Unité Fonctionnelle de Physiologie-Explorations Fonctionnelles Respiratoires, Institut National de la Santé et de la Recherche Médicale 938, Centre de Recherche Saint Antoine, Hôpital Armand Trousseau, Assistance Publique Hôpitaux de Paris, F-75012, Paris, France.
Service de Pneumologie et Centre de Référence Constitutif des Maladies Pulmonaires Rares, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale 1152, Université Paris Cité, F-75018, Paris, France.
J Med Internet Res. 2023 Jun 29;25:e41490. doi: 10.2196/41490.
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.
建议制定书面行动计划（WAP）来管理哮喘加重。
我们旨在比较通过智能手机网络应用程序访问的数字行动计划（DAP）与纸质 WAP 单独使用对未计划医疗接触（UMC）的影响。
这是一项随机、非盲、多中心（在私人办公室和公立医院进行线下招募）、平行组试验，纳入了过去一年经历过至少 1 次严重哮喘加重的儿童（6-12 岁）或成人（18-60 岁）。他们以 1:1 的比例随机分配到 WAP 或 DAP+WAP 组。DAP（全自动）根据加重的严重程度和之前的药物治疗提供治疗建议。DAP 是一个记录 3 到 9 个临床描述符的算法。在应用程序中，参与者首先在 10 分制上评估他们当前症状的严重程度，然后输入症状描述符。在试验之前，通过 50 名儿童哮喘和 50 名成人哮喘患者的父母验证了这些描述符的措辞和顺序；在试验过程中，应用程序没有修改。研究护士在 3、6、9 和 12 个月时通过访谈记录哮喘加重、UMC 和 WAP 和 DAP 的使用情况，包括行动计划的主观评价（可用性和有用性）。
总共随机分配了 280 名参与者，其中 33 名（11.8%）因随机分配后随访数据缺失而被排除，247 名（88.2%）参与者（儿童：n=93，37.7%；成人：n=154，62.3%）。WAP 组有 49.8%（123/247）的参与者（儿童：n=45，36.6%；平均年龄 8.3，SD 2.0 岁；成人：n=78，63.4%；平均年龄 36.3，SD 12.7 岁），DAP+WAP 组有 50.2%（124/247）的参与者（儿童：n=48，38.7%；平均年龄 9.0，SD 1.9 岁；成人：n=76，61.3%；平均年龄 34.5，SD 11.3 岁）。总的来说，两组参与者的年严重哮喘加重发生率均为 0.53，没有差异。WAP 组每年 UMC 数量的平均值为 0.31（SD 0.62），DAP+WAP 组为 0.37（SD 0.82）（平均差异 0.06，95%CI -0.12 至 0.24；P=.82）。在至少有 1 次中度或重度加重的患者中，使用 WAP 的比例更高（33/65，51%对 15/63，24%；DAP；P=.002）。尽管行动计划的主观评价没有显著差异，但参与者更倾向于使用 WAP 而不是 DAP。自我评估的加重症状严重程度中位数为 4 分，与应用程序评估的症状严重程度无显著差异。
与单独使用 WAP 相比，DAP 的使用频率较低，与 WAP 相比并未减少 UMC 的数量。
ClinicalTrials.gov NCT02869958；https://clinicaltrials.gov/ct2/show/NCT02869958。
