Stroke in Indigenous Africans, African Americans, and European Americans: Interplay of Racial and Geographic Factors.

BACKGROUND AND PURPOSE: The relative contributions of racial and geographic factors to higher risk of stroke in people of African ancestry have not been unraveled. We compared stroke type and contributions of vascular risk factors among indigenous Africans (IA), African Americans (AA), and European Americans (EA). METHODS: SIREN (Stroke Investigative Research and Educational Network) is a large multinational case-control study in West Africa-the ancestral home of 71% AA-whereas REGARDS (Reasons for Geographic and Racial Differences in Stroke) is a cohort study including AA and EA in the United States. Using harmonized assessments and standard definitions, we compared data on stroke type and established risk factors for stroke in acute stroke cases aged ≥55 years in both studies. RESULTS: There were 811 IA, 452 AA, and 665 EA stroke subjects, with mean age of 68.0±9.3, 73.0±8.3, and 76.0±8.3 years, respectively (P<0.0001). Hemorrhagic stroke was more frequent among IA (27%) compared with AA (8%) and EA (5.4%; P<0.001). Lacunar strokes were more prevalent in IA (47.1%), followed by AA (35.1%) and then EA (21.0%; P<0.0001). The frequency of hypertension in decreasing order was IA (92.8%), followed by AA (82.5%) and then EA (64.2%; P<0.0001) and similarly for diabetes mellitus IA (38.3%), AA (36.8%), and EA (21.0%; P<0.0001). Premorbid sedentary lifestyle was similar in AA (37.7%) and EA (34.0%) but lower frequency in IA (8.0%). CONCLUSIONS: Environmental risk factors such as sedentary lifestyle may contribute to the higher proportion of ischemic stroke in AA compared with IA, whereas racial factors may contribute to the higher proportion of hypertension and diabetes mellitus among stroke subjects of African ancestry.

Prevalence and Predictors of Sleep Apnea Risk among Ghanaian Stroke Survivors.

BACKGROUND AND PURPOSE: Sleep apnea (SA) has emerged as a potent risk factor for stroke recurrence and mortality. The burden of SA among stroke survivors in sub-Saharan Africa where stroke incidence and mortality are escalating is unknown. We sought to assess the prevalence of SA risk and its clinical correlates and predictors among Ghanaian stroke survivors. METHODS: This cross-sectional study involved 200 consecutive stroke survivors attending a neurology clinic in a tertiary medical center in Kumasi, Ghana. The validated Berlin, STOP-BANG, and Epworth Sleepiness Scale questionnaires were administered to all eligible subjects to assess SA risk and daytime somnolence, and their demographic and clinical information, health-related quality of life, and symptoms of depression were collected using the questionnaires. RESULTS: The median (interquartile range) age of stroke survivors was 62 (52-72) years and 52.5% were male. Ninety-nine (49.5%) subjects were identified as high risk for SA using the Berlin questionnaire, whereas 26 (13%), 137 (68.5%), and 37 (18.5%) subjects were classified as low, intermediate, and high risk for SA, respectively, using the STOP-BANG questionnaire. Patients at high risk of SA were significantly older, used excess alcohol, and were less able to perform activities of daily living, although their mean National Institutes of Health Stroke Scale scores were significantly lower than those with low risk for SA. None of the stroke survivors had ever been screened for SA. CONCLUSIONS: One out of every 2 stroke survivors attending a neurology clinic in Ghana is at high risk for undiagnosed SA. Greater regional awareness about SA presence and outcomes among patients and providers is warranted.

Development and Reliability of a User-Friendly Multicenter Phenotyping Application for Hemorrhagic and Ischemic Stroke.

