Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.

Importance: Black and Hispanic patients have high rates of recurrent stroke and uncontrolled hypertension in the US. The effectiveness of home blood pressure telemonitoring (HBPTM) and telephonic nurse case management (NCM) among low-income Black and Hispanic patients with stroke is unknown. Objective: To determine whether NCM plus HBPTM results in greater systolic blood pressure (SBP) reduction at 12 months and lower rate of stroke recurrence at 24 months than HBPTM alone among Black and Hispanic stroke survivors with uncontrolled hypertension. Design, Setting, and Participants: Practice-based, multicenter, randomized clinical trial in 8 stroke centers and ambulatory practices in New York City. Black and Hispanic study participants were enrolled between April 18, 2014, and December 19, 2017, with a final follow-up visit on December 31, 2019. Interventions: Participants were randomly assigned to receive either HBPTM alone (12 home BP measurements/week for 12 months, with results transmitted to a clinician; n = 226) or NCM plus HBPTM (20 counseling calls over 12 months; n = 224). Main Outcomes and Measures: Primary outcomes were change in SBP at 12 months and rate of recurrent stroke at 24 months. Final statistical analyses were completed March 14, 2024. Results: Among 450 participants who were enrolled and randomized (mean [SD] age, 61.7 [11.0] years; 51% were Black [n = 231]; 44% were women [n = 200]; 31% had ≥3 comorbid conditions [n = 137]; 72% had household income <$25 000/y [n = 234/324]), 358 (80%) completed the trial. Those in the NCM plus HBPTM group had a significantly greater SBP reduction than those in the HBPTM alone group at 12 months (-15.1 mm Hg [95% CI, -17.2 to -13.0] vs -5.8 mm Hg [95% CI, -7.9 to -3.7], respectively; P < .001). The between-group difference in SBP reduction at 12 months, adjusted for primary care physician clustering, was -8.1 mm Hg (95% CI, -11.2 to -5.0; P < .001) at 12 months. The rate of recurrent stroke was similar between both groups at 24 months (4.0% in the NCM plus HBPTM group vs 4.0% in the HBPTM alone group, P > .99). Conclusions and Relevance: Among predominantly low-income Black and Hispanic stroke survivors with uncontrolled hypertension, addition of NCM to HBPTM led to greater SBP reduction than HBPTM alone. Additional studies are needed to understand the long-term clinical outcomes, cost-effectiveness, and generalizability of NCM-enhanced telehealth programs among low-income Black and Hispanic stroke survivors with significant comorbidity. Trial Registration: Clinical Trials.gov Identifier: NCT02011685.

Development and Validation of a Stroke Literacy Assessment Test for Community Health Workers.

Community health workers (CHWs) are increasingly being required to perform complex health care activities, especially in community cardiovascular disease and stroke prevention. However, currently, there are no psychometrically validated instruments for assessing CHW competencies in these roles. This article describes the development and validation of the stroke literacy assessment test (SLAT)-pertaining to the Life's Simple Seven (LS7) risk factors for stroke-for evaluating CHWs' competencies in the context of education and training programs. The SLAT was developed using an iterative instrument design protocol, followed by empirically testing the instrument in 68 CHWs from the Columbia University Institute for Training Outreach and Community Health (InTOuCH) in New York. Data collection began in March 2021 and continued through May 2021. The evaluation was based on four types of validity evidence: (a) content validation with expert reviews of items and overall domain, (b) validation on examinee response processes with cognitive interviews, (c) item validation and diagnostic analysis, and (d) validity evidence based on expected directional group differences. In addition, the internal consistency reliability of the total test scores, with the best functioning items, were evaluated. Two such iterative cycles yielded a 34-item, written structured response test that assesses the factual knowledge and application levels of cognition, and demonstrates sufficient validity and reliability (Cronbach's α = .69) for use with CHWs specializing in stroke prevention efforts. The SLAT is a novel, valid, and reliable instrument that contributes to filling a critical gap in rigorous competency assessments for CHWs deployed in chronic disease prevention.

Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial.

