understand differences and similarities in conceptualization of trust among key stakeholder groups, track changes in public trust in research, identify both positive and negative aspects of trust, identify characteristics that maintain trust, and inform the direction for future research

Multisite Randomized Trial of a Single-Session Versus Multisession Literacy-Sensitive Self-Care Intervention for Patients With Heart Failure

BACKGROUND: Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy. METHODS AND RESULTS: A 1-year, multisite, randomized controlled comparative effectiveness trial with 605 patients with HF. Those randomized to single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life (HFQOL) with pre-specified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio (IRR)=1.01 (95% Confidence Interval (CI): 0.83, 1.22). The effect of multisession training compared with single session training differed by literacy group: among low literacy, multisession yielded lower incidence of all-cause hospitalization and death: IRR=0.75 (0.45,1.25); and among higher literacy, multisession yielded higher incidence: IRR=1.22 (0.99,1.50) (interaction p=0.048). For HF-related hospitalization: among low literacy, multisession yielded lower incidence: IRR=0.53 (95% CI: 0.25,1.12); and among higher literacy, multisession yielded higher incidence: IRR=1.32 (95% CI: 0.92,1.88) (interaction p=0.005). HFQOL improved more for patients receiving multisession compared with single session at 1 and 6 months, but the difference at 12 months was smaller. Effects on HFQOL did not differ by literacy. CONCLUSIONS: Overall, an intensive multisession intervention did not change clinical outcomes compared with a single session intervention. People with low literacy appear to benefit more from multisession than people with higher literacy. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; Identifier: NCT00378950