A Smartphone Intervention to Improve Adherence to Antipsychotic Medications

描述（由申请人提供）：高达60%的精神分裂症患者不按规定服用抗精神病药物，这可能导致症状复发，功能下降，住院治疗和医疗费用增加。最近对利用行为定制、环境支持和药物监测的基于患者和药房的干预措施的研究表明，在提高抗精神病药物依从性方面有希望。然而，仍然需要有效的依从性增强干预措施（AEIs），这些干预措施的资源密集度较低，并且需要药物管理援助的广大个人更广泛地获得。在过去的十年里，互联网和蜂窝通信的技术进步，包括移动的“智能手机”的出现，已经彻底改变了我们社会的沟通方式。尽管各种基于移动的电话的应用程序已被证明可有效改善健康结果，例如许多医疗状况的药物依从性，但很少有此类应用程序被开发用于精神分裂症患者。因此，作为对NIMH PAR-09-173的回应，我们建议开发并初步测试移动的智能手机干预MedActive对改善该人群抗精神病药物依从性的影响。我们使用的信息-动机-行为（IMB）技能模型的坚持作为理论框架，告知MedActive的概念化。IMB技能模型假定，消息灵通和有动力坚持的个人将制定与坚持相关的行为技能，从而导致坚持行为和有利的健康结果。MedActive将向患者提供个性化的提醒，让他们按照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学瞬时评估的总结将通过电话提供给个人，并通过安全的在线临床医生界面提供给他们的精神科医生。使用迭代的以用户为中心的设计方法，本提案的具体目标是（1）与精神分裂症患者、精神科医生和专家咨询小组合作开发MedActive的初始版本;（2）进行实验室可用性测试和简短的-在10名精神分裂症患者及其精神科医生中进行的一项长期现场试验，以确定MedActive在临床中的初步可接受性和可行性实践;和（3）在40名精神分裂症患者及其精神科医生中进行MedActive与单独提供智能手机相比的随机试点试验，以评估其对抗精神病药物依从性的影响。我们还将探讨精神症状和神经心理障碍是否会减轻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中引入范式转变。

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.