College students' knowledge and attitudes toward clinical trials and their relationship with willingness to participate in COVID-19 trials or vaccines.

OBJECTIVE: We examined clinical trial knowledge and attitudes, and their relationship with willingness to participate in COVID-19 vaccine trials, and willingness to accept a COVID-19 vaccine among college students. PARTICIPANTS: 331 undergraduates: mean age 25; 72% women; and 78% white. METHODS: We administered an online, anonymous survey to undergraduate students in July, 2020, during the COVID-19 pandemic. RESULTS: The mean clinical trial knowledge score was 65% (SD = 16) correct. The mean attitudes toward clinical trials score (1 most negative: 5 most positive) was 3.3 (SD = 0.5). Attitudes toward clinical trials were associated with likelihood of COVID-19 trial participation (positive 76% vs. negative 35%, p = 0.001) and a trend toward likelihood of accepting a COVID-19 vaccine if available (positive 89% vs. negative 67%, p = 0.066). CONCLUSIONS: General clinical trial knowledge and attitudes appear to be important targets for educational interventions. Furthermore, fostering positive attitudes may lead to improved COVID-19 trial participation and vaccine uptake.

A Physical Activity Just-in-time Adaptive Intervention Designed in Partnership With a Predominantly Black Community: Virtual, Community-Based Participatory Design Approach.

BACKGROUND: Black people are disproportionally impacted by hypertension. New approaches for encouraging healthy lifestyles are needed to reduce hypertension and promote health equity in Black communities. OBJECTIVE: In this report, we describe the early-stage, virtual design of a just-in-time adaptive intervention (JITAI) to increase physical activity in partnership with members of a low-income, predominantly Black community. METHODS: The hallmark of JITAIs is highly contextualized mobile app push notifications. Thus, understanding participants' context and determinants of physical activity are critical. During the height of the COVID-19 pandemic, we conducted virtual discovery interviews and analysis guided by the Behavior Change Wheel (which focuses on participants' capacity, opportunity, and motivation to engage in physical activity), as well as empathy mapping. We then formed a community-academic participatory design team that partnered in the design sprint, storyboarding, and paper prototyping. RESULTS: For this study, 5 community members participated in the discovery interviews, 12 stakeholders participated in the empathy mapping, 3 community members represented the community on the design team, and 10 community members provided storyboard or paper prototyping feedback. Only one community member had used videoconferencing prior to partnering with the academic team, and none had design experience. A set of 5 community-academic partner design principles were created: (1) keep users front and center, (2) tailor to the individual, (3) draw on existing motivation, (4) make physical activity feel approachable, and (5) make data collection transparent yet unobtrusive. To address community-specific barriers, the community-academic design team decided that mobile app push notifications will be tailored to participants' baseline mobility level and community resources (eg, local parks and events). Push notifications will also be tailored based on the day (weekday versus weekend), time of day, and weather. Motivation will be enhanced via adaptive goal setting with supportive feedback and social support via community-generated notifications. CONCLUSIONS: We completed early-stage virtual design of a JITAI in partnership with community participants and a community design team with limited design and videoconferencing experience. We found that designing JITAIs with the community enables these interventions to address community-specific needs, which may lead to a more meaningful impact on users' health.

Process Evaluation of a Faith-Based Multicomponent Behavioral Intervention to Reduce Stroke Risk in Mexican Americans in a Catholic Church Setting: The SHARE (Stroke Health and Risk Education) Project.

Church-based stroke prevention programs for Hispanics are underutilized. The Stroke Health and Risk Education (SHARE) project, a multicomponent cluster-randomized trial, addressed key stroke risk factors among predominantly Mexican Americans in a Catholic Church setting. Process evaluation components (implementation, mechanisms of impact, and context) are described. Partner support promoted positive health behavior change. Motivational interviewing calls were perceived as helpful, however, barriers with telephone delivery were encountered. Intervention exposure was associated with theory constructs for targeted behaviors. We conclude that health behavior interventions to prevent stroke can be successfully implemented for Mexican Americans within a Catholic Church setting, with parish priest support.

Interprofessional Collaboration in Public Health.

ABSTRACT: Public health departments exemplify interprofessional collaboration. Nursing and public health education students are required to complete practicum hours or an internship respectively in community health, yet placements at health departments are limited and competitive. This study evaluated the effects of an interprofessional education intervention on community health nursing and health education students' current interprofessional awareness and understanding, and intent to collaborate interprofessionally. Results showed that the majority of participants felt that their interprofessional awareness, understanding, and intent to collaborate increased. This intervention helped bring an example of the health department experience to students and demonstrate its interprofessional nature.

