Skip to main content
. 2018 May 7;2018(5):CD009103. doi: 10.1002/14651858.CD009103.pub3

Boter 2004.

Study characteristics
Methods RCT
Unit of randomisation: participant
Participants Place of recruitment: 2 university hospitals; 10 general hospitals
Numbers randomised: total: 536 (I: 263; C: 273)
% Completing final follow‐up: 91%
Inclusion criteria: TIA, ischaemic stroke, primary intracerebral haemorrhage, or subarachnoid haemorrhage; Dutch‐speaking; ≥ 18 years; first admission for stroke or TIA; hospitalisation within 72 hours after onset of symptoms; life expectancy > 1 year; Rankin grade 0 to 3; discharged home
Type of stroke: TIA (I: 9%; C: 8%); ischaemic stroke (I: 53%; C: 55%); haemorrhagic stroke (I: 10%; C: 9%); subarachnoid haemorrhage (I: 19%; C: 19%)
Median age (IQR): I: 66 (52 to 76); C: 63 (51 to 74)
Gender (% women): I: 51%; C: 52%
Ethnicity (% African American): I: 17%; C: 15%
Socio‐economic or socio‐demographic status:
  • Education level: I: primary school or less ‐ 24%, secondary school ‐ 60%, higher education or university – 15, unknown ‐ 1%; C: primary school or less ‐ 27%, secondary school ‐ 58%, higher education or university ‐ 15%, unknown < 1%

  • Living alone: I: 30%, C: 26%

Interventions Intervention details (components, length, frequency): participants and their carers received 3 telephone calls from a stroke nurse at 1 to 4, 4 to 8 and 18 to 24 weeks; participants received 1 home visit from a stroke nurse at 10 to 14 weeks; checklists used to address stroke risk factors, stroke consequences and unmet needs in terms of stroke services; nurses supported participants and carers according to their individual needs
Location: community
Mode of delivery: home visits and telephone follow‐up
Personnel responsible for delivery: stroke nurses trained for 2 days on "secondary prevention of stroke, rehabilitation, therapies, prognosis and knowledge of local care facilities"
Timing post‐stroke: post‐discharge
Control: standard care
Outcomes 6 months: proportion of participants using secondary prevention drugs (anticoagulants or antiplatelets)
General Information Funding: clinical investigator grant from the Netherlands Heart Foundation (grant D98.014), by a grant from the Netherlands Heart Foundation and the Netherlands Organization for Health Research and Development (940‐32014), and by a grant from the University Medical Center Utrecht
Country of origin: Netherlands
Publication language: English
Notes Analysis method: stated intention‐to‐treat
Risk of bias: low
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Allocation was done by means of a central telephone service"
Allocation concealment (selection bias) Low risk "Allocation was done by means of a central telephone service"
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing data reported by group
Attrition: I: 32/263 (7 died; 25 declined follow‐up); C:18/273 (5 died; 13 declined follow‐up)
Judgement: reasons for missing data reported and review authors judged that they were unlikely to be related to study outcomes
Selective reporting (reporting bias) Low risk Study protocol available and all outcomes are reported in the pre‐specified way
Other bias Low risk The study appears to be free of other sources of bias