A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial.

BACKGROUND: A cardiovascular polypill containing generic drugs might facilitate sustained implementation of and adherence to evidence-based treatments, especially in resource-limited settings. However, the impact of a cardiovascular polypill in mitigating atherosclerotic risk among stroke survivors has not been assessed. We aimed to compare a polypill regimen with usual care on carotid intima-media thickness (CIMT) regression after ischaemic stroke. METHODS: In SMAART, a phase 2 parallel, open-label, assessor-masked, randomised clinical trial, we randomly allocated individuals (aged ≥18 years) who had an ischaemic stroke within the previous 2 months, using a computer-generated randomisation sequence (1:1), to either a polypill or usual care group at a tertiary centre in Ghana. The polypill regimen was a fixed-dose pill containing 5 mg ramipril, 50 mg atenolol, 12·5 mg hydrochlorothiazide, 20 mg simvastatin, and 100 mg aspirin administered as two capsules once per day for 12 months. Usual care was tailored guideline-recommended secondary prevention medications. The primary outcome was the change in CIMT over 12 months with adjustment for baseline values, compared using ANCOVA in all participants with complete data at month 12. Safety was analysed in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, NCT03329599, and is completed. FINDINGS: Between Feb 12, 2019, and Dec 4, 2020, we randomly assigned 148 participants (74 to the usual care group and 74 to the polypill group), 74 (50%) of whom were male and 74 (50%) female. CIMT was assessed in 62 (84%) of 74 participants in the usual care group and 59 (80%) of 74 participants in the polypill group; the main reason for loss to follow-up was participants not completing the study. The mean CIMT change at month 12 was -0·092 mm (95% CI -0·130 to -0·051) in the usual care group versus -0·017 mm (-0·067 to 0·034) in the polypill group, with an adjusted mean difference of 0·049 (-0·008 to 0·109; p=0·11). Serious adverse events occurred among two (3%) participants in the usual care group, and eight (11%) participants in the polypill group (p=0·049). INTERPRETATION: The polypill regimen resulted in similar regression in subclinical atherosclerosis and many secondary and tertiary outcome measures as the tailored drug regimen, but with more serious adverse events. Larger, longer-term, event-based studies, including patients with stroke in primary care settings, are warranted. FUNDING: US National Institutes of Health. TRANSLATION: For the Akan (Twi) translation of the abstract see Supplementary Materials section.

Patient-level and system-level determinants of stroke fatality across 16 large hospitals in Ghana and Nigeria: a prospective cohort study.

BACKGROUND: Every minute, six indigenous Africans develop new strokes. Patient-level and system-level contributors to early stroke fatality in this region are yet to be delineated. We aimed to identify and quantify the contributions of patient-level and system-level determinants of inpatient stroke fatality across 16 hospitals in Ghana and Nigeria. METHODS: The Stroke Investigative Research and Educational Network (SIREN) is a multicentre study involving 16 sites in Ghana and Nigeria. Cases include adults (aged ≥18 years) with clinical and radiological evidence of an acute stroke. Data on stroke services and resources available at each study site were collected and analysed as system-level factors. A host of demographic and clinical variables of cases were analysed as patient-level factors. A mixed effect log-binomial model including both patient-level and system-level covariates was fitted. Results are presented as adjusted risk ratios (aRRs) with respective 95% CIs. FINDINGS: Overall, 814 (21·8%) of the 3739 patients admitted with stroke died as inpatients: 476 (18·1%) of 2635 with ischaemic stroke and 338 (30·6%) of 1104 with intracerebral haemorrhage. The variability in the odds of stroke fatality that could be attributed to the system-level factors across study sites assessed using model intracluster correlation coefficient was substantial at 7·3% (above a 5% threshold). Stroke units were available at only five of 16 centres. The aRRs of six patient-level factors associated with stroke fatality were: low vegetable consumption, 1·19 (95% CI 1·07-1·33); systolic blood pressure, 1·02 (1·01-1·04) for each 10 mm Hg rise; stroke lesion volume more than 30 cm3, 1·48 (1·22-1·79); National Institutes of Health Stroke Scale (NIHSS) score, 1·20 (1·13-1·26) for each 5-unit rise; elevated intracranial pressure, 1·75 (1·31-2·33); and aspiration pneumonia, 1·79 (1·16-2·77). INTERPRETATION: Studies are needed to assess the efficacy of interventions targeting patient-level factors such as aspiration pneumonia in reducing acute stroke fatality in this region. Policy directives to improve stroke unit access are warranted. FUNDING: US National Institutes of Health. TRANSLATIONS: For the Twi, Yoruba and Hausa translations of the abstract see Supplementary Materials section.

