Mobile Health Strategies for Veterans
1 other identifier
interventional
225
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedSeptember 29, 2021
September 1, 2021
5.8 years
January 12, 2017
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (3)
Text Message Group
EXPERIMENTALThe "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.
Application Group
EXPERIMENTALThe "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.
Website-Control
EXPERIMENTALThe "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
Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)
American Heart Association patient education website
Eligibility Criteria
You may qualify if:
- ≥ 21 years of age,
- recent ACS or PCI within 1 week
- new antiplatelet (thienopyridine) prescription
- owns a smartphone
You may not qualify if:
- cognitive impairment
- lack of English proficiency/literacy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- San Francisco Veterans Affairs Medical Centerlead
- John Muir Medical Centercollaborator
- North Florida/South Georgia Veterans Health Systemcollaborator
- North Texas Veterans Healthcare Systemcollaborator
- VA Palo Alto Health Care Systemcollaborator
Study Sites (5)
John Muir Medical Center
Concord, California, 94520, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
Related Publications (1)
Park LG, Collins EG, Shim JK, Whooley MA. Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study. JMIR Res Protoc. 2017 Jul 18;6(7):e134. doi: 10.2196/resprot.7327.
PMID: 28720557DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Park, PhD
San Francisco Veterans Medical Center; University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 12, 2017
First Posted
January 16, 2017
Study Start
December 1, 2016
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
September 29, 2021
Record last verified: 2021-09