Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Headache. 2020 Jun;60(6):1103-1110. doi: 10.1111/head.13805. Epub 2020 Apr 22.
The objective of this study was to design, code, and pilot test the feasibility and preliminary efficacy of a self-management digital therapeutic tool for adolescents with migraine.
Self-management of migraine in adolescents is complex and has important implications for health outcomes. A comprehensive and accessible approach to self-management is needed for youth with migraine, their parents, and clinicians.
An iterative co-design process was used to develop and optimize the Migraine Manager's digital therapeutic self-management tool. Subsequently, 40 adolescents, age 11-18 years, were enrolled in an 8-week single-arm open label trial (N = 36 analyzed). The primary outcome was headache days.
Usage data for Migraine Manager were similar to other health app usage data and feedback from participants was uniformly positive, indicating acceptable feasibility. Preliminary efficacy was demonstrated by a reduction in headache days from 17.2 ± 8.5 at baseline to 7.9 ± 7.2 at 8 weeks (95% CI, -13.0 to -7.8; P < .001). There was also statistically significant improvement in patient physical functioning quality of life reported by both patients (baseline = 55.7 ± 20.4; 8 weeks = 69.7 ± 21.9, P = .005) and parents (baseline = 58.5 ± 22.8; 8 weeks = 74.3 ± 18.1, P = .002), and in parent-reported ingestion issues subscale of the adherence barriers scale from baseline to 8 weeks (baseline = 6.0 ± 2.6; 8 weeks = 5.2 ± 3.0, P = .020).
A self-management digital therapeutic tool for adolescents with migraine can offer care to patients who might not otherwise receive such services. Migraine Manager demonstrated the feasibility and preliminary efficacy in this pilot trial, highlighting the potential beneficial impact of this tool. Larger controlled trials with long-term follow-up are needed to definitively determine the clinical efficacy of Migraine Manager.
本研究旨在设计、编写并初步测试一款针对青少年偏头痛的自我管理数字治疗工具的可行性和初步疗效。
青少年偏头痛的自我管理较为复杂，对健康结果具有重要影响。患有偏头痛的青少年及其父母和临床医生需要一种全面且易于使用的自我管理方法。
采用迭代共同设计流程开发和优化偏头痛管理器的数字治疗自我管理工具。随后，招募了 40 名 11-18 岁的青少年参与为期 8 周的单臂开放标签试验（N=36 进行分析）。主要结局指标为头痛天数。
偏头痛管理器的使用数据与其他健康应用程序的使用数据相似，参与者的反馈也一致为积极，表明其具有可接受的可行性。初步疗效表现为头痛天数从基线时的 17.2±8.5 天减少到 8 周时的 7.9±7.2 天（95%CI，-13.0 至-7.8；P<.001）。患者的身体机能和生活质量报告也有统计学意义的显著改善，且由患者（基线=55.7±20.4；8 周=69.7±21.9，P=.005）和父母（基线=58.5±22.8；8 周=74.3±18.1，P=.002）报告。此外，在从基线到 8 周期间，父母报告的依从性障碍量表中摄入问题亚量表也有所改善（基线=6.0±2.6；8 周=5.2±3.0，P=.020）。
针对青少年偏头痛的自我管理数字治疗工具可以为那些可能无法获得此类服务的患者提供护理。偏头痛管理器在本试点试验中表现出了可行性和初步疗效，突出了该工具具有潜在的有益影响。需要进行更大规模的对照试验和长期随访，以确定偏头痛管理器的临床疗效。
