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临床试验/NCT02865525
NCT02865525已完成不适用

QUILAM : Development and Validation of a Self-administered QUestionnaire to Identify Levers of Adhesion Behavior to Patient's Medication in Order to Adapt the Educational Monitoring

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
282
试验地点
1
主要终点
Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score

研究概览

简要总结

Medication non-adherence is an economic problem and a major public health challenge. Factors influencing medication adherence can be modelled according to five dimensions: disease, medication, patient and its close relatives, demographic and socioeconomic factors and health care system. A tool is needed to qualify medication adherence in order to adapt tailored support for individual patients to promote and optimize adherence to therapy.

The objective of this work is to present the preliminary results of QUILAM project which is divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence in chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during educational interventions.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Patient with at least one of the following pathologies: diabetes type II, COPD, heart failure
  • person available for a follow-up of 1 year
  • Affiliated to the social security or recipient of such a regime

排除标准

  • Persons referred to in articles L1121-5 and L1121-8 in the french public health code
  • Patient who do not speak french

结局指标

主要结局

Number of events 'hospitalization and death' for 2 patient groups defined through the questionnaire QUILAM score

时间窗: 12 month

次要结局

  • Reliability over time of the questionnaire (test-retest J0 - J15)(12 month)
  • Number of clinical events for 2 patient groups(12 month)
  • Feasibility and acceptability of the questionnaire (duration / missing data)(12 month)
  • External construct validity (Girerd, SatMedQ, BMQ)(12 month)
  • Number of events 'hospitalization and death' for 2 patient groups separate with different cut off(12 month)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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