Background: Colorectal cancer (CRC) is the second most lethal cancer in the United States (U.S.) with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, AAs are the least likely to undergo CRC screening, have precancerous colorectal polys removed, and have CRC detected at stages early enough for curative excision. In addition, compelling evidence links inflammatory dietary patterns to increased CRC and cardiovascular disease risk. Studies show that AA churches can successfully engage in health promotion activities including those related to cancer control. The current study seeks to leverage church-placed Community Health Workers (CHWs) to increase CRC screening and reduce CRC risk. Design and Methods: We aim to (1) increase guideline concordant CRC screening uptake using church-placed CHWs trained in screening with a validated instrument, Brief Intervention using Motivational Interviewing, and Referral to Treatment (SBIRT); and (2) reduce dietary risk factors (inflammatory dietary patterns) linked to CRC. The latter will be addressed by culturally adapting an existing, web-based lifestyle program called Alive!. Using a Hybrid Type 1 Implementation-Effectiveness cluster randomized design, we will randomize 22 AA churches into either the dual intervention arm (CHW-led SBIRT intervention plus Alive!) or a usual care arm comprised of CRC prevention educational pamphlets and a list of CRC screening sites. We will recruit 440 subjects and evaluate the effects of both arms on screening uptake (colonoscopy, fecal DNA) (primary outcome) and dietary inflammation score (secondary outcome) at 6-months follow up, and Life Simple7 (LS7) - a cardiovascular disease (CVD) risk score - at 6 months and 1-year (secondary outcome). Finally, guided by a racism-conscious adaptation of the Consolidated Framework for Implementation Research (CFIR), we will conduct a mixed-methods process evaluation with key stakeholders to understand multi-level influences on CRC screening and CVD risk behaviors. Discussion: Church-placed CHWs are trusted influential connectors between communities and health systems. Studies have shown that these CHWs can successfully implement health prevention protocols in churches, including those related to cancer control, making them potentially important community mediators of CRC screening uptake and CRC/CVD risk reduction. Trial registration: NCT05174286.

Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the second most lethal cancer in the United States (U.S.) with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, AAs are the least likely to undergo CRC screening, have precancerous colorectal polyps removed, and have CRC detected at stages early enough for curative excision. In addition, compelling evidence links inflammatory dietary patterns to increased CRC and cardiovascular disease risk. Studies show that AA churches can successfully engage in health promotion activities including those related to cancer control. The current study seeks to leverage church-placed Community Health Workers (CHWs) to increase CRC screening and reduce CRC risk. DESIGN AND METHODS: We aim to (1) increase guideline concordant CRC screening uptake using church-placed CHWs trained in screening with a validated instrument, Brief Intervention using Motivational Interviewing, and Referral to Treatment (SBIRT); and (2) reduce dietary risk factors (inflammatory dietary patterns) linked to CRC. The latter will be addressed by culturally adapting an existing, web-based lifestyle program called Alive!. Using a Hybrid Type 1 Implementation-Effectiveness cluster randomized design, we will randomize 22 AA churches into either the dual intervention arm (CHW-led SBIRT intervention plus Alive!) or a usual care arm comprised of CRC prevention educational pamphlets and a list of CRC screening sites. We will recruit 440 subjects and evaluate the effects of both arms on screening uptake (colonoscopy, fecal DNA) (primary outcome) and dietary inflammation score (secondary outcome) at 6-month follow-up, and Life Simple7 (LS7)-a cardiovascular disease (CVD) risk score-at 6 months and 1 year (secondary outcome). Finally, guided by a racism-conscious adaptation of the Consolidated Framework for Implementation Research (CFIR), we will conduct a mixed-methods process evaluation with key stakeholders to understand multi-level influences on CRC screening and CVD risk behaviors. DISCUSSION: Church-placed CHWs are trusted influential connectors between communities and health systems. Studies have shown that these CHWs can successfully implement health prevention protocols in churches, including those related to cancer control, making them potentially important community mediators of CRC screening uptake and CRC/CVD risk reduction. TRIAL REGISTRATION: NCT05174286; clinicaltrials.gov; August 31st, 2023.

"The Design and Acceptability of a Hip Hop Themed Integrated Nutrition Math Curriculum for Minoritized 5th Grade Students Using the Multisensory Multilevel Health Education Model".

