Mobile Health Strategies for Veterans

NCT ID: NCT03022669

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Text Message

Intervention Type BEHAVIORAL

Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)

Website

Intervention Type OTHER

American Heart Association patient education website

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.

Group Type EXPERIMENTAL

Mobile Application

Intervention Type BEHAVIORAL

Website

Intervention Type OTHER

American Heart Association patient education website

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.

Group Type EXPERIMENTAL

Website

Intervention Type OTHER

American Heart Association patient education website

Interventions

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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)

Intervention Type BEHAVIORAL

Mobile Application

Intervention Type BEHAVIORAL

Website

American Heart Association patient education website

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John Muir Medical Center

UNKNOWN

Sponsor Role collaborator

North Florida/South Georgia Veterans Health System

OTHER

Sponsor Role collaborator

North Texas Veterans Healthcare System

FED

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Linda Park

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Park, PhD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Veterans Medical Center; University of California, San Francisco

Locations

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John Muir Medical Center

Concord, California, United States

Site Status RECRUITING

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status RECRUITING

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Site Status RECRUITING

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Site Status RECRUITING

VA North Texas Health Care System

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Linda Park, PhD, MS, FNP

Role: CONTACT

Julia von Oppenfeld

Role: CONTACT

415-676-1153

Facility Contacts

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Julia von Oppenfeld

Role: primary

415-676-1153

Julia von Oppenfeld

Role: primary

415-676-1153

Julia von Oppenfeld

Role: primary

415-676-1153

Julia von Oppenfeld

Role: primary

415-676-1153

Julia von Oppenfeld

Role: primary

415-676-1153

References

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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.

Reference Type DERIVED
PMID: 28720557 (View on PubMed)

Other Identifiers

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NRI 15-455

Identifier Type: -

Identifier Source: org_study_id

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