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.

One-Year Rates and Determinants of Poststroke Systolic Blood Pressure Control among Ghanaians.

BACKGROUND AND OBJECTIVE: Elevated systolic blood pressure (SBP) is potently associated with risk of recurrent strokes. In resource-limited settings, there is a dearth of data on the rates and determinants of uncontrolled SBP among stroke survivors at high risk of recurrent events. The objective of this study is to assess the rates and determinants of uncontrolled SBP over the first year post stroke. METHODS: This is a retrospective observational study involving stroke survivors who enrolled into an outpatient neurology clinic in Kumasi, Ghana, between January 2012 and June 2014. Baseline demographic features, clinical characteristics, antihypertensive medications prescribed at each clinic visit, treatment modifications, and clinic blood pressure measurements were recorded. Predictors of uncontrolled SBP during follow-up were assessed using a multivariable logistic regression model. RESULTS: A total of 602 stroke survivors enrolled for follow-up within the study period of which 89.8% had hypertension. Up to 35% of subjects had an SBP above 140 mmHg during follow-up clinic visits. Among those with uncontrolled SBP, 17% had antihypertensive treatment modifications during follow-up. Predictors of uncontrolled SBP were SBP at enrollment into clinic, with an adjusted odds ratio (OR [95% confidence interval {CI}]) of 1.31 (1.17-1.47)/10 mmHg increase, and average number of antihypertensive medications prescribed, with an adjusted OR (95% CI) of 1.30 (1.06-1.60) for an increase in the number of antihypertensives prescribed. CONCLUSION: A third of stroke survivors had SBP not on target during follow-up possibly due to a combination of therapeutic inertia, apparent treatment resistance, and poor adherence to therapy. Longer-term prospective interventional studies on hypertension control among stroke survivors are warranted in sub-Saharan Africa.

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.

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.

Research participants' perception of ethical issues in stroke genomics and neurobiobanking research in Africa.

Background: There is a growing interest in stroke genomics and neurobiobanking research in Africa. These raise several ethical issues, such as consent, re-use, data sharing, storage, and incidental result of biological samples. Despite the availability of ethical guidelines developed for research in Africa, there is paucity of information on how the research participants' perspectives could guide the research community on ethical issues in stroke genomics and neurobiobanking research. To explore African research participants' perspectives on these issues, a study was conducted at existing Stroke Investigation Research and Education Network (SIREN) sites in Nigeria and Ghana. Method: Using an exploratory design, twenty-eight Focus Group Discussions (FGDs) sessions were conducted with stroke survivors (n=7), caregivers(n=7), stroke - free controls(n=7), and Community Advisory Board members(n=7). Data were collected using an interview guide. Interviews were conducted in English and indigenous languages of the community, audio recorded, and transcribed verbatim. Data were analyzed using NVivo (March, 2020) Software. Result: Results revealed that stroke genomics and neurobiobanking research in Africa require researchers' direct attention to ethical issues. Concerns were raised about understanding, disclosure and absence of coercion as components of true autonomous decision making in research participation. Participants argued that the risk and benefits attached to participation should be disclosed at the time of recruitment. Fears around data sharing were voiced as adherence to the principle of privacy and confidentiality were of paramount importance to participants. The preference was to receive the results of incidental findings with no stigma attached from society. Conclusion: Research participants' perspectives are a vital aspect of community engagement in stroke genomics and neurobiobanking research. Findings from this study suggest that research participants are interested in these fields of research in Africa if their concerns about ethical issues are appropriately addressed within the research framework.

Feasibility, acceptability, and appropriateness of a mobile health stroke intervention among Ghanaian health workers.

