MIST 2014.
Study characteristics | ||
Methods | RCT Unit of randomisation: participant |
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Participants | Place of recruitment: inpatient ward Numbers randomised: total: 386 (I: 193; C: 193) Completing final follow‐up: 86% for systolic BP, 61% for LDL Inclusion criteria: first ever stroke Exclusion criteria: impairment precluding participation (e.g. aphasia, psychiatric conditions, cognitive impairment), unable to converse in English, unable to give consent, other condition likely to affect participation (e.g. significant aphasia), receiving psychiatric/psychological treatment, discharged to hospital/nursing home where medications given by staff or if participation likely to overburden individual Type of stroke: not stated Mean age (SE): not stated Gender (% men): not stated Ethnicity (%) : Maori (I: 10.3 C: 7.2), Pacific Islander (I: 8.8 C: 4.7), Asian (I: 2.1% C: 4.7%), New Zealand European/other (I: 78.8 C: 83.4) Socio‐economic or socio‐demographic status (%):
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Interventions | Intervention details: usual care, in addition to 4 motivational interviewing sessions (at 28 days, 3,6 and 9 months post stroke) ‐ the first session was face‐to‐face either in the participant's home or in hospital and then a further 3 by telephone or face‐to‐face if telephone was not possible. A letter was sent to the participant's GP to remind them of the participant's participation and a reminder of recommendations to monitor BP and lipid Location: secondary care/community Mode of delivery: face‐to‐face and/or telephone follow‐up Personnel responsible for delivery: researcher Timing post‐stroke: started at 28 days post stroke Control: after discharge, participants were followed up by their GP or designated stroke centre every 3 to 6 months as part of the usual stroke care |
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Outcomes | Self‐reported medication adherence at 3, 6 and 9 months; systolic BP at 12 months; LDL, HDL and total cholesterol at 12 months | |
General Information | Funding: funded by the New Zealand Health Research Council (HRC Ref 10/458)
Country of origin: New Zealand Publication language: English |
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Notes | Analysis method: stated intention‐to‐treat Risk of bias: low |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A randomisation technique from a previously published protocol was used |
Allocation concealment (selection bias) | Low risk | Treatment allocation was determined by randomisation and was concealed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Sensitivity analysis was undertaken. Missing data on the primary outcome was imputed using the value carry forward approach |
Selective reporting (reporting bias) | Low risk | The study protocol was published within a previously peer reviewed journal |
Other bias | Low risk | The study appears to be free of other sources of bias |