Department of Psychology, St Jude Children's Research Hospital, Memphis, TN, United States.
Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
JMIR Mhealth Uhealth. 2020 May 8;8(5):e14884. doi: 10.2196/14884.
Sickle cell disease (SCD) is an inherited blood disorder causing acute complications and chronic progressive end organ damage. SCD is associated with significant morbidity, early mortality, impaired health-related quality of life, and increased acute health care utilization. Hydroxyurea is a US Food and Drug Administration-approved medication that reduces disease complications, acute health care utilization, and costs. However, adherence to hydroxyurea is suboptimal. Mobile health (mHealth) interventions have the potential to improve hydroxyurea adherence, but few examples exist that are specific to the SCD population.
This study aimed to design a mHealth intervention for individuals with SCD to improve adherence to hydroxyurea, using a user-centered design that was informed by specific barriers to hydroxyurea adherence and utilization in this population.
This study consisted of 4 phases. In phase 1, individuals with SCD and health care providers participated in an optimization digital workshop. In phase 2, patients completed surveys pertaining to their interest in mHealth use, barriers and facilitators to hydroxyurea use, and health literacy. Phases 3 and 4 involved semistructured interviews and focus groups, respectively, and used the Health Belief Model (HBM) as the framework to investigate drivers of poor hydroxyurea adherence and to inform the development of an app prototype. In addition, in phase 4, we have incorporated the patients' feedback on the preliminary app prototype and its features.
Barriers to hydroxyurea adherence were consistent with the literature and included forgetfulness and several specific thoughts and emotions associated with hydroxyurea use (eg, fear of side effects, depression, stigma, and hopelessness). In addition, more than half of the participants reported potentially low health literacy. Preferred patient app features included 7 key components, namely (1) medication reminders and tracker, (2) disease education, (3) communication, (4) personalization, (5) motivation, (6) support during pain episodes, and (7) social support. Utilizing a user-centered design approach, data obtained from patients and providers were translated into features within the app, mapping to components of the HBM and the specific drivers of hydroxyurea adherence and matching the literacy level of the population, resulting in the development of a novel mobile app called InCharge Health.
The InCharge Health app is an mHealth intervention developed with substantial input from users and by mapping the HBM as the framework that guided the choice for its components. InCharge Health is a customized product for the SCD population aimed at optimizing medication adherence, with the end goal of improving quality of life and health outcomes among patients with SCD. The efficacy and implementation of the InCharge Health app as an mHealth intervention to promote hydroxyurea adherence will be tested in a future stepped-wedge multicenter trial for adolescents and adults with SCD.
镰状细胞病（SCD）是一种遗传性血液疾病，可导致急性并发症和慢性进行性终末器官损伤。SCD 与显著的发病率、早期死亡率、健康相关生活质量受损以及急性医疗保健利用率增加有关。羟基脲是一种获得美国食品和药物管理局批准的药物，可减少疾病并发症、急性医疗保健利用率和成本。然而，羟基脲的依从性并不理想。移动医疗（mHealth）干预措施有可能提高羟基脲的依从性，但针对 SCD 人群的具体示例很少。
本研究旨在设计一种针对 SCD 患者的 mHealth 干预措施，以提高他们对羟基脲的依从性，采用以用户为中心的设计，该设计基于该人群中对羟基脲依从性和使用的具体障碍。
本研究分为 4 个阶段。在第 1 阶段，SCD 患者和医疗保健提供者参加了优化数字研讨会。在第 2 阶段，患者完成了有关他们对 mHealth 使用的兴趣、使用羟基脲的障碍和促进因素以及健康素养的调查。第 3 阶段和第 4 阶段分别涉及半结构化访谈和焦点小组，使用健康信念模型（HBM）作为框架，调查羟基脲依从性差的驱动因素，并为应用程序原型的开发提供信息。此外，在第 4 阶段，我们结合了患者对初步应用程序原型及其功能的反馈。
羟基脲依从性的障碍与文献一致，包括健忘和与羟基脲使用相关的几种特定思想和情绪（例如，对副作用的恐惧、抑郁、耻辱感和绝望感）。此外，超过一半的参与者报告潜在的低健康素养。患者首选的应用程序功能包括 7 个关键组件，即（1）药物提醒和追踪器，（2）疾病教育，（3）沟通，（4）个性化，（5）动机，（6）疼痛发作时的支持，以及（7）社会支持。利用以用户为中心的设计方法，从患者和提供者那里获得的数据被转化为应用程序中的功能，映射到 HBM 的组件以及羟基脲依从性的具体驱动因素，并与人群的识字水平相匹配，从而开发出一种名为 InCharge Health 的新型移动应用程序。
InCharge Health 应用程序是一种 mHealth 干预措施，它得到了用户的大量投入，并以 HBM 为框架进行开发，该框架指导了其组件的选择。InCharge Health 是一种针对 SCD 人群的定制产品，旨在优化药物依从性，最终目标是改善 SCD 患者的生活质量和健康结果。InCharge Health 应用程序作为一种 mHealth 干预措施，以促进羟基脲的依从性，其功效和实施将在未来一项针对青少年和成年 SCD 患者的阶梯式多中心试验中进行测试。
