Peng 2014.
Study characteristics | ||
Methods | RCT Unit of randomisation: hospital |
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Participants | Place of recruitment: hospital Numbers randomised: total ‐ participants 3821; I: 1795; C:2026, hospitals I: 23; C: 24 Completing final follow‐up: 1 hospital withdrew before the study began Inclusion criteria: > 18 years old, proven ischaemic stroke confirmed by CT or MRI, TIA, hospitalisation within 30 days after the index event; clinical stability, independence in daily activities Exclusion criteria: CT/MRI evidence of intracerebral haemorrhage, stroke/TIA unrelated to atherosclerosis, severe co‐morbid illness/unstable medical condition, significant memory/behavioural disorders requiring daily care, concurrent participation in another clinical trial, pregnancy Type of stroke (%): not reported Mean age (SD): I: 61.48 (11.47); C: 60.36 (11.66) Gender (% men): I: 67 C: 69 Ethnicity: not reported Socio‐economic or socio‐demographic status: not reported |
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Interventions | Intervention details (components, length, frequency): the intervention consisted of lifestyle modification with the patients, including smoking cessation, healthy diet, and regular exercise. Patient education included an interactive website based education session emphasising the importance of adhering to the SMART program including information discussing risk‐factor control through medication and lifestyle changes Location: outpatient Mode of delivery: outpatient and online Personnel responsible for delivery: clinical researcher Timing post‐stroke: within 30 days Control: participants "received only those interventions chosen by their attending neurologist‐clinician, without the use of the algorithm or interactive education and access to the educational website" |
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Outcomes | 12 months: medication adherence | |
General Information | Funding: funded was provided by the National Key Technology Research and Development Program in the 11th 5‐year plan of China Country of origin: China Publication language: English and Chinese |
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Notes | Analysis method: linear regression model Risk of bias: Unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple cluster sampling method applied |
Allocation concealment (selection bias) | High risk | Concealment was not discussed therefore assumed no blinding occurred |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Does not discuss missing data |
Selective reporting (reporting bias) | Low risk | Study protocol has been published in a previous publication |
Other bias | Unclear risk | Unclear if recurrent events were presented as number of events rather than number of people with one or more event |