ADHERE (Applying Directly observed therapy to HydroxyurEa to Realize Effectiveness)

ADHERE（对 HydroxyurEa 应用直接观察疗法以实现有效性）

• 批准号: 10698769
• 负责人: Susan Creary
• 金额: $ 64.28万
• 依托单位: EMOCHA MOBILE HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698769
• 关键词: Acute; Adherence; Admission activity; Adolescence; Adolescent; Affect; American; Attenuated; Behavior; Blinded; Businesses; Caregivers; Caring; Cellular Phone; Child; Childhood; Chronic; Chronically Ill; Clinical Trials; Data; Directly Observed Therapy; Disease; Effectiveness; Electronic Mail; Electronics; Emergency department visit; Feedback; Funding; Goals; Health; Health Care Costs; Hematological Disease; Hospitalization; Inherited; Intervention; Intervention Studies; Life Cycle Stages; Measures; Methods; Monitor; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Outcome; Participant; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Population; Procedures; Public Health; Qualifying; Randomized; Randomized, Controlled Trials; Records; Research; Research Personnel; Sickle Cell Anemia; Site; System; Telephone; Testing; Therapeutic; Training; Translating; Youth; aged; arm; attentional control; behavior change; behavioral adherence; behavioral outcome; burden of illness; care costs; clinical practice; comorbidity; cost; data access; design; effective therapy; efficacy trial; electronic adherence monitoring; experience; financial incentive; high risk; hydroxyurea; improved; improved outcome; mHealth; patient engagement; preference; public health relevance; recruit; trial comparing; user-friendly; video delivery; young adult

Summary/Abstract: Sickle cell disease (SCD) is a severe inherited blood disorder that leads to frequent acute and costly long-term complications. Hydroxyurea is the primary SCD modifying medication in childhood because studies show that it can reduce acute complications and mitigate costly long-term comorbidities. Hydroxyurea non-adherence is common, however, and a key reason for the limited impact that it has had on the outcomes of youth in clinical practice. Despite the impact that improving hydroxyurea adherence among children and adolescents could have on reducing SCD burden, studies testing adherence-promoting interventions for youth are lacking. Video directly observed therapy (VDOT) is an electronic hydroxyurea adherence-promoting strategy delivered using smartphones and includes reminder alerts, video directly observed therapy by trained observers, encouraging adherence feedback from the observers, and monetary incentives for achieving adherence goals. VDOT has been tested in a single-arm study and showed promising results. Yet, attrition was higher than anticipated due to some dissatisfaction with the previous email platform that was used to deliver VDOT and many participants having inconsistent personal smartphone and cellular data access. Engagement with VDOT was not thoroughly assessed, even though the degree of engagement with VDOT has potential to moderate the impact of the intervention. Aspects of the previous study, including the method used to measure adherence and the non-randomized design also limited the ability to definitively conclude that VDOT improves adherence. Finally, the adherence decline that was observed after VDOT was discontinued without any additional adherence support suggested that additional monitoring and intervention after intensive VDOT may be needed to promote lasting adherence behavior change. This feedback and experience prompted us to partner with emocha Health. This is a small business that has a user-friendly VDOT platform, experience successfully providing VDOT to other chronically ill populations, and an established system to provide intermittent ongoing adherence to support after VDOT to limit attrition, optimize participant engagement, and sustain adherence. Therefore, the primary objective of this proposal is to assess retention and sustained engagement during a pilot RCT comparing VDOT via the emocha Health platform to attention control. We will also explore adolescents’ and caregivers’ needs and preferences for longer-term adherence monitoring and intervention. This application aligns with NHLBI’s goal to optimize therapeutic strategies for SCD as it improving adherence is critically relevant to support life-long healthy behaviors and improve outcomes of these youth.

摘要/摘要： 镰状细胞病（SCD）是一种严重的遗传性血液疾病，经常导致急性且昂贵的长期 并发症。羟基脲是儿童时期的主要SCD修饰药物，因为研究表明它 可以减少急性并发症并减轻昂贵的长期合并症。羟基脲不遵守是 然而，常见，也是它对临床青年结果产生有限影响有限的关键原因 实践。尽管影响了儿童和青少年的羟基脲依从性的影响 为了减少SCD伯恩，缺乏对青年进行依从性促进干预措施的研究。视频 直接观察到的治疗（VDOT）是一种使用的电子羟基脲依从性促进策略 智能手机，包括提醒警报，视频直接观察到训练有素的观察者，鼓励 观察者的依从性反馈，以及实现依从目标的货币激励措施。 VDOT具有 在一项单臂研究中进行了测试，并显示出希望结果。然而，损耗高于预期的 与以前用于交付VDOT的电子邮件平台和许多参与者的不满意 个人智能手机和蜂窝数据访问不一致。与VDOT的互动不是 经过彻底评估，即使与VDOT的参与程度有可能调节影响 干预。先前研究的各个方面，包括用于衡量依从性和 非随机设计还限制了确定包括VDOT提高依从性的能力。最后， 在中止VDOT之后观察到的依从性下降而没有任何额外的依从性 支持表明，可能需要进行密集的VDOT之后的其他监控和干预以促进 持久的依从性行为改变。这种反馈和经验促使我们与Emocha合作 健康。这是一家具有用户友好型VDOT平台的小型企业，成功提供的经验 VDOT对其他慢性病人群，以及已建立的系统，以提供间歇性持续的依从性 在VDOT之后支持以限制流失，优化参与者的参与并维持遵守。因此， 该提案的主要目标是评估飞行员RCT期间的保留和持续参与 通过EMOCHA健康平台将VDOT与注意力控制进行比较。我们还将探索青少年的 护理人员对长期依从性监测和干预的需求和偏好。此应用程序 与NHLBI的目标保持一致，以优化SCD的治疗策略，因为它的依从性是至关重要的 与支持终身健康行为并改善这些年轻人的结果相关。