Shames 2004.

Methods	STUDY DESIGN: Parallel group randomised controlled trial LOCATION, NUMBER OF CENTRES: 3 centres serving low‐income families in San Francisco, USA DURATION OF STUDY: 12 months CONCEALMENT OF ALLOCATION: Unclear DESCRIBED AS RANDOMISED: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: DESCRIPTION OF WITHDRAWALS/DROPOUTS: Stated TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT No blinding of outcome assessor
Participants	N SCREENED: Not reported N RANDOMISED: 119 (intervention: 59; control: 60) N COMPLETED: 97 M = 69 F = 50 MEAN AGE: 8 years BASELINE DETAILS: Hispanic: 57%; African American: 21%; Medicaid: 71.5%; INCLUSION CRITERIA: Moderate‐severe asthma; low‐income family; 5 to 12 years; covered by state health insurance or eligible for state insurance; history of asthma > 6 months; hospitalisation or > 2 ED visits for asthma in previous year EXCLUSION CRITERIA: Children under the care of allergist/pulmonary specialist
Interventions	EDUCATION GROUP: Disease management programme including assignment to a case manager who delivered a 3‐session course. Case manager also maintained dialogue over 32 weeks of study. Participants also given computer game aimed to improve asthma; 2 visits to specialist; telephone advice line staffed 18 hours/day by specialists. Setting: Home CONTROL GROUP: Usual care and non‐violent computer game TREATMENT PERIOD: 32 weeks (duration of availability of case manager) FOLLOW‐UP PERIOD: 12 months
Outcomes	ED visits; symptoms; lung function; quality of life; knowledge scores
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Block randomisation to generate balance between younger and older children
Allocation concealment?	Unclear risk	Information not available
Incomplete outcome data addressed? All outcomes	Unclear risk	Described as intention‐to‐treat; no explicit description of how this population was composed