CLINICAL TRIAL

Gaming in a virtual environment for Cardiovascular Diseases

Waitlist Available · 18+ · Male · Orange, CT

The LEARN Study for CVD Prevention

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About the trial for Cardiovascular Diseases

Treatment Groups

This trial involves 2 different treatments. Gaming In A Virtual Environment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Gaming in a virtual environment
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for male patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are gay, same-gender-loving, or men who have sex with men. show original
You are able to read and understand English. show original
You have access to a computer capable of downloading and running the VE software. show original
identify as an ethnic/racial minority living with HIV
no medical history of serious cardiovascular or cognitive complications
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline and Month 3 & 6
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline and Month 3 & 6.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Gaming in a virtual environment will improve 1 primary outcome and 4 secondary outcomes in patients with Cardiovascular Diseases. Measurement will happen over the course of Baseline and Month 3 & 6.

Acceptability/Feasibility {change over 3 timepoints}
BASELINE AND MONTH 3 & 6
Based on Technology Acceptance Model, using the same unit of measure, we will examine Perceived Usefulness (Cronbach's alpha 0.98) and Perceived Ease of Use (Cronbach's alpha 0.94) with an online 7-point Likert scale.
Tobacco and E-cigarette use {change over 3 timepoints}
BASELINE AND MONTH 3 & 6
BRFSS - self report measure questions that pertain to Tobacco use and E-cigarette use (7 questions). kappa statistic 0.81-0.92.
Physical Activity {change over 3 timepoints}
BASELINE AND MONTH 3 & 6
International Physical Activity Questionnaire - Short Form will assess intensity of physical activity and sitting time using a 7-item, open-ended measure. Cronbach's alpha 0.80.
Food consumption {change over 3 timepoints}
BASELINE AND MONTH 3 & 6
Food Frequency Questionnaire - Reports how frequently individuals consume foods in 16 categories. Multifactor Screener has demonstrated correlations of 0.5-0.8 with estimated true intake.
Cardiovascular health {change over 3 timepoints}
BASELINE AND MONTH 3 & 6
Life's Simple 7, based on 4 modifiable health behaviors, provides scores (range, 0 to 14) based on smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and fasting glucose.

Patient Q & A Section

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

What are common treatments for cardiovascular diseases?

The first common treatments for cardiovascular diseases are: non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin for headaches/abdominal pain and treatment of cardiovascular disease; diuretics such as furosemide and hydralazine for edema and hypertension; and ACEi such as lisinopril for hypertension.

Anonymous Patient Answer

What is cardiovascular diseases?

Chronic [Dysmetabolic disorders] are [chronic disorders] that are [associated with] chronic illness. In the following sections, it will be explained [what is cardiovascular diseases] in a little more detail on how these disorders affect [cardial function] and the impact on people.\n

Anonymous Patient Answer

How many people get cardiovascular diseases a year in the United States?

It is estimated that 10.6 million people in the United States have a cardiovascular disease every year, which corresponds to about 13.5% of adult population.

Anonymous Patient Answer

Can cardiovascular diseases be cured?

There is still much work to be done in the field of the prevention and treatment of hypertension and stroke. However, despite these obstacles many patients can now afford themselves an effective health-care.

Anonymous Patient Answer

What causes cardiovascular diseases?

Although cardiovascular conditions are among the most prevalent and important causes of mortality and morbidity in [Europe] (see 'Causes of diseases and disorders', above), their pathogenesis is largely unknown and many factors are involved. A better understanding of their physiopathological mechanisms would [make a] significant contribution to the comprehension of clinical pathogeny and of personalized medicine in cardiology, as well as [make] a significant contribution to the discovery of new therapeutic strategies.

Anonymous Patient Answer

What are the signs of cardiovascular diseases?

The common signs of cardiovascular disease do not apply to both type 1 and type 2 diabetes. Instead, a combination of low HDL cholesterol and elevated triglycerides increases the risk of cardiovascular disease and coronary heart disease in those with type 2 diabetes.

Anonymous Patient Answer

What are the common side effects of gaming in a virtual environment?

Gaming may lead to a number of positive and negative aspects. These are a concern for both the patient and those treating them. The present study provides an assessment of the prevalence of these aspects and highlights key points that we would like to raise with gaming clinics