MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS)

MUSIC 疗法解决镰状细胞病生活质量问题的多部位可行性 (MULTI-MUSIQOLS)

• 批准号: 10728452
• 负责人: Jeffery A Dusek
• 金额: $ 60.96万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10728452
• 关键词: Acute Pain; Address; Adoption; Adult; American Society of Hematology; Anxiety; COVID-19 pandemic; California; Cancer Center; Chronic; Clinic; Collaborations; Control Groups; Data; Data Collection; Data Coordinating Center; Development; Education; Educational Intervention; Effectiveness; Enrollment; Etiology; Feasibility Studies; Future; Goals; Guidelines; Health Personnel; Health education; Home; Hybrids; Impaired health; Individual; Intervention; Interview; Longevity; Manuals; Measures; Mental Health; Music; Music Therapy; Nonpharmacologic Therapy; Pain; Pain Management Method; Pain interference; Pain management; Participant; Patient Recruitments; Patients; Persons; Pilot Projects; Population; Preparation; Procedures; Process; Protocols documentation; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Records; Research; Research Priority; Research Project Grants; Screening procedure; Self Efficacy; Sickle Cell Anemia; Site; Sleep disturbances; Social Functioning; South Carolina; Structure; Surveys; Syndrome; Therapeutic Intervention; Universities; University Hospitals; Waiting Lists; chronic pain; chronic pain management; comparison group; data quality; early adolescence; electronic data; feasibility research; health related quality of life; implementation evaluation; implementation facilitators; implementation outcomes; implementation process; improved; intervention delivery; participant retention; pharmacologic; prisma; programs; psychosocial; public health relevance; randomized trial; recruit; response; success; virtual; virtual delivery

Individuals with sickle cell disease (SCD) often endure multiple acute pain crises throughout their lives. The cumulative impact of these crises and physical complications contribute to the emergence of chronic pain syndromes, mental health conditions, and impaired health-related quality of life (HRQoL) in early adolescence that persist through adulthood. In their 2020 pain management guidelines for SCD, the American Society of Hematology acknowledged the limited effectiveness of pharmacologic approaches and the potential benefits of nonpharmacologic integrative approaches such as music therapy (MT). These guidelines identified research priorities including determining which nonpharmacologic therapies are most acceptable and developing manualized, accessible, and developmentally appropriate interventions for chronic SCD pain. In our prior single-site feasibility study, 24 adults with SCD and chronic pain were randomized to receive either an in-person 6-session MT intervention (n = 12) or waitlist control (WLC) (n = 12). We developed procedures for screening, recruitment, retention, and electronic data collection within this randomized controlled trial (RCT). The enrollment rate was 89%, all study measures were completed, and MT participants demonstrated 100% attendance as well as improvements in self-efficacy and HRQoL compared to WLC participants. While results from this pilot RCT are promising, to scale an intervention in preparation for a future, multi-site, pragmatic, definitive RCT, further steps are needed. Furthermore, with MT being increasingly adapted for virtual delivery, including among adults with SCD, trials are needed to investigate the feasibility of hybrid (i.e., one in-person and five virtual sessions) approaches to MT delivery. In this R01, we propose to examine the feasibility of a multi-site study enrolling (1) in-person MT (n=30), (2) hybrid MT (n=30), and (3) hybrid Health Education (HealthEd) (n=30). Our proposal includes the MULTI-MUSIQOLS Data Coordinating Center at University of California Irvine and two recruiting sites: University Hospitals/Case Western Reserve University and Prisma Health/University of South Carolina. A total of 90 subjects will be randomized to either in-person MT, hybrid MT, or hybrid Health Education (HealthED) (1:1:1 allocation) with a focus on feasibility of data collection, participant recruitment, delivery of interventions, and home practice. Our Specific Aims are: AIM 1) conduct a feasibility RCT to examine the data collection processes and intervention (in-person MT, hybrid MT, and hybrid HealthED) implementation overall and across 2 sites; and AIM 2) evaluate the implementation of the in-person MT, hybrid MT, and hybrid HealthED interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews). Successful conduct of the proposed, feasibility RCT will provide the necessary framework for conducting a future, multi-site, pragmatic, RCT of MT compared with HealthED. Completion of the proposed R01 and the subsequent RCT (UG3/UH3) could provide critical evidence to support inclusion of MT as a chronic pain intervention for individuals with SCD and other similar populations.

患有镰状细胞病（SCD）的人一生中通常会忍受多次急性疼痛危机。这些危机和身体并发症的累积影响有助于慢性疼痛综合症，心理健康状况以及与健康相关的生活质量受损（HRQOL）在青春期早期的出现。在其2020年SCD疼痛管理指南中，美国血液学学会承认了药理学方法的有效性以及非药物综合方法的潜在益处，例如音乐疗法（MT）。这些准则确定了研究的优先级，包括确定哪种非药物疗法是最可接受的，并且正在开发手动，可访问且在发育中适当的慢性SCD疼痛干预措施。在我们先前的单位可行性研究中，将24名患有SCD和慢性疼痛的成年人随机分配，以接收面对面的6节MT干预（n = 12）或候补名单控制（WLC）（n = 12）。我们开发了该随机对照试验（RCT）中筛选，招聘，保留和电子数据收集的程序。与WLC参与者相比，入学率为89％，所有研究措施均已完成，MT参与者表现出100％出席率，自我效能感和HRQOL的提高。尽管该试点RCT的结果很有希望，但要扩展干预措施，以准备未来的多站点，务实，确定的RCT，但仍需要进一步的步骤。此外，随着MT越来越适合虚拟分娩，包括在患有SCD的成年人中，需要进行试验，以调查混合动力的可行性（即一种面对面和五个虚拟会话）用于MT交付。在此R01中，我们建议检查招募多站点研究的可行性（1）个人MT（n = 30），（2）混合MT（n = 30）和（3）混合健康教育（健康）（健康）（n = 30）。我们的建议包括加利福尼亚大学尔湾分校的多穆斯科尔斯数据协调中心和两个招聘地点：大学医院/案例西部储备大学和Prisma Health/Prisma Health/South Carolina University。共有90名受试者将被随机分为面对面的MT，混合MT或混合健康教育（健康）（1：1：1）（1：1：1），重点关注数据收集，参与者招聘，干预措施和家庭实践的可行性。我们的具体目的是：目标1）进行可行性RCT，以检查数据收集过程和干预措施（面对面MT，混合MT和Hybrid Healthed）的整体和整个两个地点的实施；目标2）评估使用定量数据（研究记录，利益相关者调查）和定性数据（访谈）的面对面MT，混合MT和混合健康干预措施的实施。与健康相比，拟议的可行性RCT的成功行为将为进行未来，多站点，务实的RCT提供必要的框架。拟议的R01和随后的RCT（UG3/UH3）的完成可以提供关键的证据，以支持将MT纳入SCD和其他类似人群的慢性疼痛干预措施。