NCICAS.
| Methods | STUDY DESIGN: Parallel group
LOCATION, NUMBER OF CENTRES: 8 sites located in inner city American conurbations
DURATION OF STUDY: 2 years Outcome assessors were blinded |
|
| Participants | N SCREENED: 2847 N RANDOMISED: 1033 (treatment: 515; control: 518) N COMPLETED: Not clear M = 661 F = 372 MEAN AGE: 7.7 BASELINE DETAILS: African American: 75%; caretaker smokes: 42%; hospitalisation in previous month: 4.5% INCLUSION CRITERIA: English/Spanish‐speaking; 5 to 11 years; physician‐diagnosed asthma; resident in inner city; use 2 or more medications for asthma, asthma hospitalisation and one unscheduled visit for asthma in 6 months prior to study. Alternatively child had to have symptoms for more than 2 days/sleep disruption for more than 2 nights during 2 weeks prior to study entry EXCLUSION CRITERIA: Not stated | |
| Interventions | EDUCATION GROUP: Intervention delivered to caretaker of child by counsellor who encouraged better communication between family and physician. Primary care physician sent asthma care plan, a spacer, a peak flow meter, and asthma guidelines. Caretakers invited to attend 2 group sessions and individual meeting with their counsellor during 2 months after baseline. Group sessions covered triggers, environmental controls, asthma physiology, strategies for problem solving, and communicating with their child's physician. Children participated in group sessions during following 2‐month period. Additionally, bedding provided to families in intervention group & encouraged to minimise exposure to environmental triggers (tobacco and pet exposure). Counsellor maintained contact with families via telephone every 2 months, tailoring contact based on risk assessment (allergen and trigger exposure, access to care, adherence) Setting: Home CONTROL GROUP: Usual care Arrangements made to assign a primary care physician for participants in both the intervention and control groups without one TREATMENT PERIOD: 4 months FOLLOW‐UP PERIOD: 2 years |
|
| Outcomes | Symptoms; ED visits; hospitalisation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Block randomisation within site |
| Allocation concealment? | Unclear risk | Information not available |
| Incomplete outcome data addressed? All outcomes | Unclear risk | Intention‐to‐treat analysis; no explicit description of how data were analysed for hospital contact outcomes |