Clinical and laboratory profile and outcomes of hospitalized COVID-19 patients with type 2 diabetes mellitus in Ghana - A single-center study.

BACKGROUND: In sub-Saharan Africa and particularly in Ghana, there is scarcity of published literature specifically on the impact of DM on outcomes in COVID-19 patients. Based on the difference in genetic makeup and demographic patterns in Africans compared to the Western world and with the rising burden of DM and other non-communicable diseases in Ghana there is a need to define the impact DM has on persons with COVID-19. This would ensure adequate risk stratification and surveillance for such patients as well as appropriate scale up of therapeutic management if needed. AIMS: This single-center study describes the clinical and laboratory profile and outcomes of COVID-19 in-patients with type 2 diabetes mellitus (DM) in Ghana. MATERIALS AND METHODS: Retrospective analysis was undertaken of the medical records of adults with COVID-19 hospitalized at a facility in Ghana from March to October 2020. Clinical, laboratory and radiological data and outcomes were analysed. Comparisons between COVID-19 patients with DM and non-diabetics were done with an independent t-test or a Mann-Whitney test when normality was not attained. Odds ratios (95% CI) were calculated using univariate logistic regression. RESULTS: Out of 175 COVID-19 patients, 64 (36.6%) had DM. Overall mean age was 55.9 ± 18.3 years; DM patients were older compared to non-diabetics (61.1 ± 12.8 vs. 53.0 ± 20.2 years, p = .049). Compared to non-diabetics, diabetics were more likely to have higher blood glucose at presentation, have hypertension, be on angiotensin 2 receptor blockers [OR, 95% CI 3.3 (1.6-6.7)] and angiotensin converting enzyme inhibitors [OR, 95% CI 3.1 (1.3-7.4)]; and be HIV negative (p < .05). Although the values were normal, diabetics had a higher platelet count but decreased lymphocytes, aspartate transaminase and alkaline phosphatase compared to non-diabetics (p < .05). There was no difference in clinical symptoms, severity or mortality between the two groups. DISCUSSION: The clinical profile of patients studied are similar to prior studies. However the outcome of this study showed that DM was not associated with worse clinical severity and in-hospital mortality. This could have been due to majority of DM patients in this study having relatively good blood glucose control on admission. Secondly, DM alone may not be a risk factor for mortality. Rather its concurrent existence with multiple co-morbidities (especially cardiovascular co-morbidities which may predispose to pro-inflammatory and pro-thrombotic states) may be driving the rise in severity and mortality risks reported in other studies. Furthermore, this study was conducted among an African population and Africa has been shown to be generally less severely hit by the COVID-19 pandemic compared to other regions outside the continent. This has been postulated to be due, among other factors, to inherent protective mechanisms in Africans due to early and repeated exposure to parasitic and other organisms resulting in a robust innate immunity. CONCLUSIONS: This study suggested that DM was not associated with more severe clinical symptoms or worse outcomes among hospitalized COVID-19 patients. Despite this, it is important that DM patients adhere to their therapy, observe the COVID-19 containment protocols and are prioritized in the administration of the COVID-19 vaccines. STUDY HIGHLIGHTS: In this retrospective, single-centre study on the clinical and laboratory profile and outcome of hospitalized DM patients with COVID-19, patients with DM did not have a more severe clinical profile or worse outcomes. They were, however, significantly older, more likely to have higher admission blood glucose, have hypertension, be on angiotensin 2 receptor blockers and angiotensin converting enzyme inhibitors; and be HIV negative compared to the cohort without DM. DM patients should be a priority group for the COVID-19 vaccines.

Phone-Based Intervention under Nurse Guidance after Stroke (PINGS II) Study: Protocol for a Phase III Randomized Clinical Trial.

OBJECTIVES: The Sub-Saharan African (SSA) region now has the highest estimated effect size of hypertension for stroke causation worldwide. An urgent priority for countries in SSA is to develop and test self-management interventions to control hypertension among those at highest risk of adverse outcomes. Thus the overall objective of the Phone-based Intervention under Nurse Guidance after Stroke II study (PINGS-2) is to deploy a hybrid study design to assess the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to improve longer term blood pressure (BP) control among stroke survivors. MATERIALS AND METHODS: A phase III randomized controlled trial involving 500 recent stroke survivors to be enrolled across 10 Ghanaian hospitals. Using a computer-generated sequence, patients will be randomly assigned 1:1 into the intervention or usual care arms. The intervention comprises of (i) home BP monitoring at least once weekly with nurse navigation for high domiciliary BP readings; (2) medication reminders using mobile phone alerts and (3) education on hypertension and stroke delivered once weekly via audio messages in preferred local dialects. The intervention will last for 12 months. The control group will receive usual care as determined by local guidelines. The primary outcome is the proportion of patients with systolic BP <140 mm Hg at 12 months. Secondary outcomes will include medication adherence, self-management of hypertension, major adverse cardiovascular events, health related quality of life and implementation outcomes. CONCLUSION: An effective PINGS intervention can potentially be scaled up and disseminated across healthcare systems in low-and-middle income countries challenged with resource constraints to reduce poor outcomes among stroke survivors.

