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临床试验/NCT02868307
NCT02868307
Unknown
不适用

Response Shift and Quality of Life in Patients Suffering From Schizophrenia and Their Caregivers

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 200 人2012年7月
适应症Schizophrenia

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Schizophrenia
发起方
Assistance Publique Hopitaux De Marseille
入组人数
200
试验地点
1
主要终点
Numbers of response shift occuring in patients suffering from schizophrenia and in their caregivers
最后更新
9年前

概览

简要总结

Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. A challenge in the interpretation of QoL measures, especially in longitudinal studies, is that QoL is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. An important mediator of this adaptation process is a "response shift" (RS), which involves changing internal standards, values and the conceptualization of QoL. RS can be divided into three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting QoL) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). Patients may change their frame of reference, rendering scores from different measurement occasions incomparable. An RS is a potential explanation when the QoL of an individual who has experienced a serious health event or chronic condition is similar to the QoL of a healthy individual. With an RS, the concept of QoL changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. True change may be over- or underestimated when a RS is present, leading to biased estimates of the magnitude of change.The objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers.

This is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period.

100 patients with schizophrenia and 100 caregivers

Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and CART method.

注册库
clinicaltrials.gov
开始日期
2012年7月
结束日期
2017年1月
最后更新
9年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • 未提供

排除标准

  • Patient suffuring of demencia

结局指标

主要结局

Numbers of response shift occuring in patients suffering from schizophrenia and in their caregivers

时间窗: 12 months

研究点 (1)

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