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

针对背部相关腿痛的综合支持性生物心理社会自我管理（SUPPORT 试验）

• 批准号: 10365290
• 负责人: Gert Bronfort
• 金额: $ 15.37万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10365290
• 关键词: Achievement; Address; Adherence; Administrative Supplement; Advisory Committees; Age; Area; Attention; Back; Back Pain; Bioethical Issues; Bioethics; Chronic; Clinical Research; Clinical Trials; Collaborations; Communities; Competence; Complementary Health; Data; Data Collection; Decision Making; Development; Education; Educational Background; Enrollment; Ensure; Ethnic Origin; Ethnic group; Evaluation; Foundations; Future; Gender; Health; Human Resources; Income; Individual; Integrative Medicine; Intervention; Knowledge; Learning; Literature; Low Back Pain; Low income; Manuals; Methods; Modeling; Monitor; Outcome Measure; Pain; Pain Research; Pain in lower limb; Pain management; Parents; Participant; Phase; Pilot Projects; Policies; Population; Procedures; Process; Protocols documentation; Provider; Race; Randomized; Research; Research Design; Research Personnel; Role; Sampling; Secure; Self Management; Sex Orientation; Social Conditions; Social Justice; Social status; Specific qualifier value; Time; Training; Translations; Trust; Underrepresented Populations; Work; authority; base; behavioral health; biopsychosocial; clinical trial implementation; community based research; community engaged research; community involvement; comparison intervention; disability; effectiveness implementation study; falls; follow-up; health equity; health inequalities; improved; iterative design; member; non-drug; operation; provider intervention; recruit; research study; response; screening; social

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.

项目摘要 该申请是针对NOT-OD-21-020的响应提交的，作为对综合支持的综合支持的补充 背部相关腿痛的生物心理自我管理（支持试验，1R34AT011209）。家长审判重点 评估可行性并完善研究设计的未来II期多站点随机混合有效性 - 针对慢性背部相关腿部疼痛的非药物方法的实施临床试验，并具有以下目的： 目标1：进行计划阶段以制定详细的协议，培训人员和安全的监管批准。我们 将特别强调在SBSM干预中提供基于能力的培训。 目标2：通过实现预先指定的目标来评估支持试验的可行性： a）通过评估招聘率，入学率和 筛选参与者的观点和观点 b）提供者，通过评估可接受性和依从性来提供实验和比较干预措施 干预保真度，参与者和提供者的观点 c）通过评估未来临床试验结果指标的随访率来收集数据 通过计划阶段和试点研究，父母的研究为解决方案提供了独特而理想的平台 补充旨在提升活动以参与代表性不足的人群（例如种族，种族，性行为） 在研究过程中，更早，更频繁地的方向，性别，年龄，收入，教育水平和能力水平）。 补充目的： 1。开发透明地定义研究人员和社区成员如何工作的程序和过程 共同进行拟议的研究。根据文献，我们与我们的初步工作和合作 社区咨询团队，我们将开发清晰明确的操作手册，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共同努力的宪章 家长审判及以后。 2。探索和描述与参与有关 在CIH背痛研究中。我们将从社区成员样本中收集定性数据（n = 30） 传统上，代表性不足的群体并使用既定模型和框架使用演绎分析。 3。开发社区信息的研究程序和材料以及评估社区成员和参与者 他们的观点。利用AIM 2和进化研究文献的结果，我们将使用迭代设计， 我们团队成功使用的开发，实施和评估过程，以创建招聘，筛选， 在文化上敏感并满足的注册，干预，监测和传播过程和材料 潜水员参与者需要与参与CIH疼痛研究有关。