Atherosclerotic event risk and risk reduction therapies among Ghanaian hemorrhagic stroke survivors.

BACKGROUND: Intracerebral hemorrhage (ICH) stroke constitute up to 40% of incident strokes in Africa. While ICH patients are at high risk for atherosclerotic events, the risk-benefit of anti-atherosclerotic therapies in this patient population is uncertain. PURPOSE: To assess whether utility of statins and/or antithrombotic agents after surviving an ICH correlates with atherosclerotic risk of an observational cohort. METHODS: We analyzed data in a stroke registry prospectively collected on consecutively encountered stroke survivors seen at an out-patient clinic in Ghana between January 2018 and March 2020. We collected baseline demographic and clinical details, including diagnosis of ICH, co-morbidities, and key atherosclerotic risk reduction therapies (statins and anti-platelet drugs). We computed ischemic vascular risk using the Framingham Risk Score (FRS) to classify patients into low, intermediate and high vascular risk. RESULTS: Of 1101 stroke survivors seen during the period, 244 (22.2%) had ICH. Vascular risk profiles were low (n = 86; 35.2%), intermediate (n = 71; 29.1%) and high (n = 87; 35.7%). Utility of statin use was 76.7% (low risk), 84.5% (intermediate risk), and 87.4% (high risk), p = 0.16 while antiplatelet use trended with atherosclerotic risk being 9.3% (low risk), 25.4% (intermediate risk), and high risk (34.5%), p = 0.0004. Independent factors associated with statin use were hypertension (OR 8.80; 95% CI: 2.34-33.11) and cigarette smoking (OR 0.29; 95% CI: 0.09-0.89) while antiplatelet drug use was associated with age (OR 1.43; 95% CI: 1.06-1.92) and time from index stroke (OR: 1.02; 95% CI: 1.01-1.02). CONCLUSION: Approximately two-thirds of ICH survivors in this African sample had intermediate to high risk of future atherosclerotic events. Clinical trials on the timing, safety, and efficacy of statins and antiplatelet drugs among ICH survivors could help better guide risk mitigation in this population.

Prevalence and predictors of post-stroke epilepsy among Ghanaian stroke survivors.

BACKGROUND: Post-stroke epilepsy (PSE) is associated with poorer quality of life, higher mortality, and greater health expenditures. We are unaware of any published reports on the frequency of and factors associated with PSE in Africa. PURPOSE: To assess the frequency and factors associated with PSE among Ghanaian stroke survivors. METHODS: We conducted a cross-sectional study of consecutive stroke survivors seen at an out-patient Neurology clinic enrolled into a stroke registry at a tertiary medical center in Ghana between January 2018 and March 2020. We collected baseline demographic and clinical details including diagnosis of post-stroke epilepsy, anti-epileptic medications, presence, treatment and control of vascular risk factors. Multivariate logistic regression models were constructed to identify factors associated with PSE. RESULTS: Of 1101 stroke patients encountered, 126 had PSE (frequency of 11.4%; 95% CI of 9.6-13.5%). Mean (± SD) age among PSE vs. non-PSE patients was 57.7 (± 15.2) vs. 58.7 (± 13.9) years. Factors independently associated with PSE were being male (aOR 1.94; 95% CI: 1.32-2.86), cortical ischemic strokes (1.79; 1.12-2.87), blood pressure > 130/80 mmHg (OR 2.26; 1.06-4.79), use of antihypertensive treatment (OR 0.43; 0.23-0.79). There was an inverted J-shaped curve association between number of classes of antihypertensive drugs prescribed and occurrence of PSE, with the lowest inflection point at 3 classes (OR 0.34; 0.17-0.68). CONCLUSION: In this convenience sample of ambulatory Ghanaian stroke survivors, one in ten had PSE. Further investigations to confirm and clarify the associations between the identified demographic and clinical characteristics are warranted.

Frequency and factors linked to refractory hypertension among stroke survivors in Ghana.

