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临床试验/NCT03681899
NCT03681899已完成不适用

Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older

University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2018年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
289
试验地点
1
主要终点
Estimate the rupture of galenic prevalence of at least one molecule in a population of subjects aged 65 years or over living at home and taking at least one oral drug for 2 weeks or more.

研究概览

简要总结

Elderly people frequently take several medications and are exposed to iatrogenic risks.

The oral route is the preferred route of administration. The effectiveness and the safety of the drugs depend in particular on the modes of administration (frequency of the intake, respect of the doses and the galenic ...).

However, these modalities are very little known concerning the treatments intake at home in the elderly population.

In a health facility welcoming geriatric patients, the rupture of galenic is frequent and favored by swallowing disorders, dependence, the increase in age, the presence of cognitive disorders or psycho-behavioral disorders.

The consequences of the rupture of galenic are numerous, concern the patients but also the caregivers who administer the treatments.

详细描述

Primary objective :

  • Estimate the rupture of galenic prevalence of at least one molecule in a population of subjects aged 65 years or over living at home and taking at least one oral drug for 2 weeks or more.

Secondary objectives:

  • Identify the drug classes most frequently involved in the rupture of galenic in a population of subjects aged 65 years of age or over at home;
  • Identify the actors of the drug administration in a population of subjects aged 65 years of or over at home;
  • To determine the medical and sociodemographic factors associated with the rupture of galenic in a population of subjects aged 65 years or over at home;
  • To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 65 or over;
  • Patient taking at least one oral medication for two weeks or more;
  • Patient affiliated to a social security scheme;
  • Patient who has agreed to reply to the questionnaire or, in case of inability to agree, agreement obtained from the caregiver or guardian/curator.

排除标准

  • Patient unable to answer questionnaires and without a referent caregiver capable of reply ;
  • Patient having changed residence for two weeks or less;
  • Patient residing in a residential care facility for dependent elderly people.

结局指标

主要结局

Estimate the rupture of galenic prevalence of at least one molecule in a population of subjects aged 65 years or over living at home and taking at least one oral drug for 2 weeks or more.

时间窗: 12 months

Calculation of the prevalence of galenic rupture by dividing the number of persons with at least one rupture of galenic by the number of persons included in the study.

次要结局

  • To determine the drug classes most frequently involved in the rupture of galenic in a population of subjects aged 65 years of age or over at home(12 months)
  • To determine the modalities of rupture of galenic in a population of subjects aged 65 or over at home(12 months)
  • To determine the actors of the drug administration in a population of subjects aged 65 years of or over at home(12 months)
  • To determine the medical and sociodemographic factors associated with the rupture of galenic in a population of subjects aged 65 years or over at home(12 months)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

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