BACKGROUND: Annotation and Image Markup on ClearCanvas Enriched Stroke-phenotyping Software (ACCESS) is a novel stand-alone computer software application that allows the creation of simple standardized annotations for reporting brain images of all stroke types. We developed the ACCESS application and determined its inter-rater and intra-rater reliability in the Stroke Investigative Research and Educational Network (SIREN) study to assess its suitability for multicenter studies. METHODS: One hundred randomly selected stroke imaging reports from 5 SIREN sites were re-evaluated by 4 trained independent raters to determine the inter-rater reliability of the ACCESS (version 12.0) software for stroke phenotyping. To determine intra-rater reliability, 6 raters reviewed the same cases previously reported by them after a month of interval. Ischemic stroke was classified using the Oxfordshire Community Stroke Project (OCSP), Trial of Org 10172 in Acute Stroke Treatment (TOAST), and Atherosclerosis, Small-vessel disease, Cardiac source, Other cause (ASCO) protocols, while hemorrhagic stroke was classified using the Structural lesion, Medication, Amyloid angiopathy, Systemic disease, Hypertensive angiopathy and Undetermined (SMASH-U) protocol in ACCESS. Agreement among raters was measured with Cohen's kappa statistics. RESULTS: For primary stroke type, inter-rater agreement was .98 (95% confidence interval [CI], .94-1.00), while intra-rater agreement was 1.00 (95% CI, 1.00). For OCSP subtypes, inter-rater agreement was .97 (95% CI, .92-1.00) for the partial anterior circulation infarcts, .92 (95% CI, .76-1.00) for the total anterior circulation infarcts, and excellent for both lacunar infarcts and posterior circulation infarcts. Intra-rater agreement was .97 (.90-1.00), while inter-rater agreement was .93 (95% CI, .84-1.00) for TOAST subtypes. Inter-rater agreement ranged between .78 (cardioembolic) and .91 (large artery atherosclerotic) for ASCO subtypes and was .80 (95% CI, .56-1.00) for SMASH-U subtypes. CONCLUSION: The ACCESS application facilitates a concordant and reproducible classification of stroke subtypes by multiple investigators, making it suitable for clinical use and multicenter research.

Multilingual Validation of the Questionnaire for Verifying Stroke-Free Status in West Africa.

BACKGROUND AND PURPOSE: The Questionnaire for Verifying Stroke-Free Status (QVSFS), a method for verifying stroke-free status in participants of clinical, epidemiological, and genetic studies, has not been validated in low-income settings where populations have limited knowledge of stroke symptoms. We aimed to validate QVSFS in 3 languages, Yoruba, Hausa and Akan, for ascertainment of stroke-free status of control subjects enrolled in an on-going stroke epidemiological study in West Africa. METHODS: Data were collected using a cross-sectional study design where 384 participants were consecutively recruited from neurology and general medicine clinics of 5 tertiary referral hospitals in Nigeria and Ghana. Ascertainment of stroke status was by neurologists using structured neurological examination, review of case records, and neuroimaging (gold standard). Relative performance of QVSFS without and with pictures of stroke symptoms (pictograms) was assessed using sensitivity, specificity, positive predictive value, and negative predictive value. RESULTS: The overall median age of the study participants was 54 years and 48.4% were males. Of 165 stroke cases identified by gold standard, 98% were determined to have had stroke, whereas of 219 without stroke 87% were determined to be stroke-free by QVSFS. Negative predictive value of the QVSFS across the 3 languages was 0.97 (range, 0.93-1.00), sensitivity, specificity, and positive predictive value were 0.98, 0.82, and 0.80, respectively. Agreement between the questionnaire with and without the pictogram was excellent/strong with Cohen k=0.92. CONCLUSIONS: QVSFS is a valid tool for verifying stroke-free status across culturally diverse populations in West Africa.

Development and preliminary evaluation of a behavioural HIV-prevention programme for teenage girls of Latino descent in the USA.

