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.

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.

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.