Mobile Health Strategies for Veterans

Coronary Heart Disease Clinical Trial

Official title:

Mobile Health Strategies for Veterans With Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03022669
• Other study ID #: NRI 15-455
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: San Francisco Veterans Affairs Medical Center
• Contact: Linda Park, PhD, MS, FNP
• Email: Linda.Park[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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)
• Mobile Application

Other:
• Website
American Heart Association patient education website

Locations

Country	Name	City	State
United States	John Muir Medical Center	Concord	California
United States	VA North Texas Health Care System	Dallas	Texas
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
San Francisco Veterans Affairs Medical Center	John Muir Medical Center, North Florida/South Georgia Veterans Health System, North Texas Veterans Healthcare System, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

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