Digital technology creates new opportunities to design multisensory learning experiences. Evidence suggests that digital innovation can greatly benefit health education, including nutrition programs. The COVID-19 pandemic disrupted the education sector, forcing schools to modify standard practices from exclusively in-person delivery to online or blended learning. Digitalized curriculums became particularly useful as an Emergency Remote Teaching tool. This article focuses on developing and implementing a multimedia, multisensory, and scalable Hip-Hop Healthy Eating and Living in Schools (H.E.A.L.S.) Nutrition-Math Curriculum (NMC). NMC comprises 20 lessons-music-based multimedia resources used in the classroom or at home. Fourteen lessons represent self-directed online modules (asynchronous learning) hosted on a Learning Management System (LMS) called "Gooru." The remaining six lessons are teacher-facilitated (in person or using Zoom) review sessions (synchronous learning). The article discusses (1) the development of NMC through the lens of the Multisensory Multilevel Health Education Model (MMHEM), (2) the high acceptability of NMC evaluated using a mixed-methods design among minoritized fifth-grade students attending an after-school program, and (3) the students' completion and mastery rates of the NMC modules based on LMS data. Multimedia nutrition education programs integrated with common core curriculum content, such as NMC, may be a promising avenue for disseminating health education to minoritized children living in New York City and similar high fast-food density cities.

Measures of Aging Biology in Saliva and Blood as Novel Biomarkers for Stroke and Heart Disease in Older Adults.

BACKGROUND AND OBJECTIVES: The role of aging biology as a novel risk factor and biomarker for vascular outcomes in different accessible body tissues such as saliva and blood remain unclear. We aimed to (1) assess the role of aging biology as a risk factor of stroke and heart disease among individuals of same chronologic age and sex and (2) compare aging biology biomarkers measured in different accessible body tissues as novel biomarkers for stroke and heart disease in older adults. METHODS: This study included individuals who consented for blood and saliva draw in the Venous Blood Substudy and Telomere Length Study of the Health and Retirement Study (HRS). The HRS is a population-based, nationally representative longitudinal survey of individuals aged 50 years and older in the United States. Saliva-based measures included telomere length. Blood-based measures included DNA methylation and physiology biomarkers. Propensity scores-matched analyses and Cox regression models were conducted. RESULTS: This study included individuals aged 50 years and older, who consented for blood (N = 9,934) and saliva (N = 5,808) draw in the HRS. Blood-based biomarkers of aging biology showed strong associations with incident stroke as follows: compared with the lowest tertile of blood-based biomarkers of aging, biologically older individuals had significantly higher risk of stroke based on DNA methylation Grim Age clock (adjusted hazard ratio [aHR] = 2.64, 95% CI 1.90-3.66, p < 0.001) and Physiology-based Phenotypic Age clock (aHR = 1.75, 95% CI 1.27-2.42, p < 0.001). In secondary analysis, biologically older individuals had increased risk of heart disease as follows: DNA methylation Grim Age clock (aHR = 1.77, 95% CI 1.49-2.11, p < 0.001) and Physiology-based Phenotypic Age clock (aHR = 1.61, 95% CI 1.36-1.90, p < 0.001). DISCUSSION: Compared with saliva-based telomere length, blood-based aging physiology and some DNA methylation biomarkers are strongly associated with vascular disorders including stroke and are more precise and sensitive biomarkers of aging. Saliva-based telomere length and blood-based DNA methylation and physiology biomarkers likely represent different aspects of biological aging and accordingly vary in their precision as novel biomarkers for optimal vascular health.

Alzheimer Disease: A Life-Limiting Disease With a Burden of a Terminal Illness.

Purpose of Review: An estimated 6.5 million Americans live with Alzheimer dementia. Better understanding of advanced stages of Alzheimer disease (AD) and timely monitoring of its preventable complications would translate to improved survival and quality of life in this population. Recent Findings: In this perspective review, we proposed shifting the narrative to recognizing AD as a chronic life-limiting illness instead of a terminal disease. In support of this view, we discussed the following: (1) the biochemical, cellular (preclinical), and clinical phases of AD; (2) survival after AD; (3) AD therapeutics and potential implications for the population with AD in the advanced stages. Summary: On the bases of the prolonged preclinical phase in AD, promising advances in AD therapeutics and the varying survival after AD, we proposed a new classification for AD and more broadly neurodegenerative disorders to be recognized as chronic life-limiting illnesses rather than terminal diseases with important implications for patients with AD in the advanced stages given the challenges that are specific to this population.

Cardiovascular Disease and Stroke-Focused Competency Assessment Tools for Community Health Workers in the United States: A Scoping Review.