BACKGROUND: mHealth interventions can improve care delivery in settings with limited resources. The Phone-based Interventions under Nurse Guidance after Stroke (PINGS) is a nurse-led, mHealth-centered approach to blood pressure (BP) control among recent stroke survivors with hypertension in Ghana. It has 4 key components: (1) home blood pressure monitoring, (2) nurse-coordinated mhealth consults, (3) phone alerts as medication reminders, and (4) patient motivational messages delivered as interactive voice recordings. OBJECTIVE: To assess the feasibility, acceptability, and appropriateness for scale up of the PINGS intervention in Ghana, from the perspective of health workers. METHODS: Between July and August 2021, we deployed an online questionnaire describing the components of PINGS to a cross-section of health workers in Ghana. The questionnaire used an adaptation of psychometrically validated Likert scale measures to elicit agreement or disagreement with attributes of the intervention. The questionnaire was distributed online to approximately 4000 healthcare workers via email and social media platforms. A summary of descriptive statistics was obtained; summed composite scores were then calculated, dichotomized, and binary logistic regression performed using R programming software. RESULTS: Of 653 health workers who completed the survey, 57.2% were male; 73.2% clinicians; median age was 33 years (IQR 29, 37). Respondents' primary workplaces were public (64.4%), quasi-government (9.4%), and private, including mission-based (26.2%) facilities. PINGS was deemed feasible, acceptable, and appropriate by 93.9%, 94.8%, and 95.1% of respondents respectively. Clinical staff had higher odds of finding PINGS feasible (OR 4.10; C.I. 2.15, 8.0; p < 0.001), acceptable (OR 3.76, C.I. 1.87, 7.69; p < 0.001), or appropriate (OR 2.91, C.I. 1.41, 5.95; p = 0.004) compared to non-clinical staff. There was no statistically significant difference in the rating of each measure when analyzed by age, sex, years of health work experience, geographic location, type, or level of health facility. CONCLUSION: An overwhelming majority of health workers (particularly clinical staff) considered PINGS to be a feasible, acceptable, and appropriate for BP control among stroke survivors in Ghana.

COVID-19 and stroke: Experience in a Ghanaian healthcare system.

BACKGROUND: The novel coronavirus disease 19 (COVID-19) causes multi-system disease including possibly heightened stroke risk. Data from high-income countries (HIC) suggest disruptions to care delivery with reduced stroke admissions and administration of acute stroke reperfusion therapies. We are unaware of any published data on the impact of the COVID-19 pandemic on stroke admissions and outcomes in sub-Saharan Africa. PURPOSE: To compare rates of stroke admissions and case fatality between corresponding periods in 2020 and 2019, within a hospital system in Ghana, to assess the potential impact of the COVID-19 pandemic. METHODS: We compared monthly stroke admissions and mortality rates between January to June 2020 vs. January to June 2019 at the Komfo Anokye Teaching Hospital, a tertiary medical center in Ghana. Predictors of in-patient mortality were assessed using a multivariate logistic regression model. RESULTS: Stroke admissions were higher in January to June 2020 vs. January to June 2019 (431 vs. 401), an increase of +7.5% (95% CI: 5.1-10.5%). There was also a rise in recurrent stroke admissions in 2020 vs. 2019 (19.0% vs. 10.9%, p = .0026). Stroke case fatality trended higher in 2020 vs. 2019 (29.3% vs. 24.2%, p = .095) with an adjusted odds ratio of 1.22 (95% CI: 0.89-1.68). CONCLUSION: While an influence of secular trends cannot be excluded, the COVID-19 outbreak coincided with a comparatively significant rise in initial and recurrent stroke admissions at this Ghanaian tertiary hospital. Continued surveillance at this hospital, as well as assessment of this issue at other sites in Africa is warranted.

Unraveling the Ethical, Legal, and Social Implications of Neurobiobanking and Stroke Genomic Research in Africa: A Study Protocol of the African Neurobiobank for Precision Stroke Medicine ELSI Project.

The ethical, legal, and social implications (ELSI) of emerging neurobiobanks and data resources are unclear in an African scientific landscape with unique cultural, linguistic, and belief systems. The overarching goal of the African Neurobiobank for Precision Stroke Medicine-ELSI Project is to identify, examine, and develop novel approaches to address ELSI issues of biobanking and stroke genomic research in sub-Saharan Africa (SSA). To accomplish the goal we will (1) explore knowledge, attitude, perceptions, barriers, and facilitators influencing ELSI issues related to biobanking and stroke genomic research; (2) use information obtained to craft a community intervention program focused on ELSI issues; and (3) build capacity and careers related to genomics and biobanking for effective client/community engagement while enhancing regulatory, governance, and implementation competences in biobanking science in SSA. A community-based participatory research and mixed-methodological approach, focused on various levels of the social ecological model, will be used to identify and examine relevant ELSI issues. Contextual intervention tools, platforms, and practices will be developed to enhance community understanding and participation in stroke biobanking and genomics research activities while facilitating enduring trust, and equitable and fair utilization of biobanking resources for genetic and trans-omics research. A concurrent capacity building program related to genetic counseling and biobanking will be implemented for early career researchers. The huge potential for neurobiobanking and genomics research in Africa to advance precision medicine applicable to stroke and other neurological disorders requires addressing ELSI challenges while building sustainable research, career, and regulatory capacities in trans-omics and biobanking science.

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-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.