App Reminder on ASA Adherence
2019年10月21日 更新者：Deborah Wittig-Wells, RN, PhD、Emory University
Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy
The purpose of this study is to explore the impact of using a smartphone app reminder on medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as anti-thrombotic therapy after knee or hip arthroplasty.
This study will randomly assign participants to get usual postoperative care which is teaching with verbal instructions and printed information about taking the aspirin at the time of discharge, or to have an app on your smartphone with preset reminders in addition to usual postoperative discharge teaching after surgery.
研究概览
详细说明
The purpose of this study is to evaluate the impact of using a smartphone application (app) reminder on medication adherence twice daily in 200 adults prescribed 81 milligrams of aspirin (ASA) for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. The aim is to determine if an app downloaded on a smartphone that reminds patients twice a day to take their ASA as prescribed will improve ASA adherence and clinical outcomes for patients after total knee and total hip joint arthroplasty compared to those in the usual care.
This is a two group, randomized control study with random assignment into the control group for usual care or the intervention group to receive a medication reminder app for their smart phone (daily for 35 days) plus usual care. Participants will receive a baseline interview for demographic and other data and 36 day follow-up assessment, both conducted in person.
研究类型
介入性
注册 (实际的)
195
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Georgia
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Atlanta、Georgia、美国、30084
- Emory Orthopedic and Spine Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Prescribed aspirin 81 mg twice a day for 35 days
- Ability to write and speak English
- Have a smart phone with the capacity to download and set an app
- Own and use a smart phone for communication purposes
Exclusion Criteria:
- Diagnosis of mental illness
- Do not own a smart phone
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Standard Education
Participants randomized to this arm will receive the standard education provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery.
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Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.
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实验性的：Medication Reminder App + Standard Education
Participants randomized to this arm will use a smartphone app with preset reminders to take aspirin to prevent thromboembolic events after orthopedic surgery in addition to usual postoperative discharge teaching.
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Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.
Participants will use a medication reminder app that is set in collaboration with the participants for times that fit into their daily lifestyle.
The app will alert participants when it is time (selected by the participant) to take their medication.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Pills Taken
大体时间：Post- Operative Visit (Day 36)
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The proportion of pills taken is defined as the percentage of pills taken by study participants.
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Post- Operative Visit (Day 36)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
大体时间：Post- Operative Visit (Day 36)
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The ACTG Adherence Questionnaire consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication.
Each item is rated from 0 ("I cannot do at all") to 10 ("Sure I can do"), with total scores found by summing responses to individual items and dividing by 19.
Higher scores correspond to higher levels of medication self-efficacy.
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Post- Operative Visit (Day 36)
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Aspirin (ASA) Self-Efficacy Scale Score
大体时间：Post- Operative Visit (Day 36)
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The ASA Self-Efficacy Scale consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication.
Each item is rated from 0 ("I cannot do at all") to 10 ("Sure I can do"), with total scores found by summing responses to individual items and dividing by 19.
Higher scores correspond to higher levels of medication self-efficacy.
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Post- Operative Visit (Day 36)
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Number of Thromboembolic Events
大体时间：Post- Operative Visit (Day 36)
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Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.
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Post- Operative Visit (Day 36)
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Aspirin (ASA) General Adherence Scale Score
大体时间：Post- Operative Visit (Day 36)
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The ASA General Adherence Scale measures the ease and ability to adhere to the ASA regimen as prescribed.
It is scored by summing responses to the individual items and creating a total score.
Higher scores indicate better self-reported adherence.
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Post- Operative Visit (Day 36)
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Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score
大体时间：Baseline (Pre-Intervention)
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The UTAUT2 measures antecedents (performance expectancy, effort expectancy, hedonic motivation) and behavioral intent to use mobile apps.
Items are scored using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree).
Survey totals range between 14 and 112.
Higher scores are indicative of greater acceptance and intent to adopt the target technology.
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Baseline (Pre-Intervention)
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Performance Expectancy Subscale Score
大体时间：Baseline (Pre-Intervention)
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The Performance Expectancy Subscale measures the perceived benefits of mobile app technology to the consumer.
Scores range from 4 to 28, with higher totals indicating better perceptions of technology-related benefits.
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Baseline (Pre-Intervention)
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Effort Expectancy Subscale Score
大体时间：Baseline (Pre-Intervention)
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The Effort Expectancy Subscale measures the ease with which the consumer can learn and operate an app.
Scores range from 4 to 28, with higher totals indicating greater beliefs that the technology is easy and accessible.
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Baseline (Pre-Intervention)
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Hedonic Motivation Subscale Score
大体时间：Baseline (Pre-Intervention)
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The Hedonic Motivation subscale measures the enjoyment, the consumer experiences from using an app.
Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue).
Scoring is kept continuous with higher scores indicating greater enjoyment.
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Baseline (Pre-Intervention)
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Behavioral Intent Subscale Score
大体时间：Baseline (Pre-Intervention)
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The Behavioral Intent Subscale measures the decision to use a mobile app.
Scores range from 3 to 21, with higher totals indicating a greater intent to use or adopt an app.
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Baseline (Pre-Intervention)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Deborah Wittig-Wells, PhD、Emory University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月3日
初级完成 (实际的)
2019年3月8日
研究完成 (实际的)
2019年3月8日
研究注册日期
首次提交
2017年8月7日
首先提交符合 QC 标准的
2017年8月7日
首次发布 (实际的)
2017年8月9日
研究记录更新
最后更新发布 (实际的)
2019年10月23日
上次提交的符合 QC 标准的更新
2019年10月21日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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