Cardiovascular disease (CVD) and stroke are major contributors to chronic disease burden in the United States. Despite the high prevalence of stroke, 90% of all stroke events are preventable and can be attributed to seven key modifiable risk factors (MRFs)-high blood pressure (BP), high cholesterol, diabetes mellitus (DM), smoking, obesity, unhealthy diet, and physical inactivity. In the United States, stroke prevention interventions led by community health workers (CHWs) have been proven to be highly effective in preventing the onset of MRFs. We conducted a scoping review of the competency assessment methods used in CVD and stroke-focused CHW training programs. We searched six online databases: PubMed, Cochrane, CINAHL, Embase, Web of Science, and HaPI, from all available years until January 2021. Of the 1,774 initial articles found, we identified 30 eligible articles to be included in the review. Nine of these studies used previously validated instruments, whereas the remaining 21 studies used tools from the training curriculum or independently developed instruments. Only five of these validated tools reported psychometric properties; none of them were designed for the CHW population. Our scoping review of literature revealed that CHW-specific competency assessment methods were limited, with few or no domain-referenced tools on CVD or stroke risk factors that complied with established measurement standards. We conclude that there is an urgent need for the development of a comprehensive and valid assessment instrument in CVD and stroke prevention to evaluate CHW performance and optimize their credibility, representing important first steps toward integrating CHWs into health care systems.

Allostatic load predicts racial disparities in intracerebral hemorrhage cognitive outcomes.

A large portion of stroke disparities remains unexplained, even after adjusting for demographic, comorbidity, and health care access variables. There is a critical need to close this knowledge gap by investigating novel factors that may contribute to stroke disparities. Allostatic load (AL) is the lifetime adverse physiologic impact of needing to adjust to socially structured stressors such as racism. AL has been shown to increase health vulnerability and worsen outcomes in marginalized populations. We sought to assess the differential impact of AL on cognitive outcomes post intracerebral hemorrhage (ICH) across race-ethnicity. The Intracerebral Hemorrhage Outcomes Project (ICHOP) prospectively collected data from patients presenting to Columbia Medical Center with ICH from 3/2009 to 5/2016. Data included demographics, stroke scores, labs, complications, neuroimaging, medical history, and discharge data. Five markers of AL (HbA1c, WBC, SBP, HR, ALB) were obtained. An AL score was generated by summing the elements in each patient that fell outside normal ranges, with AL score ranging 0-5. A linear regression model, adjusted for stroke severity and ICH volumes, was used to evaluate the relationship between AL and Modified Telephone Interview for Cognitive Status (TICS-m) at discharge, stratified by race-ethnicity. Among 248 white, 195 black, and 261 Hispanic ICH patients, neither mean AL nor mean TICS differed by race/ethnicity (p = 0.51, p = 0.79 respectively). In the overall cohort AL did not predict TICS at discharge (Beta -1.0, SE 1.1, p = 0.353). In Whites (beta 1.18, SE 2.5, p = 0.646) and Hispanics (beta -0.95, SE 1.6, p = 0.552) AL was not associated with TICS at discharge. In Black patients, higher AL was associated with a decrease in TICS at discharge (beta -3.2, SE 1.5, p = 0.049). AL is an important determinant of post ICH outcomes for certain minority populations. AL may explain some of the unexplained health disparities in stroke populations.

Telehealth After Stroke Care Pilot Randomized Trial of Home Blood Pressure Telemonitoring in an Underserved Setting.

BACKGROUND: Hypertension is the most important modifiable stroke risk factor, but blood pressure (BP) remains poorly controlled after stroke, especially among Black and Hispanic patients. We tested the feasibility of TASC (Telehealth After Stroke Care), a post-acute stroke care model integrating nurse-supported home BP telemonitoring, tailored infographics, and multidisciplinary team video visits. METHODS: Acute stroke patients with hypertension were randomized at discharge to usual care or usual care with TASC. Usual care patients received video visits with primary care and stroke. TASC included a tablet and monitor to wirelessly transmit BP data to the electronic health record, with telenursing support, tailored infographics to explain BP readings, and pharmacist visits. Outcomes assessment was blinded. Feasibility outcomes included recruitment, randomization, adherence, and retention. Systolic BP from baseline to 3 months after discharge was evaluated using generalized linear modeling. RESULTS: Fifty patients (64±14 years; 36% women' 44% Hispanic, 32% Black, 54% ≤high school education, 30% private insurance), and 75% of all eligible were enrolled over 6.3 months. Baseline systolic BP was similar in both (TASC n=25, 140±19 mm Hg; usual care n=25, 142±19 mm Hg). At 3 months, adherence to video visits (91% versus 75%, P=0.14) and retention (84% versus 64%, P=0.11) were higher with TASC. Home systolic BP declined by 16±19 mm Hg from baseline in TASC and increased by 3±24 mm Hg in usual care (P=0.01). Among Black patients, systolic BP control (<130 mm Hg) improved from 40% to 100% with TASC versus 14% to 29%, and among Hispanic patients, from 23% to 62% with TASC, versus 33% to 17% in usual care. CONCLUSIONS: Enhancing post-acute stroke care with home BP telemonitoring is feasible to improve hypertension in an underserved setting and should be tested in a definitive randomized clinical trial. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04640519.

