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:
|
|
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 |