National data suggests that teenage girls of Latino descent in the USA are disproportionately affected by HIV, with the US Centers for Disease Control and Prevention reporting the rate of new infections being approximately four times higher compared to White women of comparable age . This paper highlights the need for an effective single-sex HIV-prevention programme for teenage girls of Latino descent and describes the development and preliminary evaluation of Chicas Healing, Informing, Living and Empowering (CHILE), a culturally-tailored, HIV-prevention programme exclusively for teenage girls of Latino descent that was adapted from Sisters Informing, Healing, Living and Empowering (SiHLE), an evidence-based HIV- prevention program that is culturally tailored for African American young women. Theatre testing, a pre-testing methodology to assess consumer response to a demonstration of a product, was utilised to evaluate the relevance and utility of the HIV programme as well as opportunities for the integration of cultural constructs. Future directions for the evaluation of CHILE are discussed.

Erratum to stroke patients and their attitudes toward mHealth monitoring to support blood pressure control and medication adherence.

[This corrects the article DOI: 10.21037/mhealth.2016.05.04.].

Knowledge, attitudes and practices of West Africans on genetic studies of stroke: Evidence from the SIREN Study.

BACKGROUND: It is crucial to assess genomic literacy related to stroke among Africans in preparation for the ethical, legal and societal implications of the genetic revolution which has begun in Africa. OBJECTIVE: To assess the knowledge, attitudes and practices (KAP) of West Africans about stroke genetic studies. METHODS: A comparative cross-sectional study was conducted among stroke patients and stroke-free controls recruited across 15 sites in Ghana and Nigeria. Participants' knowledge of heritability of stroke, willingness to undergo genetic testing and perception of the potential benefits of stroke genetic research were assessed using interviewer-administered questionnaire. Descriptive, frequency distribution and multiple regression analyses were performed. RESULTS: Only 49% of 2029 stroke patients and 57% of 2603 stroke-free individuals knew that stroke was a heritable disorder. Among those who knew, 90% were willing to undergo genetic testing. Knowledge of stroke heritability was associated with having at least post-secondary education (OR 1.51, 1.25-1.81) and a family history of stroke (OR 1.20, 1.03-1.39) while Islamic religion (OR=0.82, CI: 0.72-0.94), being currently unmarried (OR = 0.81, CI: 0.70-0.92), and alcohol use (OR = 0.78, CI: 0.67-0.91) were associated with lower odds of awareness of stroke as a heritable disorder. Willingness to undergo genetic testing for stroke was associated with having a family history of stroke (OR 1.34, 1.03-1.74) but inversely associated with a medical history of high blood pressure (OR = 0.79, 0.65-0.96). CONCLUSION: To further improve knowledge of stroke heritability and willingness to embrace genetic testing for stroke, individuals with less formal education, history of high blood pressure and no family history of stroke require targeted interventions.

Post-stroke depression in Ghana: Characteristics and correlates.

BACKGROUND: Poststroke depression (PSD) is prevalent and is an important determinant of functional recovery, quality of life and mortality after stroke. Scanty data on the nature of PSD among stroke survivors in sub-Saharan Africa prompted this study. OBJECTIVE: To assess the prevalence and predictors of depression in a convenience sample of Ghanaian stroke survivors. METHODS: We evaluated consecutive stroke survivors encountered at a comprehensive neurology clinic in a tertiary medical center in Ghana. The Center for Epidemiologic Studies Depression Scale (CES-D) and Geriatric Depression Scale (GDS) were both used to screen for depressive symptoms and subjects were considered as depressed if they scored ≥16 on the CES-D scale and >5 on the GDS. Demographic and clinical data on stroke type and severity as well as health-related quality of life indicators were collected. Predictors of stroke-related depression were assessed using a logistic regression model. RESULTS: Of 200 stroke survivors, mean±SD age was 62.0±14.4years, and 105 (52.5%) patients were men. Among the cohort 78.5% were classified as being depressed by CES-D, 42.5% by GDS, and 36.5% on both CES-D and GDS. In multivariable analyses, for each unit increase on the Modified Rankin scale (i.e. worsening disability), there were higher odds of depression (adjusted OR 1.85; 1.28-2.69, p=0.001), and being divorced (vs. being married) was linked to depression (adjusted 2.82; 1.18-6.71, p=0.02). Stroke survivors with depression demonstrated profound diminutions in the physical, psycho-social, cognitive and eco-social domains of quality of life compared with those without depression (p<0.05). CONCLUSION: Almost 4 out of 10 stroke survivors in this Ghanaian cohort displayed clinically significant depression. Prospective interventional studies are urgently needed to provide solid evidence-based and culturally tailored interventions to address post-stroke depression particularly in LMICs.

