Methods: We recruited independent patients with clinically confirmed lacunar ischaemic stroke without cognitive impairment to a prospective randomised clinical trial, LACunar Intervention-1 (LACI-1). We randomised patients using a central web-based system, 1:1:1:1 with minimisation, to masked ISMN 25 mg bd, cilostazol 100 mg bd, both ISMN and cilostazol started immediately, or both with start delayed. We escalated doses to target over two weeks, sustained for eight weeks. Primary outcome was the proportion achieving target dose. Secondary outcomes included symptoms, safety (haemorrhage, recurrent vascular events), cognition, haematology, vascular function, and neuroimaging. LACI-1 was powered (80%, alpha 0.05) to detect 35% (90% versus 55%) difference between the proportion reaching target dose on one versus both drugs at 55 patients. Registration ISRCTN12580546.
Findings: LACI-1 enrolled 57 participants between March 2016 and August 2017: 18 (32%) females, mean age 66 (SD 11, range 40-85) years, onset-randomisation 203 (range 6-920) days. Most achieved full (64%) or over half (87%) dose, with no difference between cilostazol vs ISMN, single vs dual drugs. Headache and palpitations increased initially then declined similarly with dual versus single drugs. There was no between-group difference in BP, pulse-wave velocity, haemoglobin or platelet function, but pulse rate was higher (mean difference, MD, 6.4, 95%CI 1.2-11.7, p = 0.02), platelet count higher (MD 35.7, 95%CI 2.8, 68.7, p = 0.03) and white matter hyperintensities reduced more (Chi-square p = 0.007) with cilostazol versus no cilostazol.
Interpretation: Cilostazol and ISMN are well tolerated when the dose is escalated, without safety concerns, in patients with lacunar stroke. Larger trials with longer term follow-up are justified.
Funding: Alzheimer's Society (AS-PG-14-033).
METHODS: This is a quasi-experimental research with prepost test design with control group involving 81 participants per group from two health clinics in Sepang. The primary outcome was a change in the haemoglobin levels following educational intervention. Secondary outcomes include knowledge on anaemia, Health Belief Model (HBM) constructs, dietary iron intake and compliance towards iron supplementation. The intervention group received a HBMbased education intervention programme.
RESULTS: The response rate in the intervention and control group were 83.9% and 82.7% respectively. Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
CONCLUSION: HBM-based health education programme has proven to be effective in improving the haemoglobin levels, knowledge scores, perceived severity scores and compliance level of participants. The study results emphasized on the effectiveness of such an approach, therefore it is recommended that future educational interventions which aim at increasing preventive healthy behaviours in pregnant women may benefit from the application of this model in primary health care settings.
MATERIALS AND METHODS: This was an interventional study involving 382 blood donors who were deferred for low hemoglobin. The donors were divided equally into two groups: a control group and the intervention group. The control group received standard management for low hemoglobin deferral, which includes a short counseling session and a 1-month course of oral iron therapy. The intervention group used a mobile application in addition to standard management. The primary endpoint was the number of blood donors who returned during the 7 months of follow-up. The secondary endpoints were the hemoglobin increment at the first visit after the donors' deferral.
RESULTS: The return rate was higher in the intervention group, with 81.2% of the donors returning in the 7 months of follow-up compared to 66% of the control group (p<0.001). Male and female donors had mean hemoglobin increments of 1.0 g/dL and 0.7 g/dL, respectively, in the intervention group, compared to decrements of 0.2 g/dL and 0.4 g/dL, respectively, in the control group (p<0.001). Multivariable analysis showed a significant association between intervention method, education level and donation status on donor return (p=0.015, p<0.001, and p<0.001, respectively).
DISCUSSION: Higher return rate and greater hemoglobin increase in the interventional group could be attributed to features in the mobile application. Repeat donors had the highest odds of returning to donate, followed by those with a tertiary level of education, and those given the mobile application. This study showed that a mobile application was effective in enhancing donor return and increasing hemoglobin level among deferred blood donors on their first return.