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临床试验/NCT03022669
NCT03022669Unknown不适用

Mobile Health Strategies for Veterans With Coronary Heart Disease

San Francisco Veterans Affairs Medical Center5 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
225
试验地点
5
主要终点
Change in medication adherence over 12 months

研究概览

简要总结

The purpose of this study is to determine whether text messages/messaging (TM) or a mobile application (app), compared with an educational website-control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome or percutaneous coronary intervention (ACS/PCI).

详细描述

Adherence to antiplatelet medications is critical to prevent life threatening complications (i.e., stent thrombosis); yet rates of non-adherence range from 21-57% by 12 months. Mobile technology through TM or mobile apps is a practical and inexpensive strategy to promote behavior change and enhance medication adherence. The three specific aims of this proposal are to: 1) determine preferences for content and frequency of TM to promote medication adherence through focus groups; 2) determine the most patient-centered app to promote adherence through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and 3) compare adherence to antiplatelet medications in 225 Veterans post ACS/PCI through a randomized controlled trial. Participants will be randomized to either TM, mobile app, or website-control group. The focus groups will be stratified by low/high mobile phone use and sex.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥ 21 years of age,
  • •recent ACS or PCI within 1 week
  • •new antiplatelet (thienopyridine) prescription
  • •owns a smartphone

排除标准

  • •cognitive impairment
  • •lack of English proficiency/literacy

研究组 & 干预措施

Text Message Group

Experimental

The "TM group" will use the VA "Annie" text messaging program to remind patients to take antiplatelet medications. The content for the text messages will be determined through preliminary focus groups that will be conducted prior to the RCT.

干预措施: Text Message (Behavioral)

Text Message Group

Experimental

The "TM group" will use the VA "Annie" text messaging program to remind patients to take antiplatelet medications. The content for the text messages will be determined through preliminary focus groups that will be conducted prior to the RCT.

干预措施: Website (Other)

Application Group

Experimental

The "App group" will use a mobile application to remind patients to take antiplatelet medications. The commercially available mobile app will be selected by participants through preliminary focus groups that will be conducted prior to the RCT.

干预措施: Mobile Application (Behavioral)

Application Group

Experimental

The "App group" will use a mobile application to remind patients to take antiplatelet medications. The commercially available mobile app will be selected by participants through preliminary focus groups that will be conducted prior to the RCT.

干预措施: Website (Other)

Website-Control

Experimental

The "Website-Control group" will will be offered the American Heart Association patient education website (My Life Check - 7 Steps To Healthy Living) and will serve as an "attention-control." The website will be offered to participants in all three groups. The "7 small steps to big changes" are to manage blood pressure, control cholesterol, reduce blood sugar, get active, eat better, lose weight, and stop smoking.

干预措施: Website (Other)

结局指标

主要结局

Change in medication adherence over 12 months

时间窗: 12 months

Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns

Change in medication adherence at 12 months

时间窗: 12 months

Medication recall questionnaire that will assess how many missed doses there were.

次要结局

未报告次要终点

研究者

发起方
San Francisco Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Linda Park

Assistant Professor

University of California, San Francisco

研究点 (5)

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