Assessing descriptions of scalability for hypertension control interventions implemented in low-and middle-income countries: A systematic review.

BACKGROUND: The prevalence of hypertension continues to rise in low- and middle-income- countries (LMICs) where scalable, evidence-based interventions (EBIs) that are designed to reduce morbidity and mortality attributed to hypertension have yet to be fully adopted or disseminated. We sought to evaluate evidence from published randomized controlled trials using EBIs for hypertension control implemented in LMICs, and identify the WHO/ExpandNet scale-up components that are relevant for consideration during "scale-up" implementation planning. METHODS: Systematic review of RCTs reporting EBIs for hypertension control implemented in LMICs that stated "scale-up" or a variation of scale-up; using the following data sources PubMed/Medline, Web of Science Biosis Citation Index (BCI), CINAHL, EMBASE, Global Health, Google Scholar, PsycINFO; the grey literature and clinicaltrials.gov from inception through June 2021 without any restrictions on publication date. Two reviewers independently assessed studies for inclusion, conducted data extraction using the WHO/ExpandNet Scale-up components as a guide and assessed the risk of bias using the Cochrane risk-of-bias tool. We provide intervention characteristics for each EBI, BP results, and other relevant scale-up descriptions. MAIN RESULTS: Thirty-one RCTs were identified and reviewed. Studies reported clinically significant differences in BP, with 23 studies reporting statistically significant mean differences in BP (p < .05) following implementation. Only six studies provided descriptions that captured all of the nine WHO/ExpandNet components. Multi-component interventions, including drug therapy and health education, provided the most benefit to participants. The studies were yet to be scaled and we observed limited reporting on translation of the interventions into existing institutional policy (n = 11), cost-effectiveness analyses (n = 2), and sustainability measurements (n = 3). CONCLUSION: This study highlights the limited data on intervention scalability for hypertension control in LMICs and demonstrates the need for better scale-up metrics and processes for this setting. TRIAL REGISTRATION: Registration PROSPERO (CRD42019117750).

Individual and Joint Effects of Influenza-Like Illness and Vaccinations on Stroke in the Young: A Case-Control Study.

BACKGROUND: Influenza-like illness (ILI) is an acute trigger for stroke, although joint effects of vaccinations and ILI have not yet been explored. METHODS: Data for our case-control study was obtained from MarketScan Commercial Claims and Encounters between 2008 and 2014. Patients 18 to 65 years old who experienced a stroke were matched on age and admission date to a control, defined as patients with head trauma or ankle sprain at an inpatient or emergency department visit. Exposures were ILI in the prior 30 days, and any type of vaccination during the year prior. Our outcome was ischemic and intracerebral hemorrhagic strokes identified using International Classification of Diseases, Ninth Revision (ICD-9) codes. Logistic regression models estimated adjusted odds ratios (aORs) controlling for preventive care visits, diabetes, valvular heart disease, smoking, alcohol abuse, obesity, and hypertension. RESULTS: We identified and matched 24 103 cases 18 to 44 years old and 141 811 45 to 65 years old. Those aged 18 to 44 years had increased stroke risk 30 days after ILI (aOR, 1.68 [95% CI, 1.51-1.86]) and reduced risk with any vaccination in the year prior (aOR, 0.92 [95% CI, 0.87-0.99]). Joint effects indicate that ILI was associated with increased stroke risk among those with (aOR, 1.41 [95% CI, 1.08-1.85]) and without (aOR, 1.73 [95% CI, 1.55-1.94]) vaccinations in the prior year (Pinteraction=0.16). Among those aged 45 to 65 years, adjusted analyses indicate increased stroke risk for those with ILI (aOR, 1.32 [95% CI, 1.26-1.38]), although there was no effect of vaccinations (aOR, 1.00 [95% CI, 0.97-1.02]). Joint effects indicate that ILI was not associated with stroke among those with any vaccination (aOR, 1.07 [95% CI, 0.96-1.18]) but was associated with increased risk among those without vaccinations ([aOR, 1.39 [95% CI, 1.32-1.47]; Pinteraction<0.001). CONCLUSIONS: ILI was associated with increased stroke risk in the young and middle-aged, while vaccinations of any type were associated with decreased risk among the young. Joint effects of ILI and vaccinations indicate vaccinations can reduce the effect of ILI on stroke.

