Ellis 2005.
| Study characteristics | ||
| Methods | RCT Unit of randomisation: participant |
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| Participants | Place of recruitment: hospital TIA clinic or geriatric medical day hospital Numbers randomised: total: 205 (I: 100; C: 105) % Completing final follow‐up: 94% Inclusion criteria: < 3 months since stroke, TIA or amaurosis fugax; ambulant patients; one of more cardiovascular risk factor (high BP, history of current smoking, high cholesterol, diabetes) Exclusion criteria: cognitive impairment (AMT < 5 on screening) Type of stroke: TIA (I: 29%; C: 26%); stroke (I: 61%; C: 65%) Mean age (95% CI): I: 64.3 (62.4 to 66.1), C: 65.8 (64.0 to 67.5) Gender (% men): I: 54%; C: 50% Ethnicity: not reported Socio‐economic or socio‐demographic status: not reported |
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| Interventions | Intervention details (components, length, frequency): monthly reviews (approximately 3) with a stroke nurse specialist; participants received tailored verbal and written information addressing medication compliance, lifestyle modification, interaction with medical services, risk factor status and risk factor targets; participants advised to visit their GP if risk factors poorly controlled Location: hospital outpatient setting Mode of delivery: outpatient appointment Personnel responsible for delivery: stroke nurse specialist Timing post‐stroke: first review at 3 months Control: usual care (1 review in hospital outpatient setting where patients received standard outpatient advise on risk factors and secondary prevention; discharged to general practice care) |
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| Outcomes | 5 months (per protocol): SBP; DBP; total cholesterol; HbA1c; combined risk factor control 3.6 years (additional follow‐up): SBP; DBP; total cholesterol; HbA1c; persistence with therapy; self‐reported adherence; recurrent cardiovascular events; percentage of patients meetings target for combined risk factor control |
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| General Information | Funding: educational grant from Servier Laboratories Country of origin: UK Publication language: English |
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| Notes | Analysis method: stated intention‐to‐treat Risk of bias: unclear |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomly allocated to treatment or control groups using a computer‐generated random sequence" |
| Allocation concealment (selection bias) | Low risk | "Concealed in sequentially numbered opaque sealed envelopes" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data reported by group Attrition: I: 6 lost to follow‐up (reasons unclear); C: 7 lost to follow‐up (reasons unclear) Excluded from analysis: I: 3 patients entered twice by error: duplicate results excluded from the analysis; C: 1 patient found to be ineligible: results included in the analysis (intention‐to‐treat) Judgement: reasons for missing data reported and review authors judge that they are unlikely to be related to study outcomes |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information (protocol not obtained) |
| Other bias | Low risk | The study appears to be free of other sources of bias |