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: 10687074
• 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/10687074
• 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; Collaborations; Development; Development Plans; Disease; Education; Educational Intervention; Educational Materials; 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; 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; eHealth; effectiveness testing; effectiveness/implementation trial; evidence base; experience; fibrotic interstitial lung disease; health administration; health related quality of life; implementation evaluation; 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.

项目摘要/摘要 过敏性肺炎(HP)是一种通常无法治愈并有可能进展的纤维性间质性肺。 疾病(ILD)的治疗选择有限，导致与健康相关的生活质量(HRQOL)较低。病人 由于惠普的经验，对这种疾病的知识严重缺乏，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明显破坏。HRQOL是 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。尽管 因此，还没有设计任何干预措施来改善幽门螺杆菌感染者的HRQOL，这突显了 以病人为中心的护理方面的重大差距。这项建议的目标是开发和试行一种行为和 教育干预(《重新想象惠普的支持和教育干预措施：Rise-HP》) HP-HRQOL的关键领域和患者知识作为改善患者生活的创新战略 幽门螺杆菌感染者。我假设了一种使用认知行为原则提供同伴辅导的干预 结合理论指导的患者教育将提高幽门螺杆菌患者的HRQOL。要做到这一点 目的，提出以下研究目标：1)确定改善惠普的障碍和促进者- 具体的HRQOL、患者感知的知识差距和利益相关者偏好，以告知框架 The Rise-惠普干预2。)与利益相关者一起开发和迭代改进新的Rise-HP干预 输入。3.)进行试点随机对照试验，以确定RISE的可行性和可接受性- 惠普的干预。我将与一个患者咨询委员会密切合作，以实现该提案的所有目标。发现 这项研究将为一项多中心随机对照试验奠定基础，以测试 Rise-惠普的干预。我将扩展我以前在观察性研究设计和分析方面的培训，以 培养基础技能，成为独立调查员，具备利益相关者参与方面的专业知识 干预发展、定性研究方法、行为和教育干预以及行为 评估实施结果的真实世界临床试验。我将由三个人指导 国际公认的临床科学家Monika Safford博士、Fernando Martinez博士和Robert Kaner博士。 我们一起为我设计了一份职业发展计划，通过体验式学习获得技能 制定研究目标，辅以说教工作和额外的职业发展基准。通过 进行拟议的研究，我将朝着我的长期职业目标前进，成为 独立调查者专注于以患者为中心的ILD结果研究，特别是通过开发和 测试改善HRQOL的干预措施。这一提议将通过开发一种新的 以患者为中心的干预措施旨在改善HP患者的HRQOL，并使我能够建立第一个HP- 用于更大的国家混合动力I类有效性的特定多站点基础设施--实施试验。