Stroke-related stigma among West Africans: Patterns and predictors.

BACKGROUND: Disability-adjusted life-years lost after stroke in Low & Middle-Income Countries (LMICs) is almost seven times those lost in High-income countries. Although individuals living with chronic neurological and mental disorders are prone to stigma, there is a striking paucity of literature on stroke-related stigma particularly from LMICs. OBJECTIVE: To assess the prevalence, severity, determinants and psycho-social consequences of stigma among LMIC stroke survivors. METHODS: Between November 2015 and February 2016, we conducted a cross-sectional survey of 200 consecutive stroke survivors attending a neurology clinic in a tertiary medical center in Ghana. The validated 8-Item Stigma Scale for Chronic Illness (SSCI-8) questionnaire was administered to study participants to assess internalized and enacted domains of stigma at the personal dimension with further adaptation to capture family and community stigma experienced by stroke participants. Responses on the SSCI-8 were scored from 1 to 5 for each item, where 1=never, 2=rarely, 3=sometimes, 4=often and 5=always with a score range of 8-40. Demographic and clinical data on stroke type and severity as well as depression and Health-Related Quality of Life indicators were also collected. Predictors of stroke-related stigma were assessed using Linear Models (GLM) via Proc GENMOD in SAS 9.4. RESULTS: 105 (52.5%) subjects recruited were males and the mean±SD age of stroke survivors in this survey was 62.0±14.4years. Mean SSCI-8 score was highest for personal stigma (13.7±5.7), which was significantly higher than family stigma (11.9±4.6; p=0.0005) and social/community stigma (11.4±4.4; p<0.0001). Approximately 80% of the cohort reported experiencing mild-to-moderate degrees of stigma. A graded increase in scores on the Geriatric Depression Scale and Centre for Epidemiological Studies-Depression scale was observed across the three categories. Living in an urban setting was associated with higher SSCI-8 scores. Moreover, stroke subjects with more severe post-stroke residual symptom deficits reported a significantly higher frequency of stigma. CONCLUSION: Four out of five stroke survivors in this Ghanaian cohort reported experiencing some form of stigma. Stigmatized individuals were also more likely to be depressed and have lower levels of quality of life. Further studies are required to assess the consequences of stigma from stroke in LMIC.

Short-term pilot feasibility study of a nurse-led intervention to improve blood pressure control after stroke in Nigeria.

BACKGROUND: Given the paucity of neurologists in Sub-Saharan Africa (SSA), task-shifting post-stroke care to nurses could be a viable avenue for enhancing post-stroke outcomes. This pilot study assessed the feasibility and short-term impact of a nurse-led intervention to manage blood pressure (BP) control in recent stroke survivors in Nigeria. METHODS: A randomized pilot trial allocated patients within one month of an index stroke from two participating hospitals in Nigeria to either nurse-led group clinic or standard care for 14days. Key study endpoints were successful execution of the protocol, subject retention, and short-term BP effects. RESULTS: There were no significant differences between the intervention (n=17) and control (n=18) groups at baseline. At the post-intervention clinic, patient retention rate was 100%. In the intervention group, both the systolic and diastolic BPs measured at home were lower than the clinic BPs post-intervention (127±12.88/78.13±19.26mmHg versus 137.50±23.05/84.06±9.67mmHg; p=0.05). However, there was no significant change in clinic blood pressure (BP) recordings in both the intervention and control groups. CONCLUSION: It is possible to initiate a nurse-led group clinic intervention to address BP management among stroke survivors in SSA with good early retention of participants. A larger and longer-term trial is being planned.

