Recruiting

Observational Study

Sponsor:

San Francisco Veterans Affairs Medical Center

Code:

NCT03022669

Conditions

Coronary Heart Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Text Message

Mobile Application

Website

Study Details

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).

Conditions

Coronary Heart Disease

Study ID

NCT03022669

Start date

Dec, 2016

Status verified date

Sep, 2021

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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

Website

American Heart Association patient education website

Primary outcome measure

  • Change in medication adherence over 12 months [ Time Frame: 12 months ]
  • Change in medication adherence over 12 months [ Time Frame: 12 months ]
  • Change in medication adherence at 12 months [ Time Frame: 12 months ]
  • Change in medication adherence at 12 months [ Time Frame: 12 months ]
  • Change in medication adherence at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Linda Park, PhD, MS, FNP

Linda.Park@ucsf.edu

Julia von Oppenfeld

415-676-1153Julia.vonOppenfeld@va.gov

Locations

John Muir Medical Center

Recruiting

Concord, California, United States, 94520

Contacts

Julia von Oppenfeld

415-676-1153Julia.vonOppenfeld@va.gov

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Julia von Oppenfeld

415-676-1153Julia.vonOppenfeld@va.gov

San Francisco Veterans Affairs Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Julia von Oppenfeld

415-676-1153Julia.vonOppenfeld@va.gov

North Florida/South Georgia Veterans Health System

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Julia von Oppenfeld

415-676-1153Julia.vonOppenfeld@va.gov

VA North Texas Health Care System

Recruiting

Dallas, Texas, United States, 75216

Contacts

Julia von Oppenfeld

415-676-1153Julia.vonOppenfeld@va.gov

More Information

Sponsor

San Francisco Veterans Affairs Medical Center

Last update posted

Sep 29, 2021

Last verified

Sep, 2021

Keywords

  • mobile health
  • veterans
  • cardiovascular disease
  • medication adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by San Francisco Veterans Affairs Medical Center on 2021-09-29.