Interventions for Adherence to Oral Antipsychotic Medications in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Social and Occupational Functioning Assessment Scale (SOFAS) Scores
研究概览
简要总结
This study will determine the comparative effectiveness of two systems designed to improve medication adherence in people with schizophrenia.
详细描述
Schizophrenia is a severely debilitating mental disorder. People with schizophrenia often experience unusual thoughts or perceptions, decreased pleasure in everyday life, and difficulty functioning in social situations. Antipsychotic medications have been shown to be effective in improving the symptoms of schizophrenia. Poor adherence to medication, however, leads to re-hospitalization, impedes the process of recovery, and contributes to the high costs associated with schizophrenia treatment. Studies have shown that PharmCAT, cognitive adaptive training that specifically targets medication adherence, has been effective in improving adherence and outcomes in people with schizophrenia. The Med-eMonitor™ is a new pill device that is able to alert patients when they should take medication, when they are taking the wrong medication, and when they are taking medication at the wrong time. The device can also record side effect complaints and then send stored information to treatment staff. The capabilities of the Med-eMonitor™ eliminate the need for the weekly home visits that are necessary in the PharmCAT program, and may make treatment more easily available to individuals in remote or rural settings. This study will compare the effectiveness of PharmCAT, the Med-eMonitor™, and standard treatment in improving medication adherence and treatment outcome in people with schizophrenia.
Participants in this study will be randomly assigned to one of the following treatment groups: (1) PharmCAT; (2) the Med-eMonitor™; or (3) standard treatment. Participants in Group 1 will receive weekly home visits from a case manager. These visits will specifically target medication adherence. Participants in Group 2 will use the Med-eMonitor™ device. Data recorded by the device will be sent electronically to study staff. Participants in Group 3 will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function. The device will record only when medication is taken. All participants will report to the study site at study entry and Months 4, 7, and 10 for measures of symptoms, functioning, social activities, and relationships.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria, as determined on the basis of the Structured Clinical Interview for Diagnosis (SCID-P)
- •Receiving treatment with an oral atypical antipsychotic medication other than clozapine (e.g., risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, or others as they are FDA approved)
- •Assumes some responsibility for taking own medications
- •Able to provide evidence of a stable living environment (e.g., individual apartment, family home, or board and care facility) within 3 months prior to study entry and no plans to move in the next year
- •Intact visual and auditory ability as determined by a computerized screening battery
- •Ability to read at the 5th grade level or higher based upon score on the Wide Range Achievement Test (WRAT)
- •Able to understand and complete rating scales and neuropsychological testing
- •Working telephone present in the home
排除标准
- •History of significant head trauma, seizure disorder, or mental retardation
- •Alcohol or drug abuse or dependence within 3 months prior to study entry
- •Currently being treated by an assertive community treatment (ACT) team
- •History of violence within 1 year prior to study entry
- •Any hospitalizations within 3 months prior to study entry
结局指标
主要结局
Social and Occupational Functioning Assessment Scale (SOFAS) Scores
时间窗: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)
Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes
Adherence
时间窗: Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)
Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.
次要结局
- Schizophrenia Symptoms(Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment))
研究者
Dawn Velligan
Clinical Professor Department of Psychiatry
The University of Texas Health Science Center at San Antonio