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.

BACKGROUND: Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS: Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION: The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.

Reach Out Emergency Department: Partnering With an Economically Disadvantaged Community in the Development of a Text-Messaging Intervention to Address High Blood Pressure.

Background. Hypertension affects nearly 30% of the U.S. adult population. Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved. We present the intervention development of Reach Out, a health behavior theory-based, mobile health intervention to reduce blood pressure among hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans. Aims. To describe the process of designing and refining text messages currently being implemented in the Reach Out randomized controlled trial. Method. We used a five-step framework to develop the text messages used in Reach Out. These steps included literature review and community formative research, conception of a community-centered behavioral theoretical framework, draft of evidence-based text messages, community review, and revision based on community feedback and finalization. Results. The Reach Out development process drew from pertinent evidence that, combined with community feedback, guided the development of a community-centered health behavior theory framework that led to development of text messages. A total of 333 generic and segmented messages were created. Messages address dietary choices, physical activity, hypertension medication adherence, and blood pressure monitoring. Discussion. Our five-step framework is intended to inform future text-messaging-based health promotion efforts to address health issues in vulnerable populations. Conclusion. Text message-based health promotion programs should be developed in partnership with the local community to ensure acceptability and relevance.

Effectiveness of a short video-based educational intervention on factors related to clinical trial participation in adolescents and young adults: a pre-test/post-test design.

BACKGROUND: Poor clinical trial enrollment continues to be pervasive and is especially problematic among young adults and youth, and among minorities. Efforts to address barriers to enrollment have been predominantly focused on adult diseased populations. Because older adults may already have established attitudes, it is imperative to identify strategies that target adolescents and young adults. The purpose of this study was to test the effectiveness of an educational video on factors related to clinical trial participation among a healthy adolescent and young adult population. METHODS: Participants completed a 49-item pre-test, viewed a 10-min video, and completed a 45-item post-test to assess changes in attitudes, knowledge, self-efficacy, receptivity to, and intention to participate (primary outcome) in clinical trials. Descriptive statistics, paired samples t-tests, and Wilcoxon signed-rank tests were conducted. RESULTS: The final analyses included 935 participants. The mean age was 20.7 years, with almost 70% aged 18 to 20 years. The majority were female (73%), non-Hispanic (92.2%), white (70%), or African American (20%). Participants indicated a higher intention to participate in a clinical trial (p < 0.0001) and receptivity to hearing more about a clinical trial (p < 0.0001) after seeing the video. Intention to participate (definitely yes and probably yes) increased by an absolute 18% (95% confidence interval 15-22%). There were significant improvements in attitudes, knowledge, and self-efficacy scores for all participants (p < 0.0001). CONCLUSIONS: The results of this study showed strong evidence for the effectiveness of a brief intervention on factors related to participation in clinical trials. This supports the use of a brief intervention, in a traditional educational setting, to impact the immediate attitudes, knowledge, self-efficacy, and intention to participate in clinical trial research among diverse, healthy adolescents and young adults.

Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans.

Innovative strategies are needed to reduce the hypertension epidemic among African Americans. Reach Out was a faith-collaborative, mobile health, randomized, pilot intervention trial of four mobile health components to reduce high blood pressure (BP) compared to usual care. It was designed and tested within a community-based participatory research framework among African Americans recruited and randomized from churches in Flint, Michigan. The purpose of this pilot study was to assess the feasibility of the Reach Out processes. Feasibility was assessed by willingness to consent (acceptance of randomization), proportion of weeks participants texted their BP readings (intervention use), number lost to follow-up (retention), and responses to postintervention surveys and focus groups (acceptance of intervention). Of the 425 church members who underwent BP screening, 94 enrolled in the study and 73 (78%) completed the 6-month outcome assessment. Median age was 58 years, and 79% were women. Participants responded with their BPs on an average of 13.7 (SD = 10.7) weeks out of 26 weeks that the BP prompts were sent. All participants reported satisfaction with the intervention. Reach Out, a faith-collaborative, mobile health intervention was feasible. Further study of the efficacy of the intervention and additional mobile health strategies should be considered.

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

BACKGROUND AND PURPOSE: The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. METHODS: Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level. RESULTS: Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (-123.17 mg/d [-194.76, -51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (-27 metabolic equivalent-minutes per week [-526, 471], P=0.56). CONCLUSIONS: This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.