BACKGROUND: Refractory hypertension (RfH) is a rare, severe phenotype of resistant hypertension, linked to higher risk of adverse cardiovascular outcomes. Little is known about the association of RfH with stroke type and subtype. OBJECTIVE: To determine the prevalence and predictors of RfH among stroke survivors in Ghana. METHODS: We interrogated the dataset of a prospectively collected registry of hypertensive patients seen between July 2015 and June 2019, at five hospitals in Ghana. We compared stroke survivors to stroke-free controls. Clinic-based blood pressure was measured using a standardized protocol and antihypertensive medications were assessed via review of medical records and inspection of pills. Refractory hypertension was defined as office BP ≥140/90 mmHg on ≥5 classes of antihypertensive medications. Multivariate logistic regression models were constructed to assess factors associated with RfH. RESULTS: Of 3927 hypertensive patients (1169 stroke survivors, 2758 controls), 86 had RfH for an overall prevalence of 2.2% (95% CI: 1.8-2.7%). Among patients with RfH, 5.8% (4.5-7.3%) were stroke survivors vs. 0.7% (0.4-1.0%) were stroke-free (p < .0001). Adjusted odds ratio (95% CI) for factors associated with RfH were being male (1.81, 1.15-2.85), age < 60 years (2.64, 1.59-4.40), chronic kidney disease (2.09, 1.21-3.60), and known stroke (7.53, 4.35-13.04). RfH was associated with intracerebral hemorrhage, (11.43, 5.65-23.14), ischemic stroke (9.76, 5.47-17.42), lacunar stroke (13.58, 6.45-28.61), and non-lacunar ischemic stroke (3.67, 1.04-13.02). CONCLUSION: Presence of RfH is significantly accentuated among stroke survivors. Intensified efforts are warranted to identify and aggressively address barriers to control in these patients to avert subsequent vascular events.

The dynamics of Poststroke depression among Ghanaians.

OBJECTIVE: The very few published data on post-stroke depression (PSD) among indigenous Africans have covered its prevalence and predictors. We sought to evaluate the dynamics of PSD in a cohort of Ghanaian stroke survivors followed for 9 months after an acute stroke. METHODS: Stroke survivors in this prospective cohort were adults aged >18 years with CT scan confirmed stroke, recruited into a randomized controlled trial to assess the feasibility of an mHealth technology-enabled, nurse guided intervention for blood pressure control. PSD was assessed a secondary outcome measure using the Hamilton Depression Rating Scale (HDRS) at enrollment, months 3, 6, and 9. Those with a score of >7 points on HDRS were categorized as depressed. A multivariate logistic regression analysis was performed to identify independent predictors of PSF. RESULTS: Mean age of study participants was 55.1 ±â€¯12.7 years with 65% being males. Ischemic strokes comprised 76.6% of study population. Prevalence of PSD at baseline was 78.6%, 43.6% at month 3, 41.1% at month 6 and 18.2% at month 9 (p < .0001). Factors significantly associated with PSD at baseline were higher NIH Stoke Scale score (adjusted OR 1.51, 95% CI: 1.03-2.23) and pain (adjusted OR 7.18, 95% CI: 1.52-33.89). NIHSS score (adjusted OR, 1.99, 95% CI: 1.12-3.52) as associated with PSD at month 9. CONCLUSION: 80% Ghanaian stroke survivors have early PSD declining to 20% at month 9. Stroke severity is the persistent factor associated with PSD at baseline and follow-up, and good be a target for screening and promptly treating PSD.

Estimated glomerular filtration rate predicts incident stroke among Ghanaians with diabetes and hypertension.

BACKGROUND: Sub-Saharan Africa is currently experiencing a high burden of both chronic kidney disease (CKD) and stroke as a result of a rapid rise in shared common vascular risk factors such as hypertension and diabetes mellitus. However, no previous study has prospectively explored independent associations between CKD and incident stroke occurrence among indigenous Africans. This study sought to fill this knowledge gap. METHODS: A prospective cohort study involving Ghanaians adults with hypertension or type II diabetes mellitus from 5 public hospitals. Patients were followed every 2 months in clinic for 18 months and assessed clinically for first ever stroke by physicians. Serum creatinine derived estimated glomerular filtration rates (eGFR) were determined at baseline for 2631 (81.7%) out of 3296 participants. We assessed associations between eGFR and incident stroke using a multivariate Cox Proportional Hazards regression model. RESULTS: Stroke incidence rates (95% CI) increased with decreasing eGFR categories of 89, 60-88, 30-59 and <29 ml/min corresponding to incidence rates of 7.58 (3.58-13.51), 14.45 (9.07-21.92), 29.43 (15.95-50.04) and 66.23 (16.85-180.20)/1000 person-years respectively. Adjusted hazard ratios (95%CI) for stroke occurrence according to eGFR were 1.42 (0.63-3.21) for eGFR of 60-89 ml/min, 1.88 (1.17-3.02) for 30-59 ml/min and 1.52 (0.93-2.43) for <30 ml/min compared with eGFR of >89 ml/min. Adjusted HR for stroke occurrence among patients with hypertension with eGFR<60 ml/min was 3.69 (1.49-9.13), p = .0047 and among those with diabetes was 1.50 (0.56-3.98), p = .42. CONCLUSION: CKD is dose-dependently associated with occurrence of incident strokes among Ghanaians with hypertension and diabetes mellitus. Further studies are warranted to explore interventions that could attenuate the risk of stroke attributable to renal disease among patients with hypertension in SSA.

