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.

Effect of an Educational Intervention for Primary Stroke Risk Reduction in Ghana and Nigeria: Pilot Randomized Controlled Trial.

BACKGROUND: Using tailored mobile health interventions to improve global vascular risk awareness and control is yet to be investigated for primary stroke prevention in Africa. METHODS: This 2-arm pilot randomized controlled trial involved 100 stroke-free adults with at least 2 vascular risk factors for stroke. Eligible participants were assigned randomly to a control arm offering 1-time counseling (n=50) or a 2-month educational intervention arm (n=50) comprising a stroke video and riskometer app aimed at improving stroke risk factor awareness and health-seeking behavioral modification to control total vascular risk. Reduction in total stroke risk score was the primary outcome while feasibility and process measures were secondary outcomes. RESULTS: All enrolled participants completed the 2-month follow-up (retention rate=100%). The mean (SD) age of participants was 59.5 (±12.5) years, 38% were males. The mean change in stroke risk score at 2 months was -11.9% (±14.2) in the intervention arm versus -1.2% (±9.1) in the control arm, P=0.0001. Stroke risk awareness improved by 16.1% (±24.7) in the intervention arm versus 8.9% (±24.7) in the control arm, P=0.08. The intervention arm had 11.1 mm Hg reduction in systolic blood pressure compared with 4.8 mm Hg reduction in the control arm. CONCLUSIONS: The intervention demonstrated a positive signal of effect over a 2-month period. A definitive clinical trial with a longer duration of follow-up is warranted on the premise of these promising findings from this pilot randomized clinical trial. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05619406.

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.

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.

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.

Pilot trial of a tele-rehab intervention to improve outcomes after stroke in Ghana: A feasibility and user satisfaction study.

BACKGROUND: Tele-rehabilitation after stroke holds promise for under-resourced settings, especially sub-Saharan Africa (SSA), with its immense stroke burden and severely limited physical therapy services. OBJECTIVE: To preliminarily assess the feasibility and outcomes of mobile technology-assisted physical therapy exercises for stroke survivors in Ghana. METHODS: We conducted a prospective, single arm, pre-post study involving 20 stroke survivors recruited from a tertiary medical center, who received a Smartphone with the 9zest Stroke App® to deliver individualized, goal-targeted 5-days-a-week exercise program that was remotely supervised by a tele-therapist for 12 weeks. Outcome measures included changes in stroke levity scale scores (SLS), Modified Rankin score (MRS), Montreal Cognitive Assessment (MOCA), and feasibility indicators. RESULTS: Among study participants, mean ±â€¯SD age was 54.6 ±â€¯10.2 years, 11 (55%) were men, average time from stroke onset was 6 months. No participants dropped out. Compared with baseline status, mean ±â€¯SD scores on SLS improved from 7.5 ±â€¯3.1 to 11.8 ±â€¯2.2 at month 1 (p < 0.0001) and 12.2 ±â€¯2.4 at month 3 (p < 0.0001), MOCA scores improved from 18.2 ±â€¯4.3 to 20.4 ±â€¯4.7 at month 1 (p = 0.14), and 22.2 ±â€¯7.6 at month 3 (p = 0.047). Mean ±â€¯SD weekly sessions performed by participants per month was 5.7 ±â€¯5.8 and duration of sessions was 25.5 ±â€¯16.2 min. Erratic internet connectivity negatively affected full compliance with the intervention, although satisfaction ratings by study participants were excellent. CONCLUSION: It is feasible to administer an m-health delivered physical therapy intervention in SSA, with high user satisfaction. Randomized trials to assess the efficacy and cost-effectiveness of this intervention are warranted.