Newhouse Nikki, Martin Angela, Jawad Sena, Yu Ly-Mee, Davoudianfar Mina, Locock Louise, Ziebland Sue, Powell John
Nuffield Department of Primary Care Health Sciences, Health Experiences Research Group, University of Oxford, Oxford, UK.
Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
BMJ Open. 2016 Dec 28;6(12):e013401. doi: 10.1136/bmjopen-2016-013401.
To determine the feasibility of a randomised controlled trial (RCT) assessing the effects of an experience-based website as a resource for the self-management of chronic asthma.
Feasibility, single-blind RCT in 2 regions of England. Randomisation used computer-generated random number sequence in a 1:1 ratio, after baseline data collection, to website access for 2 weeks.
Adults (age ≥18 years), with clinically diagnosed asthma as coded in their primary care electronic record, prescribed inhaled corticosteroids for at least 3 months in the previous year, were recruited from 9 general practices.
The EXPERT asthma intervention is an interactive PC/laptop/tablet/smartphone compatible website designed with extensive input from adults with asthma. It provides experience-based information and aims to support subjective perception of self-efficacy, self-management and improve health status.
Primary outcomes were consent/recruitment, website usage and completion of outcome measures. Secondary outcomes included Partners in Health (PIH) questionnaire, the Chronic Disease Self-Efficacy Scale, the SF36 and the E-Health Impact Questionnaire. Participant blinding postrandomisation was not possible. The analysis was blind to allocation.
Recruitment target exceeded. 148 participants randomised (73 intervention group). Age range 19-84 years; 59% female. 121 of 148 (84%; 62 intervention group) followed up. The median number of logins was 2 (IQR 2-3, range 1-48). Minimal differences of change from baseline between groups; both showed improvement in health state or management of their condition with no significant differences between arms. No adverse events.
Recruitment and retention confirmed feasibility. The trends towards improved outcomes suggest that further research on digital interventions based on exposure to others' personal experiences may be of value in the self-management of chronic asthma.
ISRCTN29549695; Results.
确定一项随机对照试验（RCT）的可行性，该试验旨在评估一个基于经验的网站作为慢性哮喘自我管理资源的效果。
在英格兰的2个地区进行的可行性单盲RCT。在收集基线数据后，采用计算机生成的随机数字序列以1:1的比例进行随机分组，干预组可访问网站2周。
从9家全科诊所招募年龄≥18岁、在其初级保健电子记录中被临床诊断为哮喘、前一年至少3个月使用吸入性糖皮质激素治疗的成年人。
EXPERT哮喘干预是一个与个人电脑/笔记本电脑/平板电脑/智能手机兼容的交互式网站，在哮喘成年患者的广泛参与下设计而成。它提供基于经验的信息，旨在支持自我效能感、自我管理的主观认知，并改善健康状况。
主要结局为同意参与/招募、网站使用情况及结局指标的完成情况。次要结局包括健康伙伴（PIH）问卷、慢性病自我效能量表、SF36和电子健康影响问卷。随机分组后无法对参与者进行设盲。分析过程对分组情况设盲。
超过招募目标。148名参与者被随机分组（73名在干预组）。年龄范围为19 - 84岁；59%为女性。148名中有121名（84%；干预组62名）接受随访。登录次数中位数为2次（四分位间距2 - 3，范围1 - 48）。两组间与基线相比的变化差异极小；两组在健康状况或病情管理方面均有改善，两组间无显著差异。无不良事件发生。
招募和保留情况证实了该研究的可行性。结局改善的趋势表明，进一步研究基于他人个人经验的数字干预措施可能对慢性哮喘的自我管理具有价值。
ISRCTN29549695；结果
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