Clinical trial NCT03022669: Mobile Health Strategies for Veterans
Official title: Mobile Health Strategies for Veterans With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: mobile health
veterans
cardiovascular disease
medication adherence
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: John Muir Medical Center
name: North Florida/South Georgia Veterans Health System
name: North Texas Veterans Healthcare System
name: VA Palo Alto Health Care System
First posted: 2017-01-16
Enrollment: 225
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in medication adherence over 12 months
timeFrame: 12 months
measure: Change in medication adherence over 12 months
timeFrame: 12 months
measure: Change in medication adherence at 12 months
timeFrame: 12 months
measure: Change in medication adherence at 12 months
timeFrame: 12 months
measure: Change in medication adherence at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: San Francisco Veterans Medical Center; University of California, San Francisco
name: Linda Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.