Adolescent knowledge and attitudes related to clinical trials.

BACKGROUND OR AIMS: Poor enrollment plagues most clinical trials. Furthermore, despite mandates to improve minority representation in clinical trial participation, little progress has been made. We investigated the knowledge and attitudes of adolescents related to clinical trials and made race/ethnicity comparisons in an attempt to identify a possible educational intervention target. METHODS: Students aged 13-18 years in southeast Michigan were offered participation through a class at one high school or two academic summer enrichment programs that drew from multiple high schools (73% response). Questionnaires previously validated in adults were administered. Non-Hispanic whites were compared with minorities using Wilcoxon rank-sum tests. RESULTS: Of the 82 respondents, the median age was 16 years (interquartile range: 15-17 years); 22 (28%) were white, 41 (51%) were African American, 11 (14%) were multiracial, 2 (2%) were American Indian or Alaska Native, 1 (1%) was Asian, 3 (4%) were Native Hawaiian or other Pacific Islander, and 2 respondents did not report a race (but did report Hispanic ethnicity). Nine (12%) were Hispanic. Only 27 (33%) had ever heard of a clinical trial. On a scale from 1 (most receptive) to 5 (least receptive) for learning more about a clinical trial for a relevant medical condition, the median score was 2 (interquartile range: 1-3) and for participating in a clinical trial for a relevant medical condition was 2 (interquartile range: 2-3). Overall knowledge was poor, with a median of 46% (interquartile range: 23%-62%) of knowledge answers correct. Knowledge was reduced (p = 0.0006) and attitudes were more negative (p = 0.05) in minorities than non-Hispanic whites, while minorities also endorsed more substantial barriers to trial participation (p = 0.0002). Distrust was similar between minority students and non-Hispanic whites (p = 0.15), and self-efficacy was greater in non-Hispanic whites (p = 0.05). CONCLUSION: Educational interventions directed toward adolescents that address knowledge, attitudes, and distrust in order to improve clinical trial awareness and receptivity overall are needed and may represent a tool to address disparities in minority enrollment in clinical trials.

Stroke Health and Risk Education (SHARE): design, methods, and theoretical basis.

BACKGROUND: Stroke is a disease with tremendous individual, family, and societal impact across all race/ethnic groups. Mexican Americans, the largest subgroup of Hispanic Americans, are at even higher risk of stroke than European Americans. AIM: To test the effectiveness of a culturally sensitive, church-based, multi-component, motivational enhancement intervention for Mexican Americans and European Americans in reducing stroke risk factors. METHODS: Participants enroll in family or friendship pairs, from the same Catholic church in the Corpus Christi Texas area, and are encouraged to change diet and physical activity behaviors and provide support for behavior change to their partners. Churches are randomized to either the intervention or control group. Goal enrollment for each of the 10 participating churches is 40 participant pairs. The intervention consists of self-help materials (including a motivational short film, cookbook/healthy eating guide, physical activity guide with pedometer, and photonovella), five motivational interviewing calls, two tailored newsletters, parish health promotion activities and environmental changes, and a peer support workshop where participants learn to provide autonomy supportive counseling to their partner. SHARE's three primary outcomes are self-reported sodium intake, fruit and vegetable intake, and level of physical activity. Participants complete questionnaires and have measurements at baseline, six months, and twelve months. Persistence testing is performed at 18 months in the intervention group. The trial is registered with clinicaltrials.gov (NCT01378780).

Application of a Web-based tailored health risk assessment in a work-site population.

This article presents an examination of the feasibility of implementing a Web-based tailored health risk assessment (HRA) as part of a University-based work-site health promotion program. Although the effectiveness of tailoring has been well established in the research literature, tailoring health messages for the purposes of health promotion and behavior change is only now starting to be used and evaluated in real-world settings. Key issues to be examined include the feasibility of delivery of a web-based tailored HRA, utility of data gathered for program planning, participation rates compared to traditional programming, usability, and participant satisfaction with the HRA.

Tailored program evaluation: Past, present, future.

This paper discusses measurement issues related to the evaluation of computer-tailored health behavior change programs. As the first generation of commercially available tailored products is utilized in health promotion programming, programmers and researchers are becoming aware of the unique challenges that the evaluation of these programs presents. A project is presented that used an online tailored health behavior assessment (HBA) in a worksite setting. Process and outcome evaluation methods are described and include the challenges faced, and strategies proposed and implemented, for meeting them. Implications for future research in tailored program development, implementation, and evaluation are also discussed.