Rise-HP: Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis; A Stakeholder Engaged Intervention to Improve Health-Related Quality of Life

Rise-HP：重新构想对过敏性肺炎的支持和教育干预措施；

• 批准号: 10427983
• 负责人: Kerri Aronson
• 金额: $ 17.32万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10427983
• 关键词: Address; Advisory Committees; American; Antigens; Anxiety; Attitude; Behavior Therapy; Behavioral; Benchmarking; Chest; Chronic Disease; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Development; Development Plans; Disease; Education; Educational Intervention; Effectiveness; Effectiveness of Interventions; Exposure to; Extrinsic allergic alveolitis; Feeling; Focus Groups; Foundational Skills; Foundations; Fright; Frustration; Future; Goals; Health; Home environment; Hybrids; Infrastructure; International; Interstitial Lung Diseases; Intervention; Investigation; Knowledge; Knowledge acquisition; Lead; Learning; Life Style; Measures; Medicine; Mental Depression; Mentors; Observational Study; Outcome; Outcomes Research; Participant; Patient Education; Patient Outcomes Assessments; Patient-Centered Care; Patient-Focused Outcomes; Patients; Peer Group; Persons; Protocols documentation; Psychometrics; Qualitative Research; Randomized Controlled Trials; Research; Research Design; Research Methodology; Research Personnel; Review Literature; Sampling; Scientist; Self Efficacy; Site; Social isolation; Societies; Source; Statistical Data Interpretation; Surveys; System; Testing; Thinness; Training; Uncertainty; Universities; Virginia; Visit; Work; acceptability and feasibility; attentional control; career; career development; coping; design; effectiveness implementation trial; effectiveness testing; evidence base; experience; fibrotic interstitial lung disease; health related quality of life; implementation outcomes; implementation science; improved; innovation; instrument; novel; patient oriented; peer; peer coaching; pilot test; preference; randomized trial; recruit; retention rate; skills; theories; therapy development; virtual; web site

Project Summary/Abstract Hypersensitivity Pneumonitis (HP) is an often incurable and potentially progressive fibrotic interstitial lung disease (ILD) with limited treatment options that leads to poor health-related quality of life (HRQOL). Patients with HP experience a profound lack of knowledge about the disease, uncertainty, intense hypervigilance, feelings of anxiety and depression, and marked disruption to their lifestyle and home environment. HRQOL is highlighted by the American Thoracic Society as a priority patient-centered endpoint in ILD research. Despite this, no interventions have been designed to improve the HRQOL of patients living with HP, highlighting a crucial gap in patient centered care. The objective of this proposal is to develop and pilot test a behavioral and educational intervention (“Reimagining Interventions for Support and Education in HP: “RISE-HP”) that targets the key domains of HP-HRQOL and patient knowledge as an innovative strategy to improve the lives of patients with HP. I hypothesize an intervention that delivers peer coaching using cognitive behavioral principles combined with theory-driven patient education will improve HRQOL of patients with HP. To accomplish this objective, I propose the following research aims: 1.) Determine the barriers and facilitators of improving HP- specific HRQOL, patient perceived knowledge gaps, and stakeholder preferences to inform the framework for the RISE-HP intervention 2.) Develop and iteratively refine the novel RISE-HP intervention with stakeholder input. 3.) Conduct a pilot randomized controlled trial to determine the feasibility and acceptability of the RISE- HP intervention. I will work closely with a patient advisory committee through all Aims of the proposal. Findings from this study will lay the groundwork for a multi-center randomized controlled trial to test the effectiveness of the RISE-HP intervention. I will expand on my prior training in observational study design and analysis to develop foundational skills to become an independent investigator with expertise in stakeholder-engaged intervention development, qualitative research methods, behavioral and educational interventions, and conduct of real-world clinical trials with assessment of implementation outcomes. I will be mentored by three internationally recognized clinician scientists, Dr. Monika Safford, Dr. Fernando Martinez, and Dr Robert Kaner. Together we designed a career development plan for me to gain skills through experiential leaning by carrying out the research aims supplemented by didactic work and additional career development benchmarks. By conducting the proposed research, I will advance toward my long-term career goal of becoming an independent investigator focused on patient-centered outcomes research in ILD, specifically by developing and testing interventions that improve HRQOL. This proposal will advance the ILD field by developing a novel patient-centered intervention aimed at improving HRQOL of patients with HP and allow me to build the first HP- specific multisite infrastructure for a larger national hybrid type I effectiveness-implementation trial.

项目概要/摘要 过敏性肺炎 (HP) 是一种常常无法治愈且可能进行性纤维化的间质性肺病 疾病（ILD）的治疗选择有限，导致健康相关的生活质量（HRQOL）较差。 患有 HP 的人对这种疾病缺乏了解，不确定性，高度警惕， 焦虑和抑郁的感觉，以及对他们的生活方式和家庭环境的显着破坏。 尽管这一点被美国胸科学会强调为 ILD 研究中以患者为中心的优先终点。 目前，尚未设计任何干预措施来改善 HP 患者的 HRQOL，这凸显了 该提案的目标是开发和试点测试一种行为和护理方法。 教育干预措施（“重新构想 HP 支持和教育干预措施：“RISE-HP”） HP-HRQOL 和患者知识的关键领域作为改善患者生活的创新策略 我加强了一项干预措施，利用认知行为原则提供同伴辅导。 结合理论驱动的患者教育将改善 HP 患者的 HRQOL 来实现这一目标。 为了实现这一目标，我提出以下研究目标： 1.) 确定改善 HP-的障碍和促进因素 具体的 HRQOL、患者感知的知识差距和利益相关者的偏好为框架提供信息 RISE-HP 干预措施 2.) 与利益相关者一起开发并迭代完善新颖的 RISE-HP 干预措施 3.) 进行试点随机对照试验以确定 RISE-的可行性和可接受性。 惠普干预。我将与患者咨询委员会密切合作，完成该提案的所有目标。 这项研究将为多中心随机对照试验奠定基础，以测试其有效性 我将把我之前在观察性研究设计和分析方面的培训扩展到 RISE-HP 干预。 培养基本技能，成为一名具有利益相关者参与专业知识的独立调查员 干预发展、定性研究方法、行为和教育干预以及行为 我将接受三名实际临床试验的指导并评估实施结果。 国际公认的临床科学家莫妮卡·萨福德博士、费尔南多·马丁内斯博士和罗伯特·卡纳博士。 我们一起为我设计了一个职业发展计划，通过体验式学习来获得技能 制定研究目标，并辅以教学工作和其他职业发展基准。 通过进行拟议的研究，我将朝着成为一名 独立研究者专注于 ILD 中以患者为中心的结果研究，特别是通过开发和 该提案将通过开发一种新颖的方法来推进 ILD 领域的发展。 以患者为中心的干预措施旨在改善 HP 患者的 HRQOL，并让我能够建立第一个 HP- 用于更大规模的国家混合型 I 型有效性实施试验的特定多站点基础设施。