Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial)

项目总结 本申请是对NOT-OD-21-020的响应，作为综合支持的补充 背部相关腿痛的生物心理社会自我管理(支持试验，1R34AT011209)。家长试验的重点是 关于评估未来第二阶段多站点随机混合有效性的可行性和完善研究设计- 实施非药物方法治疗慢性背部相关性腿痛的临床试验，目的如下： 目标1：进行规划阶段，以制定详细的协议，培训人员，并确保获得监管批准。我们 将特别重视在SBSM干预中提供以能力为基础的培训。 目标2：通过实现以下方面的预定目标来评估支助试验的可行性： A)通过评估招聘率、入学率和 筛选参与者的观点和观点 B)通过评估可接受性和遵从性，提供实验性和比较性干预措施 干预保真率，以及参与者和提供者的看法 C)通过评估未来临床试验结果措施的随访率来收集数据 通过规划阶段和试点研究，家长研究提供了一个独特和理想的平台 补充目标侧重于促进活动，以吸引代表性不足的人群(例如种族、族裔、性别 在研究过程中，更早和更频繁地使用性别、年龄、收入、教育水平和能力水平)。 补充目标： 1.制定程序和流程，透明地定义研究人员和社区成员的工作方式 共同进行拟议中的研究。基于文献，我们的初步工作和与我们的合作 社区咨询团队，我们将制定清晰明了的操作手册，包括一个协作团队 描述研究人员、社区咨询团队和社区成员将如何合作的宪章 家长审判和更多的。 2.探讨和描述代表人数不足的人口在参与方面遇到的障碍和推动者 在他的背痛研究中。我们将从社区成员(n=30)的样本中收集定性数据 传统上代表不足的群体，并使用已建立的模型和框架进行演绎分析。 3.制定社区知情的研究程序和材料，并评估社区成员和参与者的 他们的观点。使用Aim 2的结果和不断发展的研究文献，我们将使用迭代设计， 开发、实施和评估流程被我们的团队成功使用，以创建招聘、筛选、 招生、干预、监测和传播过程和材料，具有文化敏感性并符合 参与CIH疼痛研究的不同参与者需求。

PROJECT SUMMARY This application is submitted in response to NOT-OD-21-020 as a supplement to the Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial, 1R34AT011209). The parent trial focuses on assessing the feasibility and refining the study design for a future phase II multisite randomized hybrid effectiveness- implementation clinical trial on non-drug approaches for chronic back-related leg pain and has the following aims: AIM 1: To conduct a Planning Phase to develop detailed protocols, train personnel, and secure regulatory approvals. We will place special emphasis on providing competency-based training in the SBSM intervention. AIM 2: To assess feasibility of the SUPPORT trial through achievement of pre-specified targets for: a) Recruiting and enrolling individuals with chronic BRLP by assessing recruitment rates, enrollment rates, and screened participants’ views and perspectives b) Delivering experimental and comparison interventions by assessing acceptability and adherence, provider intervention fidelity rates, and participant and provider views c) Data collection by assessing follow up rates of future clinical trial outcome measures With a planning phase and a pilot study, the parent study provides a unique and ideal platform for addressing supplemental aims focused on elevating activities to engage underrepresented populations (e.g. race, ethnicity, sexual orientation, gender, age, income, education level and ability level) earlier and more frequently in the research process. Supplemental Aims: 1. To develop procedures and processes that transparently define how researchers and community members will work together on the proposed research. Based on the literature, our preliminary work and collaboration with our Community Advisory Team, we will develop clearly articulated manuals of operations, including a collaborative team charter that describes how researchers, a Community Advisory Team, and community members will work together on the parent trial and beyond. 2. To explore and describe the barriers and facilitators underrepresented populations encounter in relation to participating in CIH back pain research. We will collect qualitative data from a sample of community members (n=30) from traditionally underrepresented groups and use deductive analyses using established models and frameworks. 3. To develop community-informed study procedures and materials and assess community members’ and participants’ views of them. Using results from Aim 2, and the evolving research literature, we will use an iterative design, development, implementation and evaluation process successfully used by our team, to create recruitment, screening, enrollment, intervention, monitoring and dissemination processes and materials that are culturally sensitive and meet diverse participant needs in relation to engaging in CIH pain research.