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.
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.
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.
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.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Despite improvements in mortality rates over the past several decades, cardiovascular (CV) disease remains the leading cause of death for African-Americans (AAs). Innovative approaches through mobile ...health (mHealth) interventions have the potential to support lifestyle change for CV disease prevention among AAs. We aimed to translate a behavioral theory-informed, evidence-based, face-to-face health education program into an mHealth lifestyle intervention for AAs. We describe the design and development of a culturally relevant, CV health and wellness digital application (app) and pilot testing using a community-based participatory research (CBPR) approach with AA churches.
This mixed methods study used a 4-phase iterative development process for intervention design with the AA community. Phase 1 included focus groups with AA community members and church partners (n = 23) to gain insight regarding potential app end user preferences. In Phase 2, the interdisciplinary research team synthesized Phase 1 input for preliminary app design and content development. Phase 3 consisted of a sequential 3-meeting series with church partners (n = 13) for iterative app prototyping (assessment, cultural tailoring, final review). Phase 4, a single group pilot study among AA church congregants (n = 50), assessed app acceptability, usability, and satisfaction.
Phase 1 focus groups indicated general and health-related apps preferences: multifunctional, high-quality graphics/visuals, evidence-based, yet simple health information and social networking capability. Phase 2 integrated these preferences into the preliminary app prototype. Phase 3 feedback was used to refine the app prototype for pilot testing. Phase 4 pilot testing indicated high app acceptability, usability, and satisfaction.
This study illustrates integration of formative and CBPR approaches to design a culturally relevant, mHealth lifestyle intervention to address CV health disparities among AAs. Given the positive app perceptions, our study supports the use of an iterative development process by others interested in implementing an mHealth lifestyle intervention for racial/ethnic minority communities.
Clinicaltrials.gov NCT03084822.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
With Minneapolis, Minnesota, partners, we developed a community-based participatory intervention using a mobile health application to provide actionable data to communities. More than 550 ...participants completed the survey. Key messages included strengths in our homes, neighborhoods, and faith communities. Key challenges were related to substance use and sleeping. We jointly conducted virtual community meetings such as webinars, Facebook Live shows, and online newsletters to begin to shift the community narrative from deficits to whole-person health, including strengths. (
. 2022;112(S3):S275-S278. https://doi.org/10.2105/AJPH.2022.306852).
Purpose
To explore resilience in the context of whole‐person health and the social determinants of health at the individual and community levels using large, standardized nursing datasets.
Design
A ...retrospective, observational, correlational study of existing deidentified Health Insurance Portability and Accountability Act (HIPAA)‐compliant data using the Omaha System and its equivalent, Simplified Omaha System Terms.
Methods
We used three samples to explore for patterns of resilience: pre‐COVID‐19 community‐generated data (N = 383), pre‐COVID‐19 clinical documentation data (N = 50,509), and during‐COVID‐19 community‐generated data (N = 102). Community participants used the My Strengths + My Health (MSMH) app to generate the two community datasets. The clinical data were obtained from the Omaha System Data Collaborative. We operationalized resilience as Omaha System Status scores of 4 (minimal signs or symptoms) or 5 (no signs or symptoms) as a discrete strengths measure for each of 42 Omaha System problem concepts. We used visualization techniques and standard descriptive and inferential statistics for analysis.
Findings
It was feasible to examine resilience, operationalized as strengths by problem concept, within existing Omaha System or Simplified Omaha System Terms (MSMH) data. We identified several patterns indicating strengths and resilience that were consistent with literature related to community connectedness for community participants, and sleep for individuals in the clinical data.
Conclusions
When used consistently, the Omaha System within MSMH enabled robust data collection for a comprehensive, holistic assessment, resulting in better whole‐person data including strengths, and enabled us to discover a potentially useful approach for defining resilience in new ways using standardized nursing data.
Clinical Relevance
The notion that how we assess individuals and communities (i.e., the completeness of our assessments in relation to whole‐person health) determines what we can know about resilience is seemingly in opposition to the critical need to decrease documentation burden, despite the potential to shift from a problem deficit‐based assessment to one of strengths and resilience. However, a patient‐facing comprehensive assessment that includes resilience and the social determinants of health can provide a transformative, whole‐person platform for strengths‐based care and population management.