Phone-based intervention for blood pressure control among Ghanaian stroke survivors: A pilot randomized controlled trial.

BACKGROUND: The potential of mobile-health (mHealth) technology for the management of hypertension among stroke survivors in Africa remains unexplored. We assessed whether an mHealth technology-enabled, nurse-guided intervention initiated among stroke patients within one month of symptom onset is effective in improving their blood pressure (BP) control. METHODS: A two-arm pilot cluster randomized controlled trial involving 60 stroke survivors, ≥18 years, with BP ≥140/90 mmHg at screening/enrollment visit at a medical center in Ghana. Participants in the intervention arm (n = 30) received a Blue-toothed BP device and smartphone with an App for monitoring BP measurements and medication intake under nurse guidance for three months after which intervention was withdrawn. Control arm (n = 30) received usual care. Primary outcome measure was proportion with clinic BP < 140/90 mmHg at month 9; secondary outcomes included medication adherence. FINDINGS: Mean ± SD age was 55 ± 13 years, 65% males. Two participants on intervention and three in control group were lost to follow-up. At month 9, proportion on the intervention versus controls with BP < 140/90 mmHg was 14/30 (46.7%) versus 12/30 (40.0%), p = 0.79 by intention-to-treat; systolic BP < 140 mmHg was 22/30 (73.3%) versus 13/30 (43.3%), p = 0.035. Mean ± SD medication possession ratio was 0.95 ± 0.16 on intervention versus 0.98 ± 0.24 in the control arm, p = 0.56. INTERPRETATION: We demonstrate feasibility and signal of improvement in BP control among stroke survivors in a resource-limited setting via an mHealth intervention. Larger scale studies are warranted. TRIAL REGISTRATION: NCT02568137. Registered on 13 July 2015 at ClinicalTrials.gov.

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial.

BACKGROUND: There is an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA). Secondary prevention guidelines recommend that antihypertensive, statin and antiplatelet therapy be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular-risk reduction. However, these goals are seldom realized in routine clinical care settings in SSA due to logistical challenges. We seek to assess whether a polypill containing fixed doses of three antihypertensive agents, a statin and antiplatelet therapy taken once daily per os for 12 months among recent stroke survivors would result in carotid intimal thickness regression compared with usual care (UC). METHODS: The Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is a phase 2, open-label, evaluator-blinded trial involving 120 Ghanaian recent-ischemic-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated 1:1 into either the intervention arm or UC. Patients in the intervention arm will receive Polycap DS® (containing aspirin, 100 mg; atenolol, 50 mg; ramipril, 5 mg; thiazide, 12.5 mg; simvastatin, 20 mg) taken as two capsules once daily. Patients in the UC will receive separate, individual secondary preventive medications prescribed at the physician's discretion. Both groups will be followed for 12 months to assess changes in carotid intimal thickness regression - a surrogate marker of atherosclerosis - as primary outcome measure. Secondary outcome measures include adherence to therapy, safety and tolerability, health-related quality of life, patient satisfaction, functional status, depression and cognitive dysfunction. DISCUSSION: An efficacy-suggesting SMAART trial could inform the future design of a multi-center, double-blinded, placebo-controlled, parallel-group, randomized controlled trial comparing the clinical efficacy of the polypill strategy for vascular risk moderation among stroke survivors in SSA. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT03329599 . Registered on 11 February 2017.

Long-Term Outcomes of Stroke in a Ghanaian Outpatient Clinic.

