A Smartphone Intervention to Improve Adherence to Antipsychotic Medications

描述(申请人提供)：高达60%的精神分裂症患者没有按照处方服用抗精神病药物，这可能导致症状复发、功能下降、住院和医疗费用增加。最近对利用行为定制、环境支持和药物监测进行的基于患者和药物的干预措施的研究表明，在改善抗精神病药物的依从性方面有希望。然而，仍然需要有效的提高依从性的干预措施(AEI)，这种干预措施的资源密集度较低，更广泛地适用于需要药物管理援助的广泛个人。在过去的十年里，互联网和蜂窝通信的技术进步，包括移动智能手机的出现，已经彻底改变了我们社会的交流方式。尽管各种基于移动电话的应用程序已被证明对改善健康状况有效，如对一些疾病的用药依从性，但很少有针对精神分裂症患者的此类应用程序开发。因此，为了响应NIMH PAR-09-173，我们建议开发和试点测试移动智能手机干预的效果，MedActive，在这一人群中提高抗精神病药物的依从性。我们使用信息-动机-行为(IMB)坚持技能模型作为理论框架来解释MedActive的概念化。IMB技能模型假设，信息灵通且有坚持动机的人将制定与坚持相关的行为技能，从而导致坚持行为和良好的健康结果。MedActive将为患者提供个性化的提醒，让他们按处方服用抗精神病药物，并询问他们服用药物的意图、副作用的发生以及阳性精神病症状的存在。这些对依从性、症状和副作用的生态瞬时评估的摘要将通过电话提供给个人和他们的精神科医生，通过安全的在线临床医生界面。使用迭代的以用户为中心的设计方法，这项建议的具体目标是：(1)与精神分裂症患者、精神病学家和一个专家咨询小组合作开发MedActive的初始版本；(2)在10名精神分裂症患者及其精神病学家中进行实验室可用性测试和短期现场试验，以确定MedActive在临床实践中的初步可接受性和可行性；以及(3)进行MedActive的随机试点试验，与在40名精神分裂症患者及其精神病学家中单独提供智能手机进行比较，以评估其在抗精神病药物依从性方面的效果。我们还将探索精神症状和神经心理障碍是否会缓和MedActive对依从性的影响。如果被证明是有效的，MedActive将在精神分裂症患者的药物自我管理和临床医生的治疗监测方面引入一种范式转变。

DESCRIPTION (provided by applicant): Up to 60% of individuals with schizophrenia do not take their antipsychotic medications as prescribed, which can lead to symptom relapse, decreased functioning, hospitalization, and increased healthcare costs. Recent studies of both patient- and pharmacy-based interventions utilizing behavioral tailoring, environmental supports, and medication monitoring have shown promise in improving antipsychotic adherence. However, there is continued need for effective adherence-enhancing interventions (AEIs) that are less resource intensive and more widely accessible by the broad range of individuals in need of assistance with medication management. Over the last decade, technological advances in internet and cellular communication, including the emergence of mobile 'smartphones', have revolutionized the way our society communicates. Whereas a variety of mobile phone-based applications have been shown to be effective for improving health outcomes such as medication adherence for a number of medical conditions, few such applications have been developed for individuals with schizophrenia. Therefore, in response to NIMH PAR-09-173, we propose to develop and pilot test the effect of a mobile smartphone intervention, MedActive, on improving antipsychotic adherence among this population. We used the Information-Motivation-Behavioral (IMB) Skills Model of adherence as the theoretical framework to inform the conceptualization of MedActive. The IMB Skills Model posits that individuals who are well-informed and motivated to adhere will enact adherence-related behavioral skills that lead to adherence behaviors and favorable health outcomes. MedActive will provide personalized reminders to patients to take their antipsychotic medications as prescribed and will query them about their intentions to take the medication, the occurrence of side effects, and the presence of positive psychotic symptoms. Summaries of these ecological momentary assessments of adherence, symptoms, and side effects will be made available to the individual on the phone and to their psychiatrist through a secure, online clinician interface. Using an iterative user-centered design approach, the specific aims of this proposal are to (1) collaborate with individuals with schizophrenia, psychiatrists and an expert advisory group to develop the initial version of MedActive; (2) conduct laboratory usability testing and a short-term field trial in 10 individuals with schizophrenia and their psychiatrists to determine the preliminary acceptability and feasibility of MedActive in clinical practice; and (3) conduct a randomized pilot trial of MedActive compared to providing a smartphone alone in 40 individuals with schizophrenia and their psychiatrists to evaluate its effect on antipsychotic adherence. We will also explore whether psychiatric symptoms and neuropsychological impairments moderate the effect of MedActive on adherence. If shown to be effective, MedActive will introduce a paradigm shift in medication self-management by individuals with schizophrenia and in treatment monitoring by their clinicians.