Objective To compare a US clinical trial of gonadotropin therapy for IVF with a similar European trial to determine what factors may explain the higher clinical pregnancy rate in the US trial. Design ...Comparison of baseline, treatment, and outcome variables in the United States (US) and European trials. Setting IVF practices in the US (n=4) and Europe (n=6). Patient(s) 297 women undergoing IVF. Intervention(s) None. Main Outcome Measure(s) Clinical pregnancy rate. Result(s) Clinical pregnancy rates were 43.4% in the US compared with 29.7% in Europe (p=0.016), with a live birth rate of 38.2% versus 27.6% (p=0.064). This difference in clinical pregnancy rate could not be explained by differences in the US versus Europe for number of embryos transferred (2.3 vs. 2.6) or female age (34.6 vs. 30.4). Although the starting dose of gonadotropin was higher in the US trial compared with the European trial (300 versus 225 IU), the total dose of gonadotropin was only slightly higher in the US. In multiple logistic regression analysis of 81 pretransfer variables on clinical pregnancy, the only two found to be significant predictors of outcome were baseline endometrial thickness following down-regulation and number of days of gonadotropin treatment. Conclusion(s) This study suggests the possibility that US pregnancy rates may be higher in part because of differences in down-regulation or gonadotropin dosing. Other factors not assessed in these studies or in national datasets likely also contribute to the difference in pregnancy rates.
OBJECTIVES/GOALS: The COVID-19 pandemic disrupted established social support networks (faith-based, community, family, friends), resulting in unprecedented health-related, financial, and employment ...challenges among African Americans (AAs). This study explores the psychosocial influences of the pandemic on the health and wellness of AAs. METHODS/STUDY POPULATION: The FAITH! (Fostering African-American Improvement in Total Health!) Program, an academic-community partnership with AA churches, shifted focus to COVID-19 prevention in AA communities. Funded by the Mayo Clinic Center for Clinical and Translation Sciences, this cross-sectional study recruited AA adults from FAITH!-affiliated churches and social media to complete a survey exploring the personal impact of the pandemic from hardships (e.g., food and housing insecurity, paying utilities) on healthy lifestyle (HL). The primary outcome was difficulty maintaining a HL during the pandemic. Logistic regression (odds ratios and associated 95% confidence intervals (CIs)) was used to examine the associations between difficulty maintaining a HL and factors including COVID-19 hardships and mental health. RESULTS/ANTICIPATED RESULTS: Participants (N=169, 71.4% female, 41.4% essential workers) had a mean age SD of 49.4 14.9 years. Over half (91/169, 54%) reported difficulty maintaining a HL. Those reporting unemployment (OR 2.3; 95% CI 1.2,4.4; p=0.008), difficulty paying rent (OR 4.1; 95% CI 2.1,8.6; p<0.001), or food/utilities (OR 5.5; 95% CI 2.7,11.5; p<0.001) all had greater odds of difficulty maintaining a HL. High stress (≥5/10, scale 1-10) was associated with difficulty maintaining a HL (OR 4.1; 95% CI 2.1,8.5; p<0.001) compared to AAs with low stress. Negative mental health (depression (OR 3.4; 95% CI 1.0,13.7; p<0.001), anger (OR 2.5; 95% CI 0.5,18.9; p=0.005), and nervousness (OR 4.1; 95% CI 1.1,19.5; p=0.003) was associated with difficulty maintaining a HL compared to AAs with positive mental health. DISCUSSION/SIGNIFICANCE: Our study findings revealed that COVID-19 hardships, stress, and negative mental health impacted the ability of AAs to maintain a HL. These issues should be considered in the design and implementation of community-based health programs to promote healthy living during future public health emergencies.
African Americans continue to have suboptimal cardiovascular health (CVH) related to diet and physical activity (PA) behaviors compared with White people. Mobile health (mHealth) interventions are ...innovative platforms to improve diet and PA and have the potential to mitigate these disparities. However, these are understudied among African Americans.
This study aims to examine whether an mHealth lifestyle intervention is associated with improved diet and PA-related psychosocial factors in African Americans and whether these changes correlate with diet and PA behavioral change.