BACKGROUND: Compared with high-income countries, sub-Saharan African (SSA) countries experience a comparatively higher early mortality from stroke. However, data on long-term mortality from stroke in SSA are lacking. OBJECTIVE: Our aim is to assess long-term outcomes of stroke in an SSA setting. METHODS: We conducted a retrospective analysis of longitudinal data involving 607 consecutive stroke survivor encountered at an outpatient clinic in Kumasi, Ghana, between January 2012 and June 2014. Data were closed for analysis in June 2016. Data on demography, presence of vascular risk factors, stroke type, and functional status were evaluated. We followed up subjects who were no longer attending clinic by phone to assess their vital status. Primary outcome was death after initiation of clinic care, and its predictors were determined using a Cox proportional hazards regression model. RESULTS: Mean ± standard deviation (SD) age of cohort was 59.9 ± 13.9 years and 50.3% were female. Of the 607 stroke survivors, 377 (62.1%) were still alive, 59 (9.7%) were confirmed to have died, whereas 171 (28.2%) were lost to follow-up at the clinic. Mean ± SD observation time for the cohort was 32 ± 30 months. Upon adjustment for confounders, the independent predictors of mortality were age (adjusted hazard ratio [aHR] of 1.41 [95% confidence interval 1.15-1.73] for a 10-year increase in age) and diabetes mellitus (aHR of 2.24 [1.32-3.80]). CONCLUSIONS: Diabetes mellitus, a modifiable risk factor for stroke, is associated with an increased risk of mortality among West African stroke survivors over the long term.

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Stroke exacts an immense toll in sub-Saharan Africa where there are few resources, and stroke prevention research is limited. The aim of this study is to test the feasibility and preliminary efficacy of an m-Health technology-enabled, nurse-guided intervention in improving blood pressure (BP) control among Ghanaian stroke patients within 1 month of symptom onset. METHODS: We conducted a 2-arm cluster pilot randomized controlled trial involving 60 recent stroke survivors encountered within a single tertiary medical system in Ghana. Subjects in the intervention arm (n=30) received a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake for 3 months compared with standard of care (n=30). Primary outcome measure was systolic BP <140 mm Hg at month 3; secondary outcomes included medication adherence and autonomous self-regulation. Analysis accounting for clustering was made using generalized linear mixed model by intention to treat. RESULTS: Mean±SD age was 55±13 years, 65% male. Systolic BP <140 mm Hg at month 3 was found in 20/30 subjects (66.7%) in the intervention arm versus 14/30 subjects (46.7%) in the control arm (P=0.12). Medication possession ratio scores at month 3 were better in the intervention (0.88±0.40) versus control (0.64±0.45) arm (P=0.03). One subject in control arm died from a recurrent hemorrhagic stroke. CONCLUSIONS: It is feasible to conduct an m-Health-based, nurse-guided BP control intervention among recent stroke patients in sub-Saharan Africa. We observed a potential signal of efficacy with the intervention, which will need to be tested in a future large definitive study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02568137.

Plasma Glial Fibrillary Acidic Protein, Copeptin, and Matrix Metalloproteinase-9 Concentrations among West African Stroke Subjects Compared with Stroke-Free Controls.

BACKGROUND: Measurement of plasma molecular markers among stroke patients has been proposed as an avenue for improving the accuracy of stroke diagnosis. There is paucity of data on the potential role of these markers in resource-limited settings, where the burden of stroke is greatest. OBJECTIVE: To assess the potential diagnostic and prognostic performance of 3 proposed biomarkers for stroke in a resource-constrained setting. METHODS: Consecutive stroke subjects presenting at a tertiary medical center in Kumasi, Ghana, with radiologically confirmed diagnosis and etiologic subtype information available were recruited along with age- and gender-matched controls in a 2:1 ratio. Plasma concentrations of glial fibrillary acidic protein (GFAP), copeptin, and matrix metalloproteinase-9 (MMP-9) among stroke patients and stroke-free controls were measured in duplicates using enzyme linked immunoassays. Diagnostic and prognostic correlates were assessed using area-under-the-curve (AUC) measures of receiver operator curves and logistic regression analysis, respectively. RESULTS: There were 156 stroke subjects with a mean age of 61.3 years of which 47.4% were females and 74 age- and gender-matched stroke-free controls. Median (interquartile range) time from symptom onset to hospital presentation for care was 7 days (5-11). Diagnostic accuracy of a single measurement of the 3 biomarkers for stroke using AUC (95% confidence interval) plots were as follows: .84 (.77-0.91), P < .0001, for GFAP; .85 (.79-0.92), P < .0001, for copeptin; and .65 (.56-0.73), P = .0003, for MMP-9. None of the biomarkers was associated with stroke severity or mortality. CONCLUSION: Plasma concentrations of GFAP and copeptin demonstrated stronger associations with stroke occurrence in this West African cohort compared with controls.

Potential role of tele-rehabilitation to address barriers to implementation of physical therapy among West African stroke survivors: A cross-sectional survey.

