Homer 2000.
Methods | STUDY DESIGN: Parallel group
LOCATION, NUMBER OF CENTRES: USA; primary care clinic at Children's Hospital & affiliated local health centre
DURATION OF STUDY: 10 months No blinding of outcome assessor |
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Participants | N SCREENED: 471 approached N RANDOMISED: 137 (treatment: 76; control: 61) N COMPLETED: 106 M = 95 F = 42 MEAN AGE: 7.4 years BASELINE DETAILS: African American: 61%; private health insurance: 13.3% INCLUSION CRITERIA: 3 to 12 years; any outpatient visits, emergency department visits, or inpatient admissions for asthma during the year prior to enrolment EXCLUSION CRITERIA: Significant co‐morbid lung disease; residence outside of Boston/surrounding communities; involvement in other clinical research in asthma | |
Interventions | EDUCATION GROUP: Interactive educational computer programme imparting knowledge of symptom recognition, identification of allergens, medication use, appropriate use of health services & normal activity. Children exposed to computer programme over 3 visits. Setting: Hospital CONTROL GROUP: Follow up on 3 occasions (usual clinical assessment) TREATMENT PERIOD: 3 visits FOLLOW‐UP PERIOD: 10 months |
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Outcomes | Emergency visits; knowledge; withdrawals; availability of PEF meter | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Computer‐generated randomisation lists at each site; within each site children stratified on age (above or below 7 years of age) |
Allocation concealment? | Low risk | Study assignment contained in sealed, opaque envelope |
Incomplete outcome data addressed? All outcomes | Unclear risk | Available case (assumed) |