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，会导致频繁的急性且昂贵的长期治疗 羟基脲是儿童时期主要的 SCD 缓解药物，因为研究表明它可以缓解并发症。 可以减少急性并发症并减轻昂贵的长期合并症。 然而，这很常见，也是其对青年临床结果影响有限的一个关键原因。 尽管提高儿童和青少年的羟基脲依从性可能会产生影响。 对于减轻 SCD 负担，缺乏测试针对青少年的促进依从性干预措施的研究。 直接观察疗法（VDOT）是一种电子羟基脲依从性促进策略，使用 智能手机，包括提醒警报、由训练有素的观察员直接观察治疗的视频，鼓励 VDOT 拥有来自观察员的遵守情况反馈，以及实现遵守目标的金钱激励。 在一项单臂研究中进行了测试，并显示出有希望的结果，但由于人员流失率高于预期。 对之前用于发送 VDOT 的电子邮件平台和许多参与者的一些不满 个人智能手机和蜂窝数据访问不一致并不存在。 尽管 VDOT 的参与程度有可能减轻影响，但仍进行了彻底评估 先前研究的各个方面，包括用于衡量依从性的方法和 非随机设计也限制了得出 VDOT 提高依从性的明确结论的能力。 在没有任何额外依从性的情况下停止 VDOT 后观察到的下降 支持者建议，在强化 VDOT 后可能需要进行额外的监测和干预，以促进 这种反馈和经验促使我们与 emocha 合作。 Health.这是一家拥有用户友好的VDOT平台、成功提供经验的小型企业。 针对其他慢性病人群的 VDOT，以及提供间歇性持续依从性的既定系统 在 VDOT 后提供支持，以限制人员流失、优化参与者参与并维持依从性。 该提案的主要目标是评估试点 RCT 期间的保留率和持续参与度 我们还将通过 emocha Health 平台将 VDOT 与注意力控制进行比较。 护理人员对长期依从性监测和干预的需求和偏好。 符合 NHLBI 优化 SCD 治疗策略的目标，因为提高依从性至关重要 与支持终生健康行为和改善这些青少年的成果有关。