Study design (if review, criteria of inclusion for studies)
Multi-centre parallel RCT
Participants
Children aged 6 - 11 years with CF and their primary caregivers. N = 65 recruited; randomised to the intervention group (n = 33) and a control group (n = 29).
Interventions
Investigating the effectiveness of a self-management education programme called 'Airways'. 2. Control - no treatment (n = 25). 1. 'Airways' - self management programme about aerosol and ACT treatments (20 min) (n = 26).
Outcome measures
1. baseline, post-intervention and 6- and 12-month follow-up time points. 2. caregiver self-management behaviour 3. responsiveness of ACT performance when child unwell 4. child knowledge of ACT 5. child's feelings about regular aerosol and ACT regimens 6. caregiver self-efficacy in managing aerosol and ACT regimens 7. adherence to aerosol and ACT regimens
Main results
The intervention group increased the percentage of prescribed aerosols taken (P < 0.001) and this was maintained at 12-month follow-up (P < 0.001). There was no change in the percentage of prescribed ACT performed, although when the child was unwell, caregivers in the intervention group increased the frequency and/or duration of ACT (P = 0.028) in the per-protocol analysis but not in the intention-to-treat analysis. Children in the intervention group increased their knowledge of ACT (P < 0.001) which was maintained at 12-month follow-up (P < 0.001) and felt more positively about their chest treatment regimens immediately following the intervention (P = 0.017) but not at 12-month follow-up. There were no significant changes in the control group for these variables over time. No significant changes occurred in the caregivers' reports of self-management behaviours and self-efficacy in either group.
Authors' conclusions
The positive results suggest that 'Airways' is a valuable educational tool for primary school-aged children with CF and their caregiver.
Keywords: Caregivers; Child; Inhalation OR nebulised; non pharmacological intervention - psyco-soc-edu-org; pharmacological_intervention; Self-Management; Behavioural interventions;