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Mobile Health Strategies for Veterans

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message
Mobile Application
Website
Sponsored by
San Francisco Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Heart Disease focused on measuring mobile health, veterans, cardiovascular disease, medication adherence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Muir Medical CenterRecruiting
  • VA Palo Alto Health Care SystemRecruiting
  • San Francisco Veterans Affairs Medical CenterRecruiting
  • North Florida/South Georgia Veterans Health SystemRecruiting
  • VA North Texas Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Text Message Group

Application Group

Website-Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in medication adherence over 12 months
Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns
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.
Change in medication adherence at 12 months
Medication recall questionnaire that will assess how many missed doses there were.
Change in medication adherence at 12 months
VA Corporate Data Warehouse refill data (Veteran participants)
Change in medication adherence at 12 months
Peoplechart Meds Incontext refill data (non-Veteran participants)

Secondary Outcome Measures

Full Information

First Posted
January 12, 2017
Last Updated
September 27, 2021
Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
John Muir Medical Center, North Florida/South Georgia Veterans Health System, North Texas Veterans Healthcare System, VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03022669
Brief Title
Mobile Health Strategies for Veterans
Official Title
Mobile Health Strategies for Veterans With Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
John Muir Medical Center, North Florida/South Georgia Veterans Health System, North Texas Veterans Healthcare System, VA Palo Alto Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
mobile health, veterans, cardiovascular disease, medication adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Text Message Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Application Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Website-Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Message
Intervention Description
Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)
Intervention Type
Behavioral
Intervention Name(s)
Mobile Application
Intervention Type
Other
Intervention Name(s)
Website
Intervention Description
American Heart Association patient education website
Primary Outcome Measure Information:
Title
Change in medication adherence over 12 months
Description
Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns
Time Frame
12 months
Title
Change in medication adherence over 12 months
Description
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.
Time Frame
12 months
Title
Change in medication adherence at 12 months
Description
Medication recall questionnaire that will assess how many missed doses there were.
Time Frame
12 months
Title
Change in medication adherence at 12 months
Description
VA Corporate Data Warehouse refill data (Veteran participants)
Time Frame
12 months
Title
Change in medication adherence at 12 months
Description
Peoplechart Meds Incontext refill data (non-Veteran participants)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Park, PhD, MS, FNP
Email
Linda.Park@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julia von Oppenfeld
Phone
415-676-1153
Email
Julia.vonOppenfeld@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Park, PhD
Organizational Affiliation
San Francisco Veterans Medical Center; University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia von Oppenfeld
Phone
415-676-1153
Email
Julia.vonOppenfeld@va.gov
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia von Oppenfeld
Phone
415-676-1153
Email
Julia.vonOppenfeld@va.gov
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia von Oppenfeld
Phone
415-676-1153
Email
Julia.vonOppenfeld@va.gov
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia von Oppenfeld
Phone
415-676-1153
Email
Julia.vonOppenfeld@va.gov
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia von Oppenfeld
Phone
415-676-1153
Email
Julia.vonOppenfeld@va.gov

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28720557
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.
Results Reference
derived

Learn more about this trial

Mobile Health Strategies for Veterans

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