METHODS: A parallel, open-label, 2-arm prospective, pilot randomised controlled trial was conducted at a long-term stroke service at a university based primary care clinic. All stroke caregivers aged ≥ 18 years, proficient in English or Malay and smartphone operation were invited. From 147 eligible caregivers, 76 participants were randomised to either SRA™ intervention or conventional care group (CCG) after receiving standard health counselling. The intervention group had additional SRA™ installed on their smartphones, which enabled self-monitoring of modifiable and non-modifiable stroke risk factors. The Stroke Riskometer app (SRATM) and Life's Simple 7 (LS7) questionnaires assessed stroke risk and lifestyle practices. Changes in clinical profile, lifestyle practices and calculated stroke risk were analysed at baseline and 3 months. The trial was registered in the Australia-New Zealand Clinical Trial Registry, ACTRN12618002050235.
RESULTS: The demographic and clinical characteristics of the intervention and control group study participants were comparable. Better improvement in LS7 scores were noted in the SRA™ arm compared to CCG at 3 months: Median difference (95% CI) = 0.88 (1.68-0.08), p = 0.03. However, both groups did not show significant changes in median stroke risk and relative risk scores at 5-, 10-years (Stroke risk 5-years: Median difference (95% CI) = 0.53 (0.15-1.21), p = 0.13, 10-years: Median difference (95% CI) = 0.81 (0.53-2.15), p = 0.23; Relative risk 5-years: Median difference (95% CI) = 0.84 (0.29-1.97), p = 0.14, Relative risk 10-years: Median difference (95% CI) = 0.58 (0.36-1.52), p = 0.23).
CONCLUSION: SRA™ is a useful tool for familial stroke caregivers to make lifestyle changes, although it did not reduce personal or relative stroke risk after 3 months usage.
TRIAL REGISTRATION: No: ACTRN12618002050235 (Registration Date: 21st December 2018).
METHODS: In this case-control study, we analyzed data on adult patients aged 18 years and above hospitalized for COVID-19 infection with matched hospitalized controls. The demographic, clinical data and anxiety measures using the Generalized Anxiety Disorder-7 questionnaire were analyzed using univariate and multivariate analysis.
RESULTS: 86.6% in the COVID-19 group had anxiety, significantly higher than 13.4% in the control group (p = 0.001). The COVID-19 group was significantly associated with the GAD-7 severity (p = 0.001). The number of COVID-19 patients in the mild, moderate, and severe anxiety groups was 48 (84.2%), 37 (86%), and 18 (94.7%), respectively. Multiple logistic regression showed significant predictors for anxiety, including COVID-19 diagnosis and neurological symptoms. Anxiety was found 36.92 times higher in the patients with COVID-19 compared to those without COVID-19 (OR 36.92;95% CI 17.09, 79.78, p = 0.001). Patients with neurological symptoms were at risk of having anxiety (OR 2.94; 95% CI 1.03, 8.41, p = 0.044).
DISCUSSION: COVID-19 patients experience a significant disruption in psychosocial functioning due to hospitalization. The burden of anxiety is notably high, compounded by a diagnosis of COVID-19 itself and neurological symptomatology. Early psychiatric referrals are warranted for patients at risk of developing anxiety symptoms.
AIMS: To characterize variability of rtPA price, its availability, and its association with and impact on each country's health expenditure (HE) resources.
METHODS: We conducted a global survey to obtain information on rtPA price (50 mg vial, 2020 US Dollars) and availability. Country-specific data, including low, lower middle (LMIC), upper middle (UMIC), and high-income country (HIC) classifications, and gross domestic product (GDP) and HE, both nominally and adjusted for purchasing power parity (PPP), were obtained from World Bank Open Data. To assess the impact of rtPA cost, we computed the rtPA price as percentage of per capita GDP and HE and examined its association with the country income classification.
RESULTS: rtPA is approved and available in 109 countries. We received surveys from 59 countries: 27 (46%) HIC, 20 (34%) UMIC, and 12 (20%) LMIC. Although HIC have significantly higher per capita GDP and HE compared to UMIC and LMIC (p < 0.0001), the median price of rtPA is non-significantly higher in LMICs (USD 755, interquartile range, IQR (575-1300)) compared to UMICs (USD 544, IQR (400-815)) and HICs (USD 600, IQR (526-1000)). In LMIC, rtPA cost accounts for 217.4% (IQR, 27.1-340.6%) of PPP-adjusted per capita HE, compared to 17.6% (IQR (11.2-28.7%), p < 0.0001) for HICs.
CONCLUSION: We documented significant variability in rtPA availability and price among countries. Relative costs are higher in lower income countries, exceeding the available HE. Concerted efforts to improve rtPA affordability in low-income settings are necessary.
OBJECTIVES: The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC "Triple Pill," three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH.
DESIGN: An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130-160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety.
RESULTS: Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required sample size should be achieved by 2024.
CONCLUSION: Low-dose Triple Pill BP lowering could improve long-term outcome from ICH.