TASC (Telehealth After Stroke Care): a study protocol for a randomized controlled feasibility trial of telehealth-enabled multidisciplinary stroke care in an underserved urban setting.

BACKGROUND: Hypertension is the most important modifiable risk factor for recurrent stroke, and blood pressure (BP) reduction is associated with decreased risk of stroke recurrence. However, hypertension remains poorly controlled in many stroke survivors. Black and Hispanic patients have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access to care contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) is a telehealth intervention that integrates remote BP monitoring (RBPM) including nursing telephone support, tailored BP infographics and telehealth video visits with a multidisciplinary team approach including pharmacy to improve post-stroke care and reduce stroke disparities. METHODS: In this pilot trial, 50 acute stroke patients with hypertension will be screened for inclusion prior to hospital discharge and randomized to usual care or TASC. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. In addition to these usual care visits, TASC intervention patients will see a pharmacist at 4 and 8 weeks and will be enrolled in RBPM consisting of home BP monitoring with interval calls by a centralized team of telehealth nurses. As part of RBPM, TASC patients will be provided with a home BP monitoring device and electronic tablet that wirelessly transmits home BP data to the electronic health record. They will also receive tailored BP infographics that help explain their BP readings. The primary outcome will be feasibility including recruitment, adherence to at least one video visit and retention rates. The clinical outcome for consideration in a subsequent trial will be within-patient change in BP from baseline to 3 months after discharge. Secondary outcomes will be medication adherence self-efficacy and satisfaction with post-stroke telehealth, both measured at 3 months. Additional patient reported outcomes will include depression, cognitive function, and socioeconomic determinants. Multidisciplinary team competency and fidelity measures will also be assessed. CONCLUSIONS: Integrated team-based interventions may improve BP control and reduce racial/ethnic disparities in post-stroke care. TASC is a post-acute stroke care model that is novel in providing RBPM with tailored infographics, and a multidisciplinary team approach including pharmacy. Our pilot will determine if such an approach is feasible and effective in enhancing post-stroke BP control and promoting self-efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04640519.

Study protocol for comparing Screening, Brief Intervention, and Referral to Treatment (SBIRT) to referral as usual for depression in African American churches.

BACKGROUND: Depression is a leading cause of disability worldwide. African American adults, compared to White adults, are half as likely to be screened for depression in primary care settings. Disparities in depression screening contribute to poor clinical outcomes, as African Americans with depression are more disabled and sicker longer compared to Whites. African American churches are trusted settings that provide access to supports for depression. Indeed, in the first study of its kind, the investigators found that 20% of adults in African American churches screened positive for depression using the Patient Health Questionnaire-9 (PHQ-9). However, no subjects with a positive screen (PHQ-9 ≥ 10) accepted a treatment referral when offered by research personnel. Community Health Workers, who are trusted paraprofessionals from the target community, may bridge the gap between depression screening and treatment. The investigators have trained and certified 112 Community Health Workers from 45 African American churches in New York City to deliver an evidence-based intervention called Screening, Brief Intervention, and Referral to Treatment (SBIRT). Thus, the aim of the current study is to test the impact of Community Health Worker-delivered depression screening in Black churches on engagement with clinical services. METHODS: Using a hybrid type 1 effectiveness-implementation design, we propose a 2-arm, mixed-methods cluster randomized controlled trial. Church study sites will be randomized to either SBIRT (intervention arm) or referral as usual (usual care arm). This trial will be conducted with 600 church members across 30 churches (300 intervention; 300 usual care). Our primary outcome is treatment engagement, defined as attending a depression-related clinical visit. Secondary outcomes will be changes in Mental Health-Related Quality of Life and depressive symptoms at 3 and 6 months post-screening. Lastly, we will conduct a concurrent, mixed-methods (qualitative-quantitative) process evaluation to assess contextual facilitators and barriers of screening and referral. DISCUSSION: This is the first randomized trial of a church-placed, community health worker-delivered intervention for depression in African American populations. This study may provide a novel and effective approach to increasing depression identification and treatment linkage in economically disadvantaged populations with high depression rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT04524767 . Registered on 21 August 2020.

