Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease

开发、完善和测试胃食管反流病移动健康问题提示表

• 批准号: 10739903
• 负责人: Afrin Kamal
• 金额: $ 19.3万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10739903
• 关键词: Acids; Address; Adherence; American; Barrett Esophagus; Behavioral; Clinical; Clinical Trials; Communication; Communities; Data; Development; Disease; Dose; Empathy; Esophageal Adenocarcinoma; Esophageal Diseases; Esophagus; Face; Feedback; Focus Groups; Foundations; Funding; Future; Gastroenterology; Gastroesophageal reflux disease; Goals; Health; Health Status; Healthcare; Individual; Infrastructure; Intervention; K-Series Research Career Programs; Knowledge; Manuscripts; Measures; Medical; Mentorship; Methodology; Methods; Mobile Health Application; Modeling; Outcome; Paper; Patient-Focused Outcomes; Patients; Physicians; Pilot Projects; Population Heterogeneity; Process; Protocols documentation; Qualitative Methods; Quality of life; Randomized; Research; Resources; Risk; Role; Sampling; Severities; Shapes; Socioeconomic Status; Symptoms; System; Testing; Thinking; Time; Translating; Update; Visit; Work; behavior change; career development; clinical care; community setting; cost; design; effective intervention; efficacy testing; experience; health care service utilization; health related quality of life; ideation; implementation science; improved; innovation; insight; mHealth; medication compliance; mobile application; motivated behavior; persistent symptom; pilot test; primary outcome; prototype; reduce symptoms; secondary outcome; skills; standard of care; success; usability; user centered design

Project Summary Up to 42% of Americans with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms that reduce health-related quality of life and heighten the risk of long-term complications. My long- term goal is to improve health outcomes for patients with esophageal disorders. This proposal aims to improve health outcomes for patients with GERD, by harnessing patient activation and motivating behavioral change as a framework for a mobile health (mHealth) Question Prompt List (QPL) intervention. Patient activation emphasizes patients’ knowledge, skills, and confidence in managing their health care and predicts patients’ level of health success. However, almost half of patients with GERD demonstrate low patient activation scores. Low patient activation leads to poor adherence to medical therapy. Remarkably, very little research has focused on developing an intervention to improve patient activation and motivate behavior change in GERD. Emerging evidence suggests effective patient-physician communication interventions, such as disease-specific QPLs, increase patient activation. The objective of this proposal is to apply a 5-step user-centered Design Thinking model to develop, refine, and test a mobile app based QPL specific for GERD patients titled “Esophagus-Qs.” The central hypothesis is that Esophagus-Qs will be usable and has potential to harness patient activation and motivate behavior change. Our specific aims include: 1) Develop the design of Esophagus-Qs by empathizing, defining the problems patients face, and ideating to generate solutions; 2) Refine the design of Esophagus-Qs by prototyping and testing usability; and 3) Collect preliminary data on Esophagus-Qs in a randomized controlled pilot study to estimate the effect size of the intervention. We will pursue these aims using an innovative combination of qualitative and quantitative methodologies and implementation science to inform app development. The proposed research is significant, because it has potential to harness patient activation and motivate behavior change, that can translate into improved health outcomes. It is also significant because it will develop a platform that can be extended to develop mHealth QPLs in other esophageal disorders. The proximate expected outcome of this work is to develop a usable Esophagus-Qs and collect preliminary data on differences in patient activation over time, medication adherence, health-related quality of life, and GERD symptom severity between Esophagus-Qs and standard of care. Pilot data from this career development award will be the foundation for an R01-funded clinical trial to rigorously test the efficacy of Esophagus-Qs among a large, diverse population.

项目摘要 高达42%的美国胃食管反流病（GERD）患者经历不受控制的慢性 降低健康相关生活质量和增加长期并发症风险的症状。我的长- 长期目标是改善食管疾病患者的健康结果。这项建议旨在改善 GERD患者的健康结果，通过利用患者激活和激励行为改变， 移动的健康（mHealth）问题提示列表（QPL）干预的框架。患者激活 强调患者的知识，技能和管理他们的医疗保健的信心，并预测患者的 健康成功的水平。然而，几乎一半的GERD患者表现出较低的患者激活评分。 低患者激活导致对药物治疗的依从性差。值得注意的是，很少有研究 专注于开发一种干预措施，以改善患者的激活和激励GERD的行为改变。 新出现的证据表明，有效的医患沟通干预措施，如疾病特异性 QPL，增加患者激活。本提案的目标是应用以用户为中心的5步设计 用于开发、完善和测试特定于GERD患者的基于移动的应用程序的QPL的思维模型， “食道-Q”中心假设是，食道-Qs将是可用的，并有潜力利用 患者激活和激励行为改变。我们的具体目标包括：1）开发设计 食管-通过同情，定义患者面临的问题，并构思产生解决方案的问题; 2） 通过原型设计和可用性测试完善食管-Qs的设计;以及3）收集以下方面的初步数据： 食管-Qs在一项随机对照初步研究中估计干预的效应量。我们将 采用创新的定性和定量方法组合来实现这些目标， 实施科学为应用程序开发提供信息。这项研究意义重大，因为它 利用患者激活和激励行为改变的潜力，这可以转化为改善健康 结果。它也很重要，因为它将开发一个平台，可以扩展到发展mHealth 其他食管疾病中的QPL。这项工作的最接近的预期成果是开发一个可用的 食管-Qs，并收集患者激活随时间、药物 食管-Qs和标准之间的依从性、健康相关生活质量和GERD症状严重程度 在乎这项职业发展奖的试点数据将成为R 01资助的临床试验的基础， 在大量不同的人群中严格测试食管-Qs的疗效。