This study is a retrospective analysis evaluating changes in diet and PA-related self-regulation, social support, perceived barriers, and CVH behaviors (daily fruit and vegetable intake and moderate-intensity PA MPA per week) in 45 African American adults (mean age 48.7 years, SD 12.9 years; 33/45, 73% women) enrolled in the FAITH! (Fostering African American Improvement in Total Health) app pilot study. The intervention is a 10-week, behavioral theory-informed, community-based mHealth lifestyle intervention delivered through a mobile app platform. Participants engaged with 3 core FAITH! app features: multimedia education modules focused on CVH with self-assessments of CVH knowledge, self-monitoring of daily fruit and vegetable intake and PA, and a sharing board for social networking. Changes in self-reported diet and PA-related self-regulation, social support, perceived barriers, and CVH behaviors were assessed by electronic surveys collected at baseline and 28 weeks postintervention. Changes in diet and PA-related psychosocial factors from pre- to postintervention were assessed using paired 2-tailed t tests. The association of changes in diet and PA-related psychosocial variables with daily fruit and vegetable intake and MPA per week was assessed using Spearman correlation. Associations between baseline and 28-week postintervention changes in diet and PA-related psychosocial measures and CVH behaviors with covariates were assessed by multivariable linear regression.
Participants reported improvements in 2 subscales of diet self-regulation (decrease fat and calorie intake, P=.01 and nutrition tracking, P<.001), one subscale of social support for healthy diet (friend discouragement, P=.001), perceived barriers to healthy diet (P<.001), and daily fruit and vegetable intake (P<.001). Improvements in diet self-regulation (increase fruit, vegetable, and grain intake, and nutrition tracking) and social support for healthy diet (friend encouragement) had moderate positive correlations with daily fruit and vegetable intake (r=0.46, r=0.34, and r=0.43, respectively). A moderate negative correlation was observed between perceived barriers to healthy diet and daily fruit and vegetable intake (r=-0.25). Participants reported increases in PA self-regulation (P<.001). Increase in social support subscales for PA (family and friend participation) had a moderate positive correlation with MPA per week (r=0.51 and r=0.61, respectively).
Our findings highlight key diet and PA-related psychosocial factors to target in future mHealth lifestyle interventions aimed at promoting CVH in African Americans.
Background: Opioid misuse and abuse is a longstanding concern, particularly in underserved communities. Community-level data is needed to understand how to best address the opioid crisis. A ...strengths-based whole-person approach can offset challenges in working to maximize individual health.
Objectives: Project objectives included acquiring and providing data to the community to engage members in meaningful conversations about opioid misuse and abuse and gather insights to shape a response to the opioid crisis.
Methods: University of Minnesota School of Nursing faculty collaborated with community partner Hue-MAN Partnership, to develop and implement a Community Opioid Survey at neighborhood meetings. The MyStrengths+MyHealth assessment was used to identify strengths of community members. Community meetings included introductions by the Hue-MAN Partnership, presentation of the survey data, and facilitated discussion to involve community members in data interpretation and solution development.
Results: Data was collected at 11 community meetings between June 2018 and May 2019. Approximately half of respondents had been affected by opioid misuse or overdose; oxycodone was the most frequent opioid involved; community clinics were the most available resource; and community education was identified as a needed resource to reduce misuse and overdose. Communities perceived and used language differently in talking about opioids.
Conclusion: The community-academic- partnership enabled collection of community-specific data that may have been inaccessible to researchers working alone. Access to community-specific data holds promise for increasing research relevance and for engaging community knowledge and needs.
Background:
COVID-19 vaccine hesitancy in the United States is high, with at least 63 million unvaccinated individuals to date. Socioeconomically disadvantaged populations experience lower COVID-19 ...vaccination rates despite facing a disproportionate COVID-19 burden.
Objective:
To assess the factors associated with COVID-19 vaccine acceptance among under-resourced, adult patients.
