Coronary Heart DiseaseNCT03022669
Mobile Health Strategies for Veterans
A study testing Text Message, Mobile Application and Website in people with Coronary Heart Disease, run by San Francisco Veterans Affairs Medical Center at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Text Message, Mobile Application and Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2016to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 21 years of age,
- recent ACS or PCI within 1 week
- new antiplatelet (thienopyridine) prescription
- owns a smartphone
Who cannot join
- cognitive impairment
- lack of English proficiency/literacy
Trial locations and contacts
5 sites in 1 country.
Linda Park, PhD, MS, FNP contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
John Muir Medical Center
Concord, California, 94520
Julia von Oppenfeld, 415-676-1153, Julia.vonOppenfeld@va.gov
- Recruiting
VA North Texas Health Care System
Dallas, Texas, 75216
Julia von Oppenfeld, 415-676-1153, Julia.vonOppenfeld@va.gov
- Recruiting
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
Julia von Oppenfeld, 415-676-1153, Julia.vonOppenfeld@va.gov
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Julia von Oppenfeld, 415-676-1153, Julia.vonOppenfeld@va.gov
- Recruiting
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
Julia von Oppenfeld, 415-676-1153, Julia.vonOppenfeld@va.gov
About this study
Official title: Mobile Health Strategies for Veterans With Coronary Heart Disease
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).
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Text Message, Mobile Application, Website
- Keywords
- mobile health, veterans, cardiovascular disease, medication adherence
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageBehavioural
Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)
Mobile ApplicationBehavioural
WebsiteOther
American Heart Association patient education website
| Study group | Role | What they receive |
|---|---|---|
| Text Message Group | Experimental | 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. Receives: Behavioral: Text Message; Other: Website |
| Application Group | Experimental | 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. Receives: Behavioral: Mobile Application; Other: Website |
| Website-Control | Experimental | 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. Receives: Other: Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence over 12 months
Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns
Measured: 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.
Measured: 12 months
Change in medication adherence at 12 months
Medication recall questionnaire that will assess how many missed doses there were.
Measured: 12 months
Change in medication adherence at 12 months
VA Corporate Data Warehouse refill data (Veteran participants)
Measured: 12 months
Change in medication adherence at 12 months
Peoplechart Meds Incontext refill data (non-Veteran participants)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- John Muir Medical Center, North Florida/South Georgia Veterans Health System, North Texas Veterans Healthcare System, VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Linda Park, University of California, San Francisco
- Investigators
- Linda Park, PhD, Principal investigator, San Francisco Veterans Medical Center; University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022669
- Sponsor's protocol ID
- NRI 15-455
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28720557
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Strategies for Veterans With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03022669
- Acronym / sponsor ID
- NRI 15-455
- Conditions
- Coronary Heart Disease
- Keywords
- mobile health, veterans, cardiovascular disease, medication adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- John Muir Medical Center, North Florida/South Georgia Veterans Health System, North Texas Veterans Healthcare System, VA Palo Alto Health Care System
- Study start
- Dec 2016
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Text Message Group | Experimental | Behavioral: Text Message, Other: WebsiteThe "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 | Experimental | Behavioral: Mobile Application, Other: WebsiteThe "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 | Experimental | Other: WebsiteThe "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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 21 years of age,
- recent ACS or PCI within 1 week
- new antiplatelet (thienopyridine) prescription
- owns a smartphone
Key exclusion criteria (2 listed)
- cognitive impairment
- lack of English proficiency/literacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessageAnnie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility) | Behavioural | Text Message Group |
| Mobile Application | Behavioural | Application Group |
| WebsiteAmerican Heart Association patient education website | Other | Application Group, Text Message Group, Website-Control |
Primary outcome
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
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.
Change in medication adherence at 12 months
Time frame: 12 months
Medication recall questionnaire that will assess how many missed doses there were.
Change in medication adherence at 12 months
Time frame: 12 months
VA Corporate Data Warehouse refill data (Veteran participants)
Change in medication adherence at 12 months
Time frame: 12 months
Peoplechart Meds Incontext refill data (non-Veteran participants)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 28720557Park 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Park, PhD, MS, FNP contact
Linda Park, PhD principal investigator
San Francisco Veterans Medical Center; University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message, Mobile Application and Website in people with Coronary Heart Disease, run by San Francisco Veterans Affairs Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Park, PhD, MS, FNP (Linda.Park@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence over 12 months (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.