Harris Katherine, Newby Chris, Mosler Gioia, Steed Liz, Griffiths Chris, Grigg Jonathan
Centre for Genomics and Child Health, the Blizard Institute, Queen Mary University of London, London, UK.
Centre for Primary Care and Public Health, Yvonne Carter Building, Queen Mary University of London, London, UK.
Pilot Feasibility Stud. 2022 Mar 23;8(1):67. doi: 10.1186/s40814-022-01031-1.
Children with poorly controlled asthma have higher rates of unplanned healthcare use and school absences, as well as lower rates of medication adherence and knowledge. They also feel less comfortable using their medication at school, due to social fears and bullying. In this study, this was addressed through two school-based self-management interventions piloted to determine which one to use in a full trial.
We sought to assess the feasibility and acceptability of two school-based self-management intervention aimed at improving asthma control. Schools in London were randomised to (i) a theatre workshop for the whole year group aimed at raising awareness of asthma in schools, followed by self-management workshops for children (full intervention), (ii) theatre workshop alone (theatre only), or (iii) usual care (controls). Opt-out consent was obtained from parents. The study was a cluster randomised pilot trial, using London schools as the unit of allocation. Our primary aim was to assess the feasibility of delivering a self-management intervention in schools aimed at improving the asthma control test (ACT) score at 6 months. Secondary outcomes included acceptability of the school-based interventions, suitability of the theatre intervention and the full intervention with the self-management workshops, and generation of randomised data to inform future power calculations. Data were analysed by generalised mixed-effect models.
The recruitment strategy for this trial was effective. Five schools were randomised to full intervention (189 children), four to theatre only (103 children), and six to controls (83 children). Asthma control test (ACT) score at baseline and 6 months was obtained from 178/358 participating children. Compared with the controls, there were no large differences found in ACT score with the full intervention; knowledge and perception of asthma improved though. GP and hospital visits increased in the full intervention group. Compared with controls, ACT score was unchanged in the theatre only group.
The asthma self-management intervention trial in schools is feasible and acceptable. The full intervention consisting of both theatre and self-management workshop for asthmatics tended to be better suited to improve outcomes than the theatre intervention on its own. This full intervention should be the one carried forward into a main trial if funding for further research was sought. Further work is needed to understand why there was evidence that unscheduled visits to healthcare professionals increased with the full intervention.
The study was registered on the clinical trials database on 14th May 2018 (ID NCT03536416 ).
哮喘控制不佳的儿童非计划性医疗服务使用率和缺课率较高,药物依从性和知识水平较低。由于社交恐惧和欺凌,他们在学校使用药物时也感觉不太自在。在本研究中,通过两项基于学校的自我管理干预措施进行试点,以确定在全面试验中使用哪一项。
我们试图评估两项旨在改善哮喘控制的基于学校的自我管理干预措施的可行性和可接受性。伦敦的学校被随机分为:(i)为整个年级组举办的戏剧工作坊,旨在提高学校对哮喘的认识,随后为儿童举办自我管理工作坊(全面干预);(ii)仅戏剧工作坊(仅戏剧组);或(iii)常规护理(对照组)。获得了家长的退出同意。该研究是一项整群随机试点试验,以伦敦学校作为分配单位。我们的主要目的是评估在学校开展旨在提高6个月时哮喘控制测试(ACT)分数的自我管理干预措施的可行性。次要结果包括基于学校的干预措施的可接受性、戏剧干预以及戏剧与自我管理工作坊全面干预的适用性,以及生成随机数据以指导未来的功效计算。数据采用广义混合效应模型进行分析。
该试验的招募策略有效。五所学校被随机分配到全面干预组(189名儿童),四所学校被分配到仅戏剧组(103名儿童),六所学校被分配到对照组(83名儿童)。从178/358名参与研究的儿童中获得了基线和6个月时的哮喘控制测试(ACT)分数。与对照组相比,全面干预组的ACT分数没有发现大的差异;不过哮喘知识和认知有所改善。全面干预组的全科医生(GP)就诊和医院就诊次数增加。与对照组相比,仅戏剧组的ACT分数没有变化。
学校哮喘自我管理干预试验是可行且可接受的。与单独的戏剧干预相比,由戏剧和哮喘患者自我管理工作坊组成的全面干预似乎更适合改善结果。如果寻求进一步研究的资金,应将这种全面干预推进到主要试验中。需要进一步开展工作,以了解为什么有证据表明全面干预会导致非计划的医疗专业人员就诊增加。
该研究于2018年5月14日在临床试验数据库中注册(ID NCT03536416)。