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Mobile Health Strategies for Veterans

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ClinicalTrials.gov Identifier: NCT03022669
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
John Muir Medical Center
North Florida/South Georgia Veterans Health System
North Texas Veterans Healthcare System
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Linda Park, University of California, San Francisco

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Behavioral: Text Message Behavioral: Mobile Application Other: Website Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mobile Health Strategies for Veterans With Coronary Heart Disease
Study Start Date : December 2016
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. Change in medication adherence at 12 months [ Time Frame: 12 months ]
    Medication recall questionnaire that will assess how many missed doses there were.

  4. Change in medication adherence at 12 months [ Time Frame: 12 months ]
    VA Corporate Data Warehouse refill data (Veteran participants)

  5. Change in medication adherence at 12 months [ Time Frame: 12 months ]
    Peoplechart Meds Incontext refill data (non-Veteran participants)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022669


Contacts
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Contact: Linda Park, PhD, MS, FNP Linda.Park@ucsf.edu
Contact: Julia von Oppenfeld 415-676-1153 Julia.vonOppenfeld@va.gov

Locations
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United States, California
John Muir Medical Center Recruiting
Concord, California, United States, 94520
Contact: Julia von Oppenfeld    415-676-1153    Julia.vonOppenfeld@va.gov   
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Julia von Oppenfeld    415-676-1153    Julia.vonOppenfeld@va.gov   
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Julia von Oppenfeld    415-676-1153    Julia.vonOppenfeld@va.gov   
United States, Florida
North Florida/South Georgia Veterans Health System Recruiting
Gainesville, Florida, United States, 32608
Contact: Julia von Oppenfeld    415-676-1153    Julia.vonOppenfeld@va.gov   
United States, Texas
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Contact: Julia von Oppenfeld    415-676-1153    Julia.vonOppenfeld@va.gov   
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Linda Park, PhD San Francisco Veterans Medical Center; University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Linda Park, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03022669    
Other Study ID Numbers: NRI 15-455
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Park, University of California, San Francisco:
mobile health
veterans
cardiovascular disease
medication adherence
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases