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临床试验/NCT03809325
NCT03809325已完成不适用

Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

Janssen-Cilag International NV41 个研究点 分布在 7 个国家目标入组 225 人开始时间: 2018年11月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
225
试验地点
41
主要终点
Participant's Experience with PP3M Treatment

研究概览

简要总结

The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a diagnosis of schizophrenia (according to International Classification of Diseases [ICD]-10)
  • Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
  • Have the required language skills to participate in the online questionnaire, in the opinion of the physician
  • Be able and willing to provide their informed consent for study participation

排除标准

  • Has received involuntary treatment with PP3M
  • Was switched to PP3M treatment within a clinical trial

研究组 & 干预措施

Participants with Schizophrenia

No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable.

干预措施: Paliperidone Palmitate 3-Month Formulation (PP3M) (Drug)

结局指标

主要结局

Participant's Experience with PP3M Treatment

时间窗: 1 day

Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.

次要结局

  • Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)(1 day)
  • Responses to the Questionnaires(1 day)
  • Clinical Global Impression-Severity (CGI-S) Score(1 day)
  • European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score(1 day)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (41)

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