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Background Stroke is a leading cause of adult disability and mortality. Intravenous thrombolysis can minimize disability when patients present to the emergency department for treatment within the 3 − 4½ h of symptom onset. Blacks and Hispanics are more likely to die and suffer disability from stroke than whites, due in part to delayed hospital arrival and ineligibility for intravenous thrombolysis for acute stroke. Low stroke literacy (poor knowledge of stroke symptoms and when to call 911) among Blacks and Hispanics compared to whites may contribute to disparities in acute stroke treatment and outcomes. Improving stroke literacy may be a critical step along the pathway to reducing stroke disparities. The aim of the current study is to test a novel intervention to increase stroke literacy in minority populations in New York City. Design and Methods In a two-arm cluster randomized trial, we will evaluate the effectiveness of two culturally tailored stroke education films – one in English and one in Spanish – on changing behavioral intent to call 911 for suspected stroke, compared to usual care. These films will target knowledge of stroke symptoms, the range of severity of symptoms and the therapeutic benefit of calling 911, as well as address barriers to timely presentation to the hospital. Given the success of previous church-based programs targeting behavior change in minority populations, this trial will be conducted with 250 congregants across 14 churches (125 intervention; 125 control). Our proposed outcomes are (1) recognition of stroke symptoms and (2) behavioral intent to call 911 for suspected stroke, measured using the Stroke Action Test at the 6-month and 1-year follow-up. Discussion This is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one church in almost every neighborhood in the USA, churches have the ability and reach to play an important role in the dissemination and translation of stroke prevention programs in minority communities. Trial registration NCT01909271; July 22, 2013

Background Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. Methods/Design This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion. Discussion This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice. Trial Registration Clinicaltrials.gov NCT01070056

Background Racial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management. Methods/Design This 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC + NP) or UHC complemented by an NP plus health coach (UHC + NP + HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients’/caregivers’ ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient’s reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP + HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment. Discussion This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes. Trial registration ClinicalTrials.gov NCT01918891; Registered 5 August 2013.

Background Black and Hispanic stroke survivors experience higher rates of recurrent stroke than whites. This disparity is partly explained by disproportionately higher rates of uncontrolled hypertension in these populations. Home blood pressure telemonitoring (HBPTM) and nurse case management (NCM) have proven efficacy in addressing the multilevel barriers to blood pressure (BP) control and reducing BP. However, the effectiveness of these interventions has not been evaluated in stroke patients. This study is designed to evaluate the comparative effectiveness, cost-effectiveness and sustainability of these two telehealth interventions in reducing BP and recurrent stroke among high-risk Black and Hispanic stroke survivors with uncontrolled hypertension. Methods/Design A total of 450 Black and Hispanic patients with recent nondisabling stroke and uncontrolled hypertension are randomly assigned to one of two 12-month interventions: 1) HBPTM with wireless feedback to primary care providers or 2) HBPTM plus individualized, culturally-tailored, telephone-based NCM. Patients are recruited from stroke centers and primary care practices within the Health and Hospital Corporations (HHC) Network in New York City. Study visits occur at baseline, 6, 12 and 24 months. The primary outcomes are within-patient change in systolic BP at 12 months, and the rate of stroke recurrence at 24 months. The secondary outcome is the comparative cost-effectiveness of the interventions at 12 and 24 months; and exploratory outcomes include changes in stroke risk factors, health behaviors and treatment intensification. Recruitment for the stroke telemonitoring hypertension trial is currently ongoing. Discussion The combination of two established and effective interventions along with the utilization of health information technology supports the sustainability of the HBPTM + NCM intervention and feasibility of its widespread implementation. Results of this trial will provide strong empirical evidence to inform clinical guidelines for management of stroke in minority stroke survivors with uncontrolled hypertension. If effective among Black and Hispanic stroke survivors, these interventions have the potential to substantially mitigate racial and ethnic disparities in stroke recurrence. Trial registration ClinicalTrials.gov NCT02011685. Registered 10 December 2013.