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

支持意外肠漏自我管理的移动医疗应用程序的开发、可用性评估和试点可行性研究，“IM ABLe”

• 批准号: 10322031
• 负责人: DONNA Z BLISS
• 金额: $ 14.87万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-25 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10322031
• 关键词: Address; Admission activity; Affect; Age; American; Caring; Chronic; Clinical; Clinical Trials; Communication; Communities; Data; Development; Diabetes Mellitus; Dimensions; Distal; Effectiveness; Effectiveness of Interventions; Elderly; Electronics; Emotional; Environment; Evaluation; Event; Extravasation; Family; Family Relationship; Feasibility Studies; Fecal Incontinence; Feeling; Fostering; Frequencies; Friends; Frustration; Future; Gastroenterologist; General Population; Goals; Health; Health Personnel; Health Status; Healthcare Systems; Home; Individual; Inflammatory; International; Intervention; Intestines; Learning; Life; Mobile Health Application; Names; National Institute of Nursing Research; Nursing Homes; Odors; Operative Surgical Procedures; Outcome; Outcomes Research; Patient Care; Patient Self-Report; Patients; Personal Satisfaction; Pilot Projects; Privacy; Privatization; Process; Quality of life; Randomized; Research; Research Personnel; Research Proposals; Resources; Risk; Risk Factors; Secure; Self Management; Severities; Soil; Specialist; Strategic Planning; Stress; Stroke; Surveys; Symptoms; Syndrome; System; Technology; Trauma; United States; United States National Institutes of Health; Update; Urinary Incontinence; Vagina; Woman; Work; base; care providers; clinical care; data standards; design; effectiveness clinical trial; effectiveness evaluation; emotional distress; evidence based guidelines; experience; family management; follow-up; improved; innovation; interest; patient oriented; personalized intervention; randomized controlled design; recruit; satisfaction; social; social stigma; sphincter ani muscle structure; success; theories; tool; treatment as usual; treatment planning; uptake; usability

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.

项目摘要 数以百万计的美国人遭受意外肠漏（ABL）和深刻的耻辱与此相关 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。担心可见的污垢和气味会造成情绪困扰，减少参与 公共生活和社会活动，并增加工作压力。老年人无法自我管理ABL 往往导致养老院入院。ABL保守治疗的成功取决于自身因素， 患者在知情医疗保健提供者推荐的计划的指导下进行管理（SM）。 然而，在目前的实践中，明显缺乏支持ABL患者SM的资源。 本研究的目的是通过支持SM和 促进与医疗保健（HC）提供者就ABL SM进行有效沟通。我们的首要目标是 开发和评估移动的健康（mHealth）应用程序（app）的可用性，作为支持 ABL的自我管理，简称为“我ABLE”。该应用程序将基于SM理论开发， ABL管理的循证建议，以及ABL患者、研究者和 mHealth应用程序可用性专家和经验丰富的技术人员;该应用程序将是一个既定的，私人的， 安全，可靠的系统，一个既定的，成功的公司专注于SM，这将快速跟踪其 随后的可用性、分布和吸收。将在设计期间通过后期评估可用性。 使用来自受试者经验、自我报告结果工具和分析的标准数据部署应用程序 从应用程序，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试点研究，以检查招募，随机化， 保留受试者并收集SM结局（SM激活、SM支持和ABL状态）的数据，以供将来使用 应用程序干预有效性的临床试验。初步研究中的受试者将被随机分配至 常规护理（他们的HC提供者推荐的ABL管理计划），不使用应用程序或常规护理， APP使用8周。该提案涉及国家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，以改善 患者的生活质量。这一建议是创新的应用国家的最先进的方法和领先的优势 技术和设计，以开发高度个性化的干预措施，解决护理中的重大差距 这项提案的结果有可能通过填补ABL的临床护理， 在支持SM和改善更多患者的ABL结局方面存在差距。