BACKGROUND: The greatest burden from stroke-related disability is borne by Low-and-Middle Income countries (LMICs) where access to rehabilitation after stroke is severely challenged. Tele-rehabilitation could be a viable avenue to address unmet rehabilitation needs in LMICs. OBJECTIVES: To assess the burden of post-stroke physical deficits, rates of utilization of physiotherapy services, and perceptions of tele-rehabilitation among recent Ghanaian stroke survivors. METHODS: Using a consecutive sampling strategy, 100 stroke survivors attending an outpatient Neurology clinic in a Ghanaian tertiary medical center were enrolled into this cross-sectional study. After collecting basic demographic data, clinical history on stroke type, severity and level of disability, we administered the validated 20-item Functional Independence Measure questionnaire to evaluate functional status of study participants and an 8-item questionnaire to assess participants' attitudes towards telemedicine administered rehabilitation intervention. RESULTS: Mean±SD age of study participants was 57.2±13.3years of which 51.0% were males with a mean duration of stroke of 1.3±2.2years. 53% had Modified Rankin scores of ≥3, 57% were fully independent and only 27% reported utilizing any physiotherapy services. Barriers to access to physiotherapy included financial constraints due to cost of physiotherapy services and transportation as well as premature discharge from physiotherapy to avoid overburdening of available physiotherapy services. These factors led to the limited provision of rehabilitative therapy. Participants held positive views of the potential for tele-rehabilitation interventions (80-93%). However, while 85% owned mobile phones, only 35% had smart phones. CONCLUSION: Despite, a high burden of residual disability, only about 1 out of 4 stroke patients in this Ghanaian cohort was exposed to post-stroke physiotherapy services, largely due to relatively high costs and limited health system resources. These Ghanaian stroke patients viewed the potential role of Tele-rehabilitation as positive, but this promising intervention needs to be formally tested for feasibility, efficacy and cost-effectiveness.

Tele-neurology in sub-Saharan Africa: A systematic review of the literature.

BACKGROUND: The rapid advancement in telecommunications on the African continent has opened up avenues for improving medical care to underserved populations. Although the greatest burden of neurological disorders is borne by Low-and-Middle Income Countries (LMICs) including sub-Saharan Africa (SSA), there is a profound paucity of neurologists to serve the population. Telemedicine presents a promising avenue for effective mobilization and utilization of the few neurologists in Africa. OBJECTIVE: To systematically review the published literature on the use of telemedicine for improved care and outcomes for patients with neurological disorders in SSA. METHODS: We searched PubMed and Cochrane library from January 1, 1980 to April 30, 2017 using the following keywords: "Telemedicine neurology Africa", "Teleneurology Africa", "Telestroke Africa", "Telerehabilitation Africa", "Telemedicine for epilepsy", "Telemedicine for Parkinson's disease Africa", "Telemedicine for dementia Africa", "Telehealth neurology Africa". Our inclusion criteria were randomized controlled trials, or case series that reported the utilization of telemedicine for care/education of individuals with neurological disorders in sub-Saharan Africa. RESULTS: This search yielded 6 abstracts. By consensus between two investigators, 1 publication met the criteria for inclusion and further review. The one study identified utilized telemedicine for the purpose of improving education/knowledge of 16 doctors and 17 allied health professionals in Parkinson's disease (PD) in Cameroon. The study noted feasibility and satisfaction of participants with telemedicine as well as improved knowledge base of participants after the educational course but noted access to healthcare by patients did not change. No studies have evaluated the use of telemedicine for care of patients with neurological disorders. CONCLUSION: The indication is that teleneurology may be feasible in SSA and studies are needed to assess feasibility, acceptability, efficacy, cost-effectiveness of this promising discipline of neurology in these resource-limited settings. We propose the setting up of trans­continental, inter-regional, intra-regional, and national networks of neurologists to utilize teleneurology platforms to improve the reach of neurology care in SSA.

Burden and Predictors of Poststroke Cognitive Impairment in a Sample of Ghanaian Stroke Survivors.

BACKGROUND AND OBJECTIVE: There are limited data on vascular cognitive impairment (VCI) from low- and middle-income countries where the stroke burden is burgeoning. The aim of this study was to characterize the burden, determinants, and effects of VCI on health-related quality of life in sub-Saharan Africa (SSA). METHODS: From January 2015 to February 2016, we collected information on 147 consecutive stroke survivors (>45 years) seen at a tertiary hospital in Ghana and 49 demographically matched stroke-free controls. Data collected included demographics, clinical factors, health-related quality of life, and presence of depression. Cognitive status was evaluated using a standard Vascular Neuropsychological Battery that assessed memory, executive function and mental speed, language, and visuospatial-visuoconstructive functioning. Expert VCI guideline and Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria were used to classify stroke patients into no VCI, VCI but no dementia, and vascular dementia (VD). RESULTS: The mean age ± standard deviation of the stroke survivors was 59.9 ± 13.7 years, of which 47.6% were women. Among the cohort, 77 out of 147 (52.3%) had no VCI, 50 of the 147 (34.0%) had VCI without dementia, and 20 of the 147 (13.6%) had VD. Three factors remained significantly associated with VCI: increasing age for each successive 10-year rise (odds ratio [OR] 1.44, 95% confidence interval [CI]: 1.03-2.02), lack of formal education (OR 5.26, 95% CI: 1.01-27.52), and worse functional disability on the modified Rankin scale (OR 2.46, 95% CI: 1.61-3.75). Patients with VD had the poorest health-related quality of life. CONCLUSIONS: Half of the Ghanaian stroke survivors encountered in this cross-sectional study had evidence of cognitive dysfunction. Future studies in SSA will need to identify strategies to address this immense burden.

