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临床试验/NCT05611008
NCT05611008已完成不适用

Seniors Empowered Via Big Data to Joint-manage Their Medication-related Risk of Falling in Primary Care

University of Amsterdam1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Shared decision making

研究概览

简要总结

Falls are a leading cause of injuries among older patients. Medication use is a major risk factor for falls. Because we lack tools to assess individualized risks, general practitioners (GPs) struggle with fall-related medication management for older patients. Furthermore, these older patients are often not properly equipped to engage in the joint management of their medication. A Clinical Decision Support System (CDSS) for GPs and a patient portal for older patients may stimulate shared decision making between GPs and older patients when discussing the medication-related fall risk. The CDSS provides the GP with advice on how to alter medication in such a way that the fall risk decreases, and the patient portal helps the older patient to prepare for a consultation and to engage in the joint management of their medication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • •Aged 70 years or older
  • •High fall risk
  • •Takes at least 1 Fall Risk Increasing Drug (FRID)

排除标准

  • 未提供

研究组 & 干预措施

Intervention condition

Experimental

干预措施: CDSS (Device)

Intervention condition

Experimental

干预措施: Patient Portal (Device)

Control condition

No Intervention

结局指标

主要结局

Shared decision making

时间窗: During consultation

This concerns the extent to which shared decision making between patient and GP during the consultation. This will be assessed using the Observer OPTION Multiple Chronic Conditions (OPTION-MCC). Consultation are audiotaped and will be coded on shared decision making using this coding scheme.

次要结局

  • Technology Acceptance Model (TAM; patient portal)(At baseline & two weeks after consultation)
  • Website Satisfaction Scale (WSS; patient portal)(At baseline & two weeks after consultation)
  • Patient portal usage(At baseline & two weeks after consultation)
  • Technology Acceptance Model (TAM; CDSS)(After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months))
  • Netherlands Patient Information Recall Questionnaire (NPIRQ)(Two weeks after consultation)
  • Decisional Conflict Scale (DCS)(Two weeks after consultation)
  • Beliefs About Medicines Questionnaire (BMQ)(Baseline & two weeks after consultation)
  • Changes in medication(Baseline & two weeks after the consultation)
  • Evaluation of the consultation(Immediately after each consultation)
  • The Website Satisfaction Scale (WSS; CDSS)(After the first consultation (study beginning) and after the last consultation (study completion after +/- 7 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia van Weert

Prof. dr. Julia van Weert

University of Amsterdam

研究点 (1)

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