The current investigation was a nonrandomized, nonstratified, multicenter, real-life study comprising two intervention groups and one control group (Fig 1). The investigation was conducted between July 2001 and December 2002 in 36 study centers nationwide, including general practitioner (GP) and specialist offices as well as asthma outpatient facilities of hospitals.
AU eligible patients were invited to join a standardized patient management program (SPMP). They had the option to self select additional educational activities with the additional IEP, provided that individual access to the Internet was possible at home, at the study centers, or at school. Data collection in the intervention groups was completed at two subsequent visits scheduled at 6 months (visit 2) and 12 months (visit 3) after enrollment. in detail
Due to limited capacities in several study centers, numerous patients were in waiting loops for educational courses. Patients on waiting lists for a future (prescheduled) asthma education program were asked to build the control group (CG). Having consented to take part in the study, these patients were recruited 6 months prior to their scheduled educational intervention. During the 6 months prior to the educational program and during the 6 subsequent months, patient outcomes under usual care were documented. Follow-up of CG patients ended with the initiation of the patient education program after visit 2 (end of waiting period; Fig 1).
At the baseline evaluation (visit 1), information was secured about the child, including recent asthma activity, medication adherence, use of rescue medication, lung function (peak expiratory flow [PEF], FEV1), health-care utilization (eg, number of hospitalizations, number of outpatient visits at GP or specialist, number of emergency visits, medication costs), and quality of life (QoL). Baseline assessment also included demographic characteristics, allergy status, and classification of degree of asthma severity according to national recommendations. At all visits, the identical protocol was used in all study groups.
Figure 1. Course of the trial in the three study groups. The SPMP started within 4 weeks after the baseline visit. Patients in the IEP group went through the SPMP in combination with IEP during the subsequent months.