NCT07101094招募中不适用
Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 31
- 主要终点
- Participant medication preference as assessed by the Preference of Medication (POM) questionnaire
研究概览
简要总结
The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged ≥18 years at index date.
- •Have a confirmed diagnosis of schizophrenia before index date.
- •Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.
- •Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
- •Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).
- •English or Spanish speaking.
排除标准
- •Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.
- •Evidence of use of XT prior to time of eligibility screening.
研究组 & 干预措施
Participants receiving xanomeline and trospium chloride (X/T) therapy
干预措施: xanomeline and trospium chloride (X/T) therapy (Drug)
结局指标
主要结局
Participant medication preference as assessed by the Preference of Medication (POM) questionnaire
时间窗: Month 1, Month 3, Month 6
Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)
时间窗: Baseline, Month 1, Month 3, Month 6
次要结局
- Reasons for treatment discontinuation(Month 1, Month 3, Month 6)
- Treatment switch plan as described by the treating physician(Baseline, Month 1, Month 3, Month 6)
- Number of participants who are prescribed a treatment dose change(Month 1, Month 3, Month 6)
- Participant baseline demographics(Baseline)
- Treatment titration plan as described by the treating clinician(Baseline, Month 1, Month 3, Month 6)
- Treatment dose prescribed(Baseline, Month 1, Month 3, Month 6)
- Concomitant medication prescribed(Baseline, Month 1, Month 3, Month 6)
- Participant baseline clinical characteristics(Baseline)
研究者
研究点 (31)
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