Mobile Health Strategies for Veterans

September 27, 2021 updated by: Linda Park, San Francisco Veterans Affairs Medical Center

Mobile Health Strategies for Veterans With Coronary Heart Disease

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Concord, California, United States, 94520
        • Recruiting
        • John Muir Medical Center
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto Health Care System
        • Contact:
      • San Francisco, California, United States, 94121
        • Recruiting
        • San Francisco Veterans Affairs Medical Center
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • North Florida/South Georgia Veterans Health System
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216
        • Recruiting
        • VA North Texas Health Care System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Change in medication adherence over 12 months
Time Frame: 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
Time Frame: 12 months
Medication recall questionnaire that will assess how many missed doses there were.
12 months
Change in medication adherence at 12 months
Time Frame: 12 months
VA Corporate Data Warehouse refill data (Veteran participants)
12 months
Change in medication adherence at 12 months
Time Frame: 12 months
Peoplechart Meds Incontext refill data (non-Veteran participants)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

VA Palo Alto Health Care System
North Texas Veterans Healthcare System
North Florida/South Georgia Veterans Health System
John Muir Medical Center

Investigators

  • Principal Investigator: Linda Park, PhD, San Francisco Veterans Medical Center; University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRI 15-455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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