Assessing Mobile Health Capacity and Task Shifting Strategies to Improve Hypertension Among Ghanaian Stroke Survivors.

BACKGROUND: There has been a tremendous surge in stroke prevalence in sub-Saharan Africa. Hypertension (HTN), the most potent, modifiable risk factor for stroke, is a particular challenge in sub-Saharan Africa. Culturally sensitive, efficacious HTN control programs that are timely and sustainable are needed, especially among stroke survivors. Mobile health (mHealth) technology and task-shifting offer promising approaches to address this need. METHODS: Using a concurrent triangulation design, we collected data from stroke survivors, caregivers, community leaders, clinicians and hospital personnel to explore the barriers, facilitators and perceptions toward mHealth related to HTN management among poststroke survivors in Ghana. Exploration included perceptions of a nurse-led navigational model to facilitate care delivery and willingness of stroke survivors and caregivers to use mHealth technology. RESULTS: Two hundred stroke survivors completed study surveys while focus groups (n = 4) were conducted with stroke survivors, caregivers and community leaders (n = 28). Key informant interviews were completed with clinicians and hospital personnel (n = 10). A total of 93% of survey respondents had HTN (60% uncontrolled). Findings support mHealth strategies for poststroke care delivery and HTN management and for task-shifting through a nurse-led model. Of survey and focus group participants, 76% and 78.6%, respectively, have access to mobile phones and 90% express comfort in using mobile phones and conveyed assurance that task-shifting through a nurse-led model could facilitate management of HTN. Findings also identified barriers to care delivery and medication adherence across all levels of the social ecological model. CONCLUSIONS: Participants strongly supported enhanced care delivery through mobile health and were receptive toward a nurse-led navigational model.

Interleukin-6 (IL-6) rs1800796 and cyclin dependent kinase inhibitor (CDKN2A/CDKN2B) rs2383207 are associated with ischemic stroke in indigenous West African Men.

BACKGROUND: Inherited genetic variations offer a possible explanation for the observed peculiarities of stroke in sub - Saharan African populations. Interleukin-6 polymorphisms have been previously associated with ischemic stroke in some non-African populations. AIM: Herein we investigated, for the first time, the association of genetic polymorphisms of IL-6, CDKN2A- CDKN2B and other genes with ischemic stroke among indigenous West African participants in the Stroke Investigative Research and Education Network (SIREN) Study. METHODS: Twenty-three previously identified single nucleotide polymorphisms (SNPs) in 14 genes of relevance to the neurobiology of ischemic stroke were investigated. Logistic regression models adjusting for known cardiovascular disease risk factors were constructed to assess the associations of the 23 SNPs in rigorously phenotyped cases (N=429) of ischemic stroke (Men=198; Women=231) and stroke- free (N=483) controls (Men=236; Women=247). RESULTS: Interleukin-6 (IL6) rs1800796 (C minor allele; frequency: West Africans=8.6%) was significantly associated with ischemic stroke in men (OR=2.006, 95% CI=[1.065, 3.777], p=0.031) with hypertension in the model but not in women. In addition, rs2383207 in CDKN2A/CDKN2B (minor allele A with frequency: West Africans=1.7%) was also associated with ischemic stroke in men (OR=2.550, 95% CI=[1.027, 6.331], p=0.044) with primary covariates in the model, but not in women. Polymorphisms in other genes did not show significant association with ischemic stroke. CONCLUSION: Polymorphisms rs1800796 in IL6 gene and rs2383207 in CDKN2A/CDKN2B gene have significant associations with ischemic stroke in indigenous West African men. CDKN2A/CDKN2B SNP rs2383207 is independently associated with ischemic stroke in indigenous West African men. Further research should focus on the contributions of inflammatory genes and other genetic polymorphisms, as well as the influence of sex on the neurobiology of stroke in people of African ancestry.

