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.

项目概要 高达 42% 的美国人患有胃食管反流病 (GERD)，患有不受控制的慢性疾病 降低与健康相关的生活质量并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。该提案旨在改善 通过利用患者的积极性和激励行为改变来改善 GERD 患者的健康结果 移动医疗 (mHealth) 问题提示列表 (QPL) 干预框架。患者激活 强调患者在管理医疗保健方面的知识、技能和信心，并预测患者的健康状况 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。 患者积极性低导致药物治疗依从性差。值得注意的是，很少有研究 专注于开发一种干预措施，以提高 GERD 患者的积极性并激励其行为改变。 新出现的证据表明有效的医患沟通干预措施，例如针对特定疾病的干预措施 QPL，提高患者的积极性。该提案的目标是应用以用户为中心的 5 步设计 开发、完善和测试专门针对 GERD 患者的基于 QPL 的移动应用程序的思维模型 “食道-Qs。”中心假设是 Esophagus-Qs 将可用并有潜力利用 激活患者并激发行为改变。我们的具体目标包括： 1) 开发设计 Esophagus-Qs 通过共情、定义患者面临的问题并构思解决方案； 2） 通过原型设计和可用性测试来完善 Esophagus-Qs 的设计； 3) 收集初步数据 一项随机对照试点研究中的 Esophagus-Qs 旨在估计干预措施的效果大小。我们将 使用定性和定量方法的创新组合来实现这些目标 实施科学为应用程序开发提供信息。拟议的研究意义重大，因为它 利用患者积极性和激励行为改变的潜力，这可以转化为改善健康状况 结果。它还具有重要意义，因为它将开发一个可以扩展以开发移动医疗的平台 其他食管疾病中的 QPL。这项工作的近期预期成果是开发一个可用的 食道-Qs 并收集有关患者活动随时间、药物治疗差异的初步数据 Esophagus-Qs 与标准之间的依从性、健康相关的生活质量以及 GERD 症状严重程度 关心。该职业发展奖的试点数据将成为 R01 资助的临床试验的基础 在大量不同人群中严格测试 Esophagus-Qs 的功效。