Administration of a pictorial questionnaire to screen for stroke among patients with hypertension or diabetes in rural Ghana.

BACKGROUND: Stroke prevention is an important public health goal in low-and-middle income countries (LMIC) due to its high mortality and morbidity in these settings. Epidemiological data from high-income countries have demonstrated a potent predictive association between self-reported stroke symptoms and risks of future strokes, incident cognitive impairment and all-cause mortality. OBJECTIVE: To utilize a pictographic version of the 8-item Questionnaire for Verifying Stroke Free Status (QVSFS) to screen for stroke symptoms and determine its predictors among hypertensive and diabetic patients in a rural hospital within a LMIC. METHODS: Between July and October 2016, 500 consecutive patients with hypertension and/or diabetes mellitus encountered in clinic at the Agogo Presbyterian Hospital, a district level health institution in Ghana were enrolled. A validated pictographic version of the QVSFS was administered by trained research assistants to all study participants and demographic and clinical information on hypertension and diabetes control were collected. The neurologist/specialist physician examined all patients neurologically using a structured questionnaire and reviewed medical charts for objective documentary evidence of stroke. Predictors of stroke symptoms were assessed using a multivariate logistic regression model. RESULTS: Among the cohort, median (IQR) age was 58 (51-66) years, 399 (79.8%) were women, 388 (77.6%) had hypertension, 92 (18.4%) had diabetes and hypertension, and 20 (4.0%) had just diabetes. 30 (6.0%) patients had confirmed stroke/TIA after physician evaluation, 151 (30.6%) had at least one symptom of stroke (SS) without prior diagnosis of stroke/TIA and 319 (63.8%) reported no stroke symptoms. Independent predictors of reporting stroke symptoms were increasing age - aOR: 1.38 (1.16-1.64) for each 10years older and HBA1C-OR: 1.74 (1.16-2.61) for each 2% increase. Subjects with previous stroke/TIA diagnosis had significantly higher mean±SD systolic blood pressure (148.0±21.2mmHg vs. 136.0±17.3mmHg vs. 138.3±19.7mmHg, p=0.009) and median (IQR) HBA1C (8.8% (6.7-10.2) vs. 8.2 (6.4-10.6) vs. 7.2 (6.3-8.0), p=0.05) compared with SS and asymptomatic groups. CONCLUSION: One in three patients with hypertension and/diabetes in rural Ghana report stroke-like symptoms. Routine use of the pictographic version of the QVSFS could assist in identifying patients with or at high risk for stroke who may benefit from appropriate prevention treatments.

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.

Phenotyping Stroke in Sub-Saharan Africa: Stroke Investigative Research and Education Network (SIREN) Phenomics Protocol.

BACKGROUND: As the second leading cause of death and the leading cause of adult-onset disability, stroke is a major public health concern particularly pertinent in Sub-Saharan Africa (SSA), where nearly 80% of all global stroke mortalities occur, and stroke burden is projected to increase in the coming decades. However, traditional and emerging risk factors for stroke in SSA have not been well characterized, thus limiting efforts at curbing its devastating toll. The Stroke Investigative Research and Education Network (SIREN) project is aimed at comprehensively evaluating the key environmental and genomic risk factors for stroke (and its subtypes) in SSA while simultaneously building capacities in phenomics, biobanking, genomics, biostatistics, and bioinformatics for brain research. METHODS: SIREN is a transnational, multicentre, hospital and community-based study involving 3,000 cases and 3,000 controls recruited from 8 sites in Ghana and Nigeria. Cases will be hospital-based patients with first stroke within 10 days of onset in whom neurovascular imaging will be performed. Etiological and topographical stroke subtypes will be documented for all cases. Controls will be hospital- and community-based participants, matched to cases on the basis of gender, ethnicity, and age (±5 years). Information will be collected on known and proposed emerging risk factors for stroke. STUDY SIGNIFICANCE: SIREN is the largest study of stroke in Africa to date. It is anticipated that it will shed light on the phenotypic characteristics and risk factors of stroke and ultimately provide evidence base for strategic interventions to curtail the burgeoning burden of stroke on the sub-continent.