Exploring Overlaps Between the Genomic and Environmental Determinants of LVH and Stroke: A Multicenter Study in West Africa.

BACKGROUND: Whether left ventricular hypertrophy (LVH) is determined by similar genomic and environmental risk factors with stroke, or is simply an intermediate stroke marker, is unknown. OBJECTIVES: We present a research plan and preliminary findings to explore the overlap in the genomic and environmental determinants of LVH and stroke among Africans participating in the SIREN (Stroke Investigative Research and Education Network) study. METHODS: SIREN is a transnational, multicenter study involving acute stroke patients and age-, ethnicity-, and sex-matched control subjects recruited from 9 sites in Ghana and Nigeria. Genomic and environmental risk factors and other relevant phenotypes for stroke and LVH are being collected and compared using standard techniques. RESULTS: This preliminary analysis included only 725 stroke patients (mean age 59.1 ± 13.2 years; 54.3% male). Fifty-five percent of the stroke subjects had LVH with greater proportion among women (51.6% vs. 48.4%; p < 0.001). Those with LVH were younger (57.9 ± 12.8 vs. 60.6 ± 13.4; p = 0.006) and had higher mean systolic and diastolic blood pressure (167.1/99.5 mm Hg vs 151.7/90.6 mm Hg; p < 0.001). Uncontrolled blood pressure at presentation was prevalent in subjects with LVH (76.2% vs. 57.7%; p < 0.001). Significant independent predictors of LVH were age <45 years (adjusted odds ratio [AOR]: 1.91; 95% confidence interval [CI]: 1.14 to 3.19), female sex (AOR: 2.01; 95% CI: 1.44 to 2.81), and diastolic blood pressure > 90 mm Hg (AOR: 2.10; 95% CI: 1.39 to 3.19; p < 0.001). CONCLUSIONS: The prevalence of LVH was high among stroke patients especially the younger ones, suggesting a genetic component to LVH. Hypertension was a major modifiable risk factor for stroke as well as LVH. It is envisaged that the SIREN project will elucidate polygenic overlap (if present) between LVH and stroke among Africans, thereby defining the role of LVH as a putative intermediate cardiovascular phenotype and therapeutic target to inform interventions to reduce stroke risk in populations of African ancestry.

Experience of Using an Interdisciplinary Task Force to Develop a Culturally Sensitive Multipronged Tool to Improve Stroke Outcomes in Nigeria.

The burden of stroke is on the rise in Nigeria. A multi-faceted strategy is essential for reducing this growing burden and includes promoting medication adherence, optimizing traditional biomarker risk targets (blood pressure, cholesterol) and encouraging beneficial lifestyle practices. Successful implementation of this strategy is challenged by inadequate patient health literacy, limited patient/medical system resources, and lack of a coordinated interdisciplinary treatment approach. Moreover, the few interventions developed to improve medical care in Nigeria have generally been aimed at physicians (primarily) and nurses (secondarily) with minimal input from other key health care providers, and limited contributions from patients, caregivers, and the community itself. The Tailored Hospital-based Risk Reduction to Impede Vascular Events after Stroke (THRIVES) study is assessing the efficacy of a culturally sensitive multidimensional intervention for controlling blood pressure in recent stroke survivors. A key component of the intervention development process was the constitution of a project task force comprising various healthcare providers and administrators. This paper describes the unique experience in Sub-Saharan Africa of utilizing of an interdisciplinary Task Force to facilitate the development of the multipronged behavioral intervention aimed at enhancing stroke outcomes in a low-middle income country.

Validation of the 8-item questionnaire for verifying stroke free status with and without pictograms in three West African languages.

