Development, Usability Evaluation, and Pilot Feasibility Study of an mHealth Application Supporting Self-Management of Accidental Bowel Leakage, "I'M ABLe"

项目摘要 数以百万计的美国人遭受着意外肠漏(ABL)和与此相关的深刻耻辱 慢性健康问题。ABL对个人和家庭关系、日常活动、幸福感、 和生活质量。对可见的污垢和气味的担忧会造成情绪困扰，减少参与 公共生活和社交活动，并在工作中增加压力。老年人没有能力自我管理ABL 通常会导致养老院入院。ABL保守治疗的成功有赖于自身 由患者按照知情的医疗保健提供者推荐的计划进行管理(SM)。 然而，在目前的实践中，明显缺乏支持ABL患者SM的资源。长期的 本研究的目的是通过支持SM和SM来减轻ABL的严重性和症状，并提高生活质量 促进与医疗保健(HC)提供者关于ABL SM的有效沟通。我们的第一个具体目标是 开发和评估移动健康(MHealth)应用程序(APP)作为干预支持的可用性 自我管理的ABL，指的是“我能”。该应用程序将基于SM理论进行开发， ABL治疗的循证建议，ABL患者的意见，调查人员，和 MHealth应用程序可用性专家和经验丰富的技术人员；该应用程序将成为一个成熟的、私人的、 一家专注于SM的成熟、成功的公司的安全可靠的系统，它将快速跟踪其 随后的可获得性、分配和吸收。可用性将在设计期间通过后评估 使用来自受试者体验、自我报告结果工具和分析的标准数据部署应用程序 在该应用程序中，检查结果，如可学习性、效率、错误和满意度。第二个目标是 使用随机对照设计进行一项初步研究，以检查招募、随机、 并保留受试者并收集有关未来SM结果(SM激活、SM支持和ABL状态)的数据 APP干预效果的临床试验。试点研究中的受试者将被随机分配到 通常护理(他们的HC提供者推荐的ABL管理计划)，没有APP或通常护理 应用程序的附加使用时间为8周。这项建议涉及国家发展战略计划的优先事项 美国国立卫生研究院护理研究所为改善慢性健康状况的SM策略 患者的生活质量。这项建议在应用最先进的方法和前沿方面具有创新性 技术和设计，以开发高度个性化的干预措施，解决医疗保健方面的重大差距 适用于ABL患者。这项提案的结果有可能通过填补 在支持SM和改善更多患者的ABL结果方面存在差距。

Project Summary Millions of Americans suffer from accidental bowel leakage (ABL) and the profound stigma associated with this chronic health problem. ABL negatively impacts personal and family relationships, daily activities, well-being, and quality of life. Worry about visible soiling and odor creates emotional distress, reduces participation in public life and social events, and adds stress during work. The inability of older adults to self-manage ABL often results in nursing home admission. The success of conservative management of ABL depends on self- management (SM) by the patient guided by a plan recommended by an informed healthcare provider. However, in current practice there is a notable lack of resources to support patient SM of ABL. The long-term goal of this research is to reduce ABL severity and symptoms and improve quality of life by supporting SM and promoting effective communication about ABL SM with healthcare (HC) providers. Our first specific aim is to develop and evaluate the usability of a mobile health (mHealth) application (app) as an intervention supporting self-management of ABL, referred to as “I’M ABLe.” The app will be developed based on SM theory, evidenced-based recommendations for ABL management, and input of patients with ABL, investigators, an mHealth app usability expert, and experienced technical staff; the app will be part of an established, private, secure, reliable system of an established, successful company focused on SM, which will fast-track its subsequent availability, distribution, and uptake. Usability will be evaluated during design through post- deployment of the app using standard data from subject experience, self-report outcome tools and analytics from the app, examining outcomes such as learnability, efficiency, errors, and satisfaction. The second aim is to conduct a pilot study using a randomized controlled design to examine the feasibility to recruit, randomize, and retain subjects and collect data on SM outcomes (SM activation, SM support, and ABL status) for a future clinical trial of the effectiveness of the app intervention. Subjects in the pilot study will be randomly assigned to usual care (their HC provider recommended ABL management plan) without the app or usual care with addition of the app use for 8 weeks. This proposal addresses the priority of the strategic plan of the National Institute of Nursing Research, NIH, for improving SM strategies of chronic health conditions to improve patients’ quality of life. This proposal is innovative in applying a state-of-the-art approach and leading edge technology and design to develop a highly personalized intervention that will resolve a significant gap in care for patients with ABL. The outcome of this proposal has potential to transform clinical care for ABL by filling the gap in supporting SM and improving ABL outcomes for more patients.