Feasibility of deploying peer coaches to mentor frontline home health aides and promote mobility among individuals recovering from a stroke: pilot test of a randomized controlled trial.

BACKGROUND: Each year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as "peer coaches" to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures. METHODS: This was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures. RESULTS: Achieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants. CONCLUSIONS: The trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04840407 . Retrospectively registered on 9 April 2021.

Self-Reported Race as a Social Determinant of Stroke Risk in Observational Versus Clinical Trial Datasets.

OBJECTIVES: Self-reported Black (SRB) Americans are approximately twice as likely to have a stroke as self-reported White (SRW) Americans. While social determinants of health and vascular risk factors account for some of the disparity, half the increased risk remains unexplained and may be related to unmeasured real-world factors of the racialized experience. MATERIALS: and Methods In this cohort study, we compared SRB and SRW participants in the Systolic Blood Pressure Intervention Trial (SPRINT) to the same groups in the observational Atherosclerosis Risk in Communities (ARIC) study to evaluate if clinical trial participation mitigates disparities in stroke risk. We set the ARIC baseline at visit 4 and excluded participants with prior stroke to create an ARIC cohort similar in age to SPRINT participants. The study outcome was incident primary stroke. We report hazard ratios from Cox models and inverse-probability weighted Cox models with propensity score matching on participant age, sex, diabetes, atrial fibrillation, and smoking. RESULTS: We included 10,094 patients from ARIC and 8,869 from SPRINT, of which 26.1% were SRB. The risk of stroke between SRW participants in SPRINT versus ARIC was not significantly different (IPW-Weighted HR 0.78 [0.52-1.19]). SRB ARIC participants were twice as likely to have a stroke as SRW ARIC participants (IPW-Weighted HR = 1.96 [1.41-2.71]). However, SRB SPRINT participants did not have higher stroke risk compared to SRW SPRINT or ARIC participants (IPW-Weighted HR 0.99 [0.68--1.77] and 0.95 [.57-1.59], respectively). SRB SPRINT participants in the intensive BP control group had a lower risk of stroke compared to SRB ARIC participants (IPW-Weighted HR = 0.39 [0.20-0.75]). CONCLUSIONS: SRB race, compared to SRW race, is associated with an increase in primary stroke risk in the ARIC study but not in the SPRINT trial. The absence of the racial disparity in stroke incidence in SPRINT indicates that aspects of the disparity are modifiable. Population-based interventions that test this hypothesis deserve further attention.

Cilostazol for Secondary Stroke Prevention: History, Evidence, Limitations, and Possibilities.

Cilostazol is a PDE3 (phosphodiesterase III) inhibitor with a long track record of safety that is Food and Drug Administration and European Medicines Agency approved for the treatment of claudication in patients with peripheral arterial disease. In addition, cilostazol has been approved for secondary stroke prevention in several Asian countries based on trials that have demonstrated a reduction in stroke recurrence among patients with noncardioembolic stroke. The onset of benefit appears after 60 to 90 days of treatment, which is consistent with cilostazol's pleiotropic effects on platelet aggregation, vascular remodeling, blood flow, and plasma lipids. Cilostazol appears safe and does not increase the risk of major bleeding when given alone or in combination with aspirin or clopidogrel. Adverse effects such as headache, gastrointestinal symptoms, and palpitations, however, contributed to a 6% increase in drug discontinuation among patients randomized to cilostazol in a large secondary stroke prevention trial (CSPS.com [Cilostazol Stroke Prevention Study for Antiplatelet Combination]). Due to limitations of prior trials, such as open-label design, premature trial termination, large loss to follow-up, lack of functional or cognitive outcome data, and exclusive enrollment in Asia, the existing trials have not led to a change in clinical practice or guidelines in Western countries. These limitations could be addressed by a double-blind placebo-controlled randomized trial conducted in a broader population. If positive, it would increase the evidence in support of long-term treatment with cilostazol for secondary prevention in the millions of patients worldwide who have experienced a noncardioembolic ischemic stroke.