Methods:
Participants were patients receiving care at a Federally Qualified Health Center (FQHC) in St. Paul, Minnesota. Data were collected via multiple modes over 2 phases in 2020 (self-administered electronic survey) and 2021 (study team-administered survey by telephone, self-administered written survey) to promote diversity and inclusion for study participation. The primary outcome was COVID-19 vaccine acceptance. Using logistic regression analysis, associations between vaccine acceptance and factors including risk perception, concerns about the COVID-19 vaccine, social determinants of health (SDOH), co-morbidities, pandemic-induced hardships, and stress were assessed by adjusted odds ratios (AORs) and 95% confidence intervals (CI).
Results:
One hundred sixty-eight patients (62.5% female; mean age SD: 49.9 17.4 years; 32% <$20 000 annual household income; 69% <college education) were included in the study. Sixty-one percent of the patients received or were willing to receive the vaccine. Risk perception was positively associated with vaccine acceptance (AOR: 5.3; 95% CI: 2.5, 11.5, P < .001), while concerns about the vaccine (eg, safety, side effects, rapid development of the vaccine, etc.) were negatively associated with vaccine acceptance (all P < .001). SDOH, co-morbidities, pandemic-induced hardships were not associated with vaccine acceptance.
Conclusions:
Our study in a socioeconomically disadvantaged population suggests that risk perception is associated with an increased likelihood of vaccine acceptance, while concerns about the COVID-19 vaccine are associated with a lower likelihood of vaccine acceptance. As these factors could impact vaccine uptake, consistent, innovative, and context-specific risk communication strategies may improve vaccine coverage in this population.
African American individuals are at a higher risk of premature death from cardiovascular diseases than White American individuals, with disproportionate attributable risk from uncontrolled ...hypertension. Given their high use among African American individuals, mobile technologies, including smartphones, show promise in increasing reliable health information access. Culturally tailored mobile health (mHealth) interventions may promote hypertension self-management among this population.
This formative study aimed to assess the feasibility of integrating an innovative mHealth intervention into clinical and community settings to improve blood pressure (BP) control among African American patients.
A mixed methods study of African American patients with uncontrolled hypertension was conducted over 2 consecutive phases. In phase 1, patients and clinicians from 2 federally qualified health centers (FQHCs) in the Minneapolis-St Paul, Minnesota area, provided input through focus groups to refine an existing culturally tailored mHealth app (Fostering African-American Improvement in Total Health! FAITH! App) for promoting hypertension self-management among African American patients with uncontrolled hypertension (renamed as FAITH! Hypertension App). Phase 2 was a single-arm pre-post intervention pilot study assessing feasibility and patient satisfaction. Patients receiving care at an FQHC participated in a 10-week intervention using the FAITH! Hypertension App synchronized with a wireless BP monitor and community health worker (CHW) support to address social determinants of health-related social needs. The multimedia app consisted of a 10-module educational series focused on hypertension and cardiovascular risk factors with interactive self-assessments, medication and BP self-monitoring, and social networking. Primary outcomes were feasibility (app engagement and satisfaction) and preliminary efficacy (change in BP) at an immediate postintervention assessment.
In phase 1, thirteen African American patients (n=9, 69% aged ≥50 years and n=10, 77% women) and 16 clinicians (n=11, 69% aged ≥50 years; n=14, 88% women; and n=10, 63% African American) participated in focus groups. Their feedback informed app modifications, including the addition of BP and medication tracking, BP self-care task reminders, and culturally sensitive contexts. In phase 2, sixteen African American patients were enrolled (mean age 52.6, SD 12.3 years; 12/16, 75% women). Overall, 38% (6/16) completed ≥50% of the 10 education modules, and 44% (7/16) completed the postintervention assessment. These patients rated the intervention a 9 (out of 10) on its helpfulness in hypertension self-management. Qualitative data revealed that they viewed the app as user-friendly, engaging, and informative, and CHWs were perceived as providing accountability and support. The mean systolic and diastolic BPs of the 7 patients decreased by 6.5 mm Hg (P=.15) and 2.8 mm Hg (P=.78), respectively, at the immediate postintervention assessment.
A culturally tailored mHealth app reinforced by CHW support may improve hypertension self-management among underresourced African American individuals receiving care at FQHCs. A future randomized efficacy trial of this intervention is warranted.
ClinicalTrials.gov NCT04554147; https://clinicaltrials.gov/ct2/show/NCT04554147.
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