BACKGROUND: The Questionnaire for Verifying Stroke-free Status (QVSFS) has been validated in Western populations as a method for verifying stroke-free status in participants of clinical, epidemiological and genetic studies. This instrument has not been validated in low-income settings where populations have limited knowledge of stroke symptoms and literacy levels are low. OBJECTIVE: To simultaneously validate the 8-item QVSFS in 3 languages spoken in West Africa (Yoruba, Hausa and Akan) for ascertainment of stroke-free status of control subjects in SIREN. METHODS: Using a cross-sectional study design, 100 participants each from the 3 linguistic groups will be consecutively recruited from neurology and general medicine clinics of 5 tertiary referral hospitals in Nigeria and Ghana. Ascertainment of stroke status will be determined by neurologists using structured neurological examination, review of case records and neuro-imaging (Gold standard). The relative performance of QVSFS without and with pictures of stroke symptoms (pictograms) will be assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). CONCLUSION: The proposed study will provide valuable data on the performance of the QVSFS in resource-limited settings.

Stroke patients and their attitudes toward mHealth monitoring to support blood pressure control and medication adherence.

BACKGROUND: Mobile health, or mHealth, has increasingly been signaled as an effective means to expedite communication and improve medical regimen adherence, especially for patients with chronic health conditions such as stroke. However, there is a lack of data on attitudes of stroke patients toward mHealth. Such information will aid in identifying key indicators for feasibility and optimal implementation of mHealth to prevent and/or decrease rates of secondary stroke. Our objective was to ascertain stroke patients' attitudes toward using mobile phone enabled blood pressure (BP) monitoring and medication adherence and identify factors that modulate these attitudes. METHODS: Sixty stroke patients received a brief demonstration of mHealth devices to assist with BP control and medication adherence and a survey to evaluate willingness to use this technology. RESULTS: The 60 participants had a mean age of 57 years, were 43.3% male, and 53.3% were White. With respect to telecommunication prevalence, 93.3% owned a cellular device and 25% owned a smartphone. About 70% owned a working computer. Regarding attitudes, 85% felt comfortable with a doctor or nurse using mHealth technologies to monitor personal health information, 78.3% believed mHealth would help remind them to follow doctor's directions, and 83.3% were confident that technology could effectively be used to communicate with health care providers for medical needs. CONCLUSIONS: Mobile device use is high in stroke patients and they are amenable to mHealth for communication and assistance in adhering to their medical regimens. More research is needed to explore usefulness of this technology in larger stroke populations.

Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial.

BACKGROUND: Hypertension is the premier modifiable risk factor for recurrent stroke. In sub-Saharan Africa (SSA) where the stroke burden is escalating, little is known about the role of behavioral interventions in enhancing blood pressure (BP) control after stroke. Our objective is to test whether an m-Health technology-enabled, nurse-led, multilevel integrated approach is effective in improving BP control among Ghanaian stroke patients within 1 month of symptom onset compared with standard of care. METHODS: This two-arm cluster randomized controlled feasibility pilot trial will involve 60 recent-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated into four clusters of 15 patients each per physician: two clusters in the intervention arm and two in the control arm. Patients in the intervention arm will receive a simple pillbox, a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake under nurse guidance for 3 months. Tailored motivational text messages will be delivered based upon levels of adherence to the medication intake. Both groups will be followed up for 6 months to compare BP control at months 3, 6 and 9 as primary outcome measure. Physicians assessing BP control will be blinded to arms into which patients are allocated. Secondary outcome measures will include medication adherence scores and Competence and Autonomous Self-regulation Scale scores. A qualitative study is planned after follow-up to explore the lived experiences of participants in the intervention arm. DISCUSSION: A feasible and preliminarily effective intervention would lead to a larger more definitive efficacy/effectiveness randomized controlled trial powered to look at clinical events, with the potential to reduce stroke-related morbidity and mortality in a low- to middle-income country. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02568137 , registered on 13 July 2015.