跳至主要内容
临床试验/NCT02299154
NCT02299154Unknown不适用

Study of Memory Problems Perceptions With the French Adaptation of the Illness Perception Questionnaire Memory, Among Patients Who Come for the First Time at a Memory Center Until Diagnosis Disclosure Post-visit

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
250
试验地点
2
主要终点
Memory problems perceptions of patients and next of kin during diagnosis process

研究概览

简要总结

This study aims to prospectively examine the memory problem perceptions of patients with memory complaints [MCs] and their accompaniers during the diagnostic process.

详细描述

Through the french adaptation of the "illness perception questionnaire memory", this study aims to prospectively examine the memory problem perceptions of patients with memory complaints [MCs] and their accompaniers during the diagnostic process. The investigators plan to recruit 125 patients with MCs who come for the first time at the Research and Resources Memory Center in Nancy, France. Participants have to express MCs and must be free of dementia diagnosis at the first visit. Participants also need to be accompanied by an accompanier and both have to be fluent in French. This study has been approved by our local Ethics Committee (Committee for the Protection of Persons) and the French Health Security Agency. After giving their informed consent, patients and accompaniers are followed up throughout the diagnostic process with three visits : at their first visit, at one month after the first visit, and at six months after the diagnosis disclosure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • For patients with memory complaints:
  • Age over 18 years
  • Have a memory complaints with a QPC score greater than or equal to 3
  • Be accompanied by a next of kin
  • Folstein MMSE greater than or equal to 15/30
  • Have given their written consent after receiving clear and intelligible oral and written information
  • Social security coverage
  • For Accompaniers :
  • Age over 18 years
  • Consent to participate at the study with the patient
  • Have given their written consent after receiving clear and intelligible oral and written information
  • Social security coverage
  • Be in contact with the patient at least 8 hours per week. It could be physical contact or telephone contact.

排除标准

  • For patients with memory complaints:
  • Sensory deficit interfering with the completion of the questionnaires
  • Level of French insufficient to complete the questionnaires
  • Legally protected person
  • Diagnosis of neurocognitive disorders already established
  • Treatment for Alzheimer Disease
  • Refusal or inability to obtain written informed consent form from the patient
  • Included in another experimental study at inclusion visit
  • For Accompaniers:
  • Sensory deficit interfering with the completion of the questionnaires
  • Level of French insufficient to complete the questionnaires
  • Refusal or inability to obtain written informed consent form from the accompanier

结局指标

主要结局

Memory problems perceptions of patients and next of kin during diagnosis process

时间窗: Baseline and 6 months after diagnosis disclosure

How patients and accompaniers perceive memory problems at the first visit in a Memory Center to 6 months after the diagnosis disclosure, with the Illness Perception Questionnaire Memory

次要结局

  • Psychometric properties of the french adaptation of the Ilness Perceptions Questionnaire - Memory (IPQ-M, Hurt et al. 2010)(Baseline, 1 month later and 6 months after diagnosis disclosure)
  • Impact of the memory problems perceptions on mood and well-being(Baseline and 6 months after diagnosis disclosure)
  • Differences of memory problems perceptions and coping according to level of cognitive disorder at the Mini-Mental State Examination (MMSE)(Baseline and 6 months after diagnosis disclosure)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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