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临床试验/NCT02071498
NCT02071498已完成不适用

Effectiveness and Utility of a Virtual Custom Tool to Reduce the Medication Errors of Patients Older Than 65 Years Pluripatologic With Complex Therapeutic Regimens

Universidad Miguel Hernandez de Elche1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2012年6月1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
99
试验地点
1
主要终点
adherence

研究概览

简要总结

Background: Non-adherence and medication errors are common among patients with complex drug regimens. Applications for smartphones and tablets are known to be effective for improving adherence but they have not been tested in elderly patients with such complex chronic conditions, their older age meaning they tend to have less experience with this type of technology.

Objective: to design, implement and evaluate a medication self-management application for elderly patients taking multiple medications called ALICE with the intention of improving adherence and safe medication use.

Methods: A single-blind randomized controlled trial was conducted with a control and an experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7 professionals. ALICE was designed for Android and iOS and to allow the personalisation of prescriptions and medical advice, showing images of each of the medications (the packaging and the medication itself) together with alerts and multiple reminders for each alert. The randomly subjects in the control group received oral and written information on the safe use of their medications and the experimental group used ALICE for three months. Pre- and post- measures included: rate of missed doses and medication errors reported by patients, Morisky Medication Adherence 4 items Scale scores, level of independence, self-perceived health status and biochemical test results of the patients. In the experimental group, data were also collected on their previous experience with information and communication technologies, their rating of ALICE and their perception of the level of independence they had achieved. The inter-group intervention effects were calculated by univariate linear models and ANOVA, with the pre- to post-intervention differences as the dependent variables.

详细描述

A tablet-based medication self-management app (called ALICE) was designed to help patients to remember to take all their medications, at the correct doses, distinguish between drugs to avoid confusions, avoid known potential interactions and common errors in use of the medications and know how to properly store the medications. The app design was based on suggestions extracted from 3 nominal groups with a total of 23 patients and a focus group with 7 professionals (3 physicians and 4 pharmacists).

The tablet used was selected on the basis of the need for a device with an at least 7-inch, easy to use touch screen, ensuring that users would only have to follow simple instructions and tap on some icons on the screen. Specifically, the BQ Verne Plus 3G with an LCD Tactile screen was chosen in the case of Android, and an iPad 2 with Wi-Fi + 3G in the case of the iOS.

This study has been approved and financed by the Spanish Ministry of Health, Equality, and Social Policy. The Spanish Research Health Agency (FIS), Independent Clinical Research, project number EC11-527. The Experimental Research Ethics Committee of Miguel Hernández University (DPS-JJM-003-11) approved the trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Multimorbid patients taking multiple medications
  • •Over 65 years old, with a Barthel score of more than 60
  • •Living in their own home
  • •Able to manage the administration of their medication at home

排除标准

  • •Refusing to participate in the study
  • •More than 90 years old

研究组 & 干预措施

Pillbox app named ALICE

Experimental

pillbox app for elderly patients taking multiple medications. App was used during three months

干预措施: Pillbox app named ALICE (Device)

oral and written information

Active Comparator

oral and written information regarding the main risks related to their medications and the most common errors of patients

干预措施: oral and written information (Other)

结局指标

主要结局

adherence

时间窗: participants will be followed using ALICE, an expected average of 3 months

All the participating patients completed a questionnaire (The Morisky Medication Adherence 4 items Scale) to assess the rates of missed doses Number of alerts of the pillbox app that were not dealt

次要结局

  • safety medication use(participants will be followed using ALICE, an expected average of 3 months)

研究者

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

José Joaquín Mira

Principal researcher

Universidad Miguel Hernandez de Elche

研究点 (1)

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