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临床试验/NCT05098743
NCT05098743已完成不适用

The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年11月19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
65
试验地点
2
主要终点
Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)

研究概览

简要总结

Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.

详细描述

Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.

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
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
否

入选标准

  • •adults aged 18 years and older
  • •speak and understand English
  • •personally own and use an Android or Apple smartphone and
  • •take at least 1 medication for a chronic illness based on their computerized medical record at the health center.

排除标准

  • •already using a medication reminder app or other electronic reminder system such as phone alarms
  • •own smartphones that are not capable of downloading the app
  • •patients with severe dementia or serious mental illness, and
  • •inability to use a mobile phone or the medication reminder software either physically or cognitively.

研究组 & 干预措施

Participants using the medication adherence mobile application.

Experimental

Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.

干预措施: Medisafe smartphone mobile application (Behavioral)

Participants using a printed copy of their medication list.

Active Comparator

Participants in this arm will use a printed out copy of their medication list for thirty days.

干预措施: Printed medication list (Behavioral)

结局指标

主要结局

Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)

时间窗: Baseline to 30 days.

The SEAMS is a global (continuous) 13-item scale, responses range from 1 (not confident) to 3 (very confident), with a possible score of 13-39. Patients with higher scores indicate higher levels of self-efficacy for medication adherence. It is valid and reliable in low-literacy chronic disease populations. Patients are asked their level of confidence about taking medications correctly.

Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS)

时间窗: Baseline to 30 days.

The ARMS is a global (continuous) 12-item scale, responses range from 1 (none) to 4 (all of the time) with a possible score of 12-48, patients with low ARMS scores indicate better adherence, it is valid and reliable in a low-literacy chronic disease population.

次要结局

未报告次要终点

研究者

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

Christa Hartch

Principal Investigator

Vanderbilt University

研究点 (2)

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