Baretta Dario, Rüttimann Carole Lynn, Amrein Melanie Alexandra, Inauen Jennifer
Institute of Psychology, University of Bern, Bern, Switzerland.
JMIR Mhealth Uhealth. 2025 Apr 24;13:e57191. doi: 10.2196/57191.
The adoption of protective behaviors represents a crucial measure to counter the spread of infectious diseases. The development of effective behavior change techniques therefore emerged as a public health priority during the COVID-19 pandemic, but randomized controlled trials (RCTs) testing such interventions during the pandemic were scarce. We conducted a Multiphase Optimization Strategy to develop, optimize, and evaluate a smartphone app, Soapp+, to promote hand hygiene during the COVID-19 pandemic.
This RCT aims to evaluate the efficacy of the Soapp+ app (intervention group) targeting motivation and habit compared to a simplified version of the app mainly delivering hand hygiene information (active control group). We hypothesize that, compared to the control group, the intervention group will show greater improvements in hand hygiene behavior and behavioral determinants post intervention and at a 6-month follow-up.
We conducted an RCT from March 2022 to April 2023, recruiting 193 adults living in Switzerland online. Following baseline assessment, the intervention lasted 32 days, followed by a postintervention assessment and a 6-month follow-up. The primary outcome was the change in hand hygiene behavior from pre- to postintervention and preintervention to follow-up. Hand hygiene was assessed with electronic diaries. The intervention group received content incorporating various behavior change techniques designed to address key motivational and volitional determinants of hand hygiene behavior (eg, skills, knowledge, intention, attitudes toward hand hygiene, risk perception, outcome expectancies, self-efficacy, action planning, coping planning, action control, habit). In contrast, the active control group was exposed to behavior change techniques targeting only a subset of these determinants (ie, skills, knowledge, and intention). The delivery of the intervention content was fully automated. Group differences were tested using an intention-to-treat approach with the nonparametric Wilcoxon rank sum test.
Of the 193 randomized participants, 146 completed the first hand hygiene diary preintervention and were included in the main analysis. The mean age was 41 (SD 17) years, and 69.2% (n=101) were women. The main analysis revealed significant superiority of the intervention compared to controls in the change in hand hygiene pre-post intervention (W=2034; P<.04; effect size r=0.17) and between preintervention and follow-up (W=2005; P<.03; effect size r=0.18). Regarding behavioral determinants, the change in coping planning pre-post intervention (W=3840; P=.03, effect size r=0.16) was significantly greater in the intervention group using Soapp+ compared to controls.
Soapp+ was developed through a rigorous experimental method during the ongoing COVID-19 pandemic. The RCT provided evidence for the efficacy of Soapp+ to promote hand hygiene in the context of a pandemic.
ClinicalTrials.gov NCT04830761; https://clinicaltrials.gov/study/NCT04830761.
采取防护行为是应对传染病传播的关键措施。因此，在新冠疫情期间，开发有效的行为改变技术成为公共卫生的优先事项，但在疫情期间测试此类干预措施的随机对照试验（RCT）却很稀少。我们开展了一项多阶段优化策略，以开发、优化并评估一款智能手机应用程序Soapp+，该应用旨在在新冠疫情期间促进手部卫生。
本随机对照试验旨在评估Soapp+应用程序（干预组）针对动机和习惯的效果，与主要提供手部卫生信息的简化版应用程序（积极对照组）进行比较。我们假设，与对照组相比，干预组在干预后及6个月随访时，手部卫生行为及行为决定因素会有更大改善。
我们于2022年3月至2023年4月进行了一项随机对照试验，通过网络招募了193名居住在瑞士的成年人。在基线评估后，干预持续32天，随后进行干预后评估和6个月随访。主要结局是干预前到干预后以及干预前到随访期间手部卫生行为的变化。通过电子日记评估手部卫生情况。干预组接收包含各种行为改变技术的内容，这些技术旨在解决手部卫生行为的关键动机和意志决定因素（如技能、知识、意图、对手部卫生的态度、风险认知、结果期望、自我效能感、行动计划、应对计划、行动控制、习惯）。相比之下，积极对照组仅接触针对这些决定因素子集（即技能、知识和意图）的行为改变技术。干预内容的交付完全自动化。使用意向性分析方法和非参数Wilcoxon秩和检验来检验组间差异。
在193名随机参与者中，146人在干预前完成了第一份手部卫生日记，并被纳入主要分析。平均年龄为41（标准差17）岁，69.2%（n = 101）为女性。主要分析显示，与对照组相比，干预组在干预前后手部卫生变化方面（W = 2034；P <.04；效应大小r = 0.17）以及干预前到随访期间（W = 2005；P <.03；效应大小r = 0.18）具有显著优势。关于行为决定因素，与对照组相比，使用Soapp+的干预组在干预前后应对计划的变化（W = 3840；P =.03，效应大小r = 0.16）显著更大。
Soapp+是在持续的新冠疫情期间通过严格的实验方法开发的。该随机对照试验为Soapp+在疫情背景下促进手部卫生的有效性提供了证据。
ClinicalTrials.gov NCT04830761；https://clinicaltrials.gov/study/NCT04830761
