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Clinical Trials/NCT03022669
NCT03022669UnknownNot Applicable

Mobile Health Strategies for Veterans With Coronary Heart Disease

San Francisco Veterans Affairs Medical Center10 sites in 1 country225 target enrollmentStarted: December 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
225
Locations
10
Primary Endpoint
Change in medication adherence over 12 months

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in medication adherence over 12 months

Time Frame: 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

Time Frame: 12 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
San Francisco Veterans Affairs Medical Center
Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Linda Park

Assistant Professor

University of California, San Francisco

Study Sites (10)

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