Couriel 1999.
| Methods | STUDY DESIGN: Parallel group randomised controlled trial
LOCATION, NUMBER OF CENTRES: UK, A&E department
DURATION OF STUDY: 12 months Blinding of personnel involved in data collection and ongoing care; outcome assessor blinding could not be ascertained |
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| Participants | N SCREENED: Not reported N RANDOMISED: 128 (intervention: 65; control: 63) N COMPLETED: 123 M= 75 F= 53 MEAN AGE: 9.8 years BASELINE DETAILS: Hospital in previous six months: 23%; school absence in previous six months: 6.75 INCLUSION CRITERIA: 6 to 16 years; attending A&E without requirement for admission EXCLUSION: Not reported | |
| Interventions | EDUCATION GROUP: Structured education programme of 3 home visits at 2 weeks, one month and 3 months after enrolment. Principal aims were to enable recognition of early signs of worsening asthma and commencing appropriate treatment based on individualised written self‐management plan. Peak flow meter and inhaler technique instruction given to child and a parent. Advice given on trigger avoidance and managing asthma in school, on holidays and with exercise. Participants encouraged to discuss concerns about asthma. A work book was designed to reinforce the sessions, and children encouraged to personalise this and use as a record, and a way of identifying their objectives. Each child given written self‐management plan. The plan was reviewed and reinforced at follow‐up sessions. Telephone support was available for children in the intervention group. Setting: Community/home CONTROL GROUP: Children visited at home by a research nurses within 2 weeks of the baseline visit and 3, 6 and 12 months post. No specific advice about managing asthma offered by the research nurse. TREATMENT PERIOD: 3 months FOLLOW‐UP PERIOD: 12 months post baseline |
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| Outcomes | A&E attendance; admission to hospital with asthma symptoms | |
| Notes | Data available on request from study author | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | "The randomisation schedule was developed by computer in blocks of six" |
| Allocation concealment? | Low risk | "As eligible subjects were identified, a sealed numbered envelope allocating subjects to one of the groups was opened by a single person who was not otherwise involved with the study" |
| Incomplete outcome data addressed? All outcomes | Low risk | Data available for 96% of trial population at end of follow up |