Mobile Application for Heart Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Palo Alto Health Care System, Palo Alto, CA
Heart Diseases+4 More
Mobile Application - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a mobile app or text messages can improve adherence to antiplatelet therapy.

See full description

Eligible Conditions

  • Heart Diseases
  • Coronary Heart Disease (CHD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Mobile Application will improve 2 primary outcomes in patients with Heart Diseases. Measurement will happen over the course of 12 months.

12 months
Change in medication adherence at 12 months
Change in medication adherence over 12 months

Trial Safety

Trial Design

3 Treatment Groups

Website-Control
1 of 3
Text Message Group
1 of 3
Application Group
1 of 3
Experimental Treatment

This trial requires 225 total participants across 3 different treatment groups

This trial involves 3 different treatments. Mobile Application is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Website-Control
Other
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.
Text Message GroupThe "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 GroupThe "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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Text Message
2011
Completed Phase 1
~35920
Mobile Application
2018
N/A
~250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
L. P.
Prof. Linda Park, Assistant Professor
University of California, San Francisco

Closest Location

VA Palo Alto Health Care System - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
≥ 21 years of age
recent ACS or PCI within 1 week
new antiplatelet (thienopyridine) prescription
owns a smartphone

Patient Q&A Section

What is coronary artery disease?

"Symptoms of myocardial infarction (heart attack) occur most commonly with acute onset of pain in the chest or arm, and when there is no specific pain, the patient may have a heart attack on the basis of symptoms. The diagnosis of MI is made by examining the electrocardiogram and obtaining angiograms and echocardiograms. Early AMI is uncommon. Infarction and angina are not specific to CAD in that a wide variety of other disease processes cause these symptoms. Thus, angiography remains the gold standard of diagnosis and follow-up." - Anonymous Online Contributor

Unverified Answer

What are the signs of coronary artery disease?

"The first sign of CAD is often experienced by high-risk patients, such as those with hypertension and metabolic syndrome. Those diagnosed with CAD may have symptoms of angina, and the severity of symptoms may be worse for women or people who are overweight, smokers, or have diabetes." - Anonymous Online Contributor

Unverified Answer

How many people get coronary artery disease a year in the United States?

"In the United States, almost 6 million people have coronary artery disease. This is the most common form of heart disease, and by age 75, 9.7 million American adults have diagnosed coronary artery disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for coronary artery disease?

"Cardiac revascularization involving the coronary artery arteries includes percutaneous coronary intervention, coronary bypass surgery, or direct stenting of the arteries. In addition, therapies for high blood cholesterol help to manage the risk of cardiovascular disease in people with known coronary artery disease. Finally, aspirin and anticoagulants help to prevent and treat heart attacks." - Anonymous Online Contributor

Unverified Answer

Can coronary artery disease be cured?

"Coronary artery disease can be asymptomatic and nonlethal at diagnosis. The current literature does not provide strong evidence that there is a cure for the disease." - Anonymous Online Contributor

Unverified Answer

What causes coronary artery disease?

"The leading cause of cardiovascular deaths is coronary artery disease. The incidence of the disease has been steadily increasing in postmenopausal women and in women 65 and older." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mobile application?

"A well designed mobile application will improve the efficiency and effectiveness of cardiac rehabilitation. Because of the large number of mobile application developers, the design of an application should be considered not only for the improvement of the effectiveness of application but also with ease of operation in the clinical practice of mobile application." - Anonymous Online Contributor

Unverified Answer

What is mobile application?

"The mobile app had high success rates to teach high-risk CAD patients to follow the risk stratification steps for secondary prevention with statins and aspirin." - Anonymous Online Contributor

Unverified Answer

How serious can coronary artery disease be?

"Considering the current state of the scientific evidence, the extent of the coronary artery disease is not serious, but the severity of the disease and the likelihood of developing life-threatening events are very significant. The severity and nature of the disease is not so much dependent on who you are or where you live, but on how good your health, including the way you are currently eating and drinking, are. And the risks are not simply due to the fact that the disease will eventually kill you." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of coronary artery disease?

"In addition to the conventional risk factors of [smoking and dyslipidemia], and the presence of [a family history of coronary bypass graft disease] have been established. Thus, an altered biological environment, such as the presence of [hypertension], [hyperglycemia], and [hyperuricemia], is at least sufficient to cause the abnormal vessel walls and, thus, the formation of [coronary artery disease]. These changes result from [metabolic disorders], [gendernational predisposition], and [stress]." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating coronary artery disease?

"There have been no new advancements in treating CAD. Many of our treatments used have a known benefit in some patients, but the benefit is not significant enough to be useful in preventing mortality or morbidity. There have been no clinical trials evaluating treatments for CAD. If they do exist then we have not seen any evidence that they have led to a new paradigm for treatment. The best that can be said is that we know how to treat CAD and don’t need to tinker with what we know. It would be better to focus on other aspects of cardio-vascular disease and the prevention of vascular disease rather than treatments for CAD." - Anonymous Online Contributor

Unverified Answer

What does mobile application usually treat?

"Digital imaging-based self-monitoring of health may lead to increased treatment of established cardiovascular risk factors. Moreover, the mobile application is effective in managing blood pressure and cholesterol by offering personalized individualised treatment plans." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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