Randomized Controlled Trial of Migraine Manager: A Digital Therapeutic Self-Management Tool for Adolescents with Migraine

偏头痛管理器的随机对照试验：偏头痛青少年的数字治疗自我管理工具

• 批准号: 10611381
• 负责人: Kevin Hommel
• 金额: $ 53.04万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-26 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10611381
• 关键词: Address; Adherence; Adolescent; Adult; Advanced Practice Nurse; Affect; Aftercare; Age Years; Algorithms; Behavior; Behavior Therapy; Behavioral; Belief; Biometry; Caregivers; Caring; Child; Childhood; Chronic; Clinic; Clinic Visits; Clinical; Clinical Trials; Cognitive Therapy; Collaborations; Computers; Control Groups; Data; Development; Disease; Eating; Education; Effectiveness; Ensure; Exercise; Family; Frequencies; Funding; Habits; Headache; Health; Health Care Costs; Health Services Accessibility; Healthcare; Home; Hydration status; Internet; Intervention; Intervention Studies; Life Style; Life Style Modification; Migraine; Modeling; Monitor; Morbidity - disease rate; Nurses; Opioid; Outcome; Pain management; Parents; Participant; Patients; Persons; Pharmaceutical Preparations; Physical Function; Population; Public Health; Qualifying; Randomized Controlled Clinical Trials; Randomized, Controlled Trials; Recommendation; Reporting; Research; Resources; Self Management; Site; Sleep; Social Functioning; Symptoms; Testing; Time; Training; Treatment Efficacy; Visit; adolescent patient; arm; attentional control; behavior change; biobehavior; clinical effect; cost; digital treatment; disability; economic impact; efficacy evaluation; efficacy testing; evidence base; experience; feasibility trial; follow up assessment; follow-up; forgetting; good diet; handheld mobile device; health care disparity; health related quality of life; improved; medication nonadherence; migraine treatment; neglect; pharmacologic; pilot test; pilot trial; poor health outcome; primary endpoint; recruit; relapse risk; skills; symptom management; tool; treatment effect; treatment planning

Project Summary Poor disease self-management is a significant issue in pediatric migraine as comprehensive treatment for migraine includes pharmacological and biobehavioral interventions as well as consistent engagement in healthy habits (i.e., adequate hydration, eating a healthy and balanced diet, regular exercise, and sufficient sleep), and requires daily patient effort to ensure optimal outcomes. With the annual cost of nonadherence in US health care exceeding $300 billion, self-management of chronic conditions is critical to reducing morbidity and health care expenses. We have identified numerous factors that interfere with adolescents’ ability to effectively self-manage including treatment burden, forgetting, catastrophizing, negative beliefs about treatment efficacy, and lack of parental support/monitoring. Although these barriers are amenable to behavioral intervention/CBT, many adolescents lack the self-management skills to overcome them on their own, and clinic-based self-management efforts have proven inadequate. Through our intervention research, we have demonstrated the efficacy of multicomponent self-management intervention and CBT for migraine treatment. However, the proportion of the migraine population that could receive this type of treatment has been restricted due to limited access (e.g., lack of available trained clinicians, distance between patient homes and treatment facility). With funding from our recent R21 (NS094476) and in collaboration with key stakeholders (i.e., patients, parents, and clinicians), we have addressed these accessibility issues by iteratively developing the first migraine-specific digital therapeutic self-management tool, Migraine Manager, which can be used by all key users to address patient self-management needs. Patients receive algorithmically-derived individualized intervention to meet their needs, and clinicians have access to patient data regarding their symptoms and self- management intervention data that can be obtained prior to or in-between clinic visits. The proposed project aims to conduct a randomized controlled clinical trial to test the effect of the Migraine Manager portal on headache frequency, health-related quality of life, and migraine-related disability in 160 adolescents with migraine compared to an attention control group. We will also test the sustainability of treatment effects through examination of clinical endpoints at 3-, 6-, 9-, and 12-month follow-up, as well as potential mechanisms of observed treatment effects. This study will have a significant impact on public health by providing greater access to an evidence-based resource to a large proportion of patients who otherwise would not receive treatment, thereby reducing health care disparities for families that have limited access to services. Given the health and economic impact of poor self-management in migraine, this study is timely and important, as it has the potential to positively impact health outcomes in this population and serve as a model for self- management intervention across pediatric populations.

项目概要 疾病自我管理不良是小儿偏头痛综合治疗的一个重要问题 偏头痛包括药物和生物行为干预以及持续参与 健康的习惯（即充足的水分、健康均衡的饮食、定期锻炼和充足的饮食） 睡眠），并且需要患者每天尽最大努力来确保结果，并且每年因不遵守治疗而付出的代价。 美国医疗保健超过3000亿美元，慢性病的自我管理对降低发病率至关重要 我们发现了许多干扰青少年能力的因素。 有效的自我管理，包括治疗负担、遗忘、灾难化、消极信念 治疗效果，以及缺乏父母的支持/监督，尽管这些障碍可能会受到行为的影响。 干预/CBT，许多青少年缺乏自我管理技能来克服它们，并且 通过我们的干预研究，基于临床的自我管理努力已被证明是不够的。 证明了多成分自我管理干预和 CBT 对偏头痛治疗的功效。 然而，能够接受此类治疗的偏头痛人群比例受到限制 由于访问受限（例如，缺乏受过训练的婴儿、患者家与治疗之间的距离） 设施）由我们最近的 R21 (NS094476) 提供资金并与主要利益相关者（即， 患者、家长和圣徒），我们通过迭代开发解决了这些可访问性问题 第一个针对偏头痛的数字治疗自我管理工具 Migraine Manager，可供所有人使用 满足患者自我管理需求的关键用户。 干预以满足他们的需求，前沿可以获取有关患者症状和自我治疗的数据 可以在诊所就诊之前或期间获得的管理干预数据。 旨在进行一项随机对照临床试验，以测试偏头痛管理器门户网站对 160 名患有偏头痛的青少年的头痛频率、与健康相关的生活质量以及与偏头痛相关的残疾 我们还将测试治疗效果的可持续性。 通过检查 3、6、9 和 12 个月随访的临床终点以及潜在的 观察到的治疗效果的机制，这项研究将对公众健康产生重大影响。 为大部分患者提供更多获得循证资源的机会 得不到治疗，从而减少获得服务机会有限的家庭的医疗保健差距。 鉴于偏头痛自我管理不良对健康和经济的影响，这项研究是及时且重要的， 因为它有可能对这一人群的健康结果产生积极影响，并可作为自我保健的典范 对儿科人群的管理干预。