Prospective 12-week Randomized Controlled Trial (RCT) of Remotely- Delivered Customized Adherence Enhancement for Poorly Adherent Individuals With Schizophrenia (CAE-S) vs Enhanced Treatment as Usual (eTAU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks
研究概览
简要总结
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).
详细描述
Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
- •Prescribed an antipsychotic medication for treatment of schizophrenia
- •Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month)
- •Ability to be rated on psychiatric rating scales
- •Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation
- •Able to provide written, informed consent to study participation
- •Has access to electronic device and internet to complete sessions conducted on videoconferencing platform
排除标准
- •Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
- •Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
- •Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
- •Immediate risk of harm to self or others
- •Female who is currently pregnant or breastfeeding
结局指标
主要结局
Average Number of CAE-S Sessions Attended by Those in the CAE-S Group After 12 Weeks
时间窗: 12 weeks
Percentage of Subjects in the CAE-S Group That Agree or Strongly Agree That the Intervention Was Useful at 12 Weeks
时间窗: 12 weeks
次要结局
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score Between CAE-S and eTAU Groups at 12 Weeks(12 weeks)
- Change in Tablets Routine Questionnaire in the Past 7 Days (TRQ) at 12 Weeks(12 weeks)
- Change in Tablets Routine Questionnaire in the Past 30 Days (TRQ) at 12 Weeks(12 weeks)
- Change in eCAP Use in the Past Week at 12 Weeks(12 weeks)
研究者
Martha Sajatovic
Physician, UHMG
University Hospitals Cleveland Medical Center