背景:建议制定治疗哮喘急性发作的书面行动计划(WAP)。
目的:我们比较了通过智能手机Web应用程序(app)结合纸质WAP访问的数字行动计划(DAP)对计划外医疗联系人(UMC)的影响与单独使用相同WAP的影响。
方法:这是随机的,未失明,多中心(医生在私人办公室和公立医院进行离线招聘),平行组试验纳入了儿童(6~12岁)或成人(18~60岁)的哮喘患者,这些患者在前一年至少经历过一次严重加重.他们以1:1的比例随机分配至WAP或DAP+WAP。DAP(全自动)根据恶化的严重程度和先前的药物治疗提供治疗建议。DAP是记录3到9个临床描述符的算法。使用该应用程序时,参与者首先以10分量表评估当前症状的严重程度,然后输入症状描述符.在试验(DAP开发)之前,这些描述符的措辞及其顺序已由50名哮喘儿童的父母和50名哮喘成人的父母进行验证;该应用程序在试验期间未进行修改。参与者在三点时接受了采访,六,九,和12个月来记录恶化,UMCs,以及WAP和DAP的使用,包括主观评价(可用性,有用性)的行动计划,一个研究护士。
结果:二百八十名参与者被随机分组,其中33人由于随机分组后没有随访数据而被排除。留下247名参与者(93名儿童,154名成年人)。WAP组有123名参与者(45名儿童,平均年龄8.3±2.0岁;78名成年人,36.3±12.7岁)和DAP+WAP组124名参与者(48名儿童,9.0±1.9岁;76名成年人,34.5±11.3年)。总的来说,年重度加重率为0.53,两组参与者无差异.WAP组的平均UMC数量/年为0.31±0.62,DAP+WAP组为0.37±0.82(平均差,0.06;95%置信区间,-0.12至0.24,P=.82)。对于WAP,每位至少有一次中度或重度恶化的患者的使用量较高(对于DAP,33/65对15/63,P=.002)。因此,尽管两种行动计划的主观评价无显著差异,但与DAP相比,参与者更有可能使用WAP.参与者自我评估的恶化症状严重程度中位数为4/10,与应用评估的症状严重程度没有显着差异。
结论:DAP的使用频率低于WAP,并且与单独使用WAP相比,没有减少UMC的数量。这并不质疑行动计划及其相关治疗教育的兴趣。远程医疗在哮喘护理中的益处仍有待证明。
背景:ClinicalTrials.gov标识符:NCT02869958。
A written action plan (WAP) for managing asthma exacerbations is recommended.
We aimed to compare the effect on unscheduled medical contacts (UMCs) of a digital action plan (DAP) accessed via a smartphone web app combined with a WAP on paper versus that of the same WAP alone.
This randomized, unblinded, multicenter (offline recruitment in private offices and public hospitals), and parallel-group
trial included children (aged 6-12 years) or adults (aged 18-60 years) with asthma who had experienced at least 1 severe exacerbation in the previous year. They were randomized to a WAP or DAP+WAP group in a 1:1 ratio. The DAP (fully automated) provided treatment advice according to the severity and previous pharmacotherapy of the exacerbation. The DAP was an algorithm that recorded 3 to 9 clinical descriptors. In the app, the participant first assessed the severity of their current symptoms on a 10-point scale and then entered the symptom descriptors. Before the
trial, the wordings and ordering of these descriptors were validated by 50 parents of children with asthma and 50 adults with asthma; the app was not modified during the
trial. Participants were interviewed at 3, 6, 9, and 12 months to record exacerbations, UMCs, and WAP and DAP use, including the subjective evaluation (availability and usefulness) of the action plans, by a research nurse.
Overall, 280 participants were randomized, of whom 33 (11.8%) were excluded because of the absence of follow-up data after randomization, leaving 247 (88.2%) participants (children: n=93, 37.7%; adults: n=154, 62.3%). The WAP group had 49.8% (123/247) of participants (children: n=45, 36.6%; mean age 8.3, SD 2.0 years; adults: n=78, 63.4%; mean age 36.3, SD 12.7 years), and the DAP+WAP group had 50.2% (124/247) of participants (children: n=48, 38.7%; mean age 9.0, SD 1.9 years; adults: n=76, 61.3%; mean age 34.5, SD 11.3 years). Overall, the annual severe exacerbation rate was 0.53 and not different between the 2 groups of participants. The mean number of UMCs per year was 0.31 (SD 0.62) in the WAP group and 0.37 (SD 0.82) in the DAP+WAP group (mean difference 0.06, 95% CI -0.12 to 0.24; P=.82). Use per patient with at least 1 moderate or severe exacerbation was higher for the WAP (33/65, 51% vs 15/63, 24% for the DAP; P=.002). Thus, participants were more likely to use the WAP than the DAP despite the nonsignificant difference between the action plans in the subjective evaluation. Median symptom severity of the self-evaluated exacerbation was 4 out of 10 and not significantly different from the symptom severity assessed by the app.
The DAP was used less often than the WAP and did not decrease the number of UMCs compared with the WAP alone.
ClinicalTrials.gov NCT02869958; https://clinicaltrials.gov/ct2/show/NCT02869958.