Mobile Health Strategies for Veterans

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Mobile Health Strategies for Veterans With Coronary Heart Disease

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Text Message
* Behavioral: Mobile Application
* Other: Website


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 21 years of age, recent ACS or PCI within 1 week new antiplatelet (thienopyridine) prescription owns a smartphone Exclusion Criteria: cognitive impairment lack of English proficiency/literacy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text Message Group<br>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. | Behavioral: Text Message<br>* Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)<br>Other: Website<br>* American Heart Association patient education website<br>|
| Experimental: Application Group<br>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. | Behavioral: Mobile Application<br> <br> Other: Website<br>* American Heart Association patient education website<br>|
| Experimental: Website-Control<br>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. | Other: Website<br>* American Heart Association patient education website<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication adherence over 12 months | Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns | 12 months | 
| Change in medication adherence over 12 months | Adherence to Refills and Medications Scale (ARMS)- There are two subscale scores for medication taking and medication refills. The total score is found by adding both subscales. Scores can range from 12 to 48 with 12 being completely medication adherent and 48 being completely non-adherent. | 12 months | 
| Change in medication adherence at 12 months | Medication recall questionnaire that will assess how many missed doses there were. | 12 months | 
| Change in medication adherence at 12 months | VA Corporate Data Warehouse refill data (Veteran participants) | 12 months | 
| Change in medication adherence at 12 months | Peoplechart Meds Incontext refill data (non-Veteran participants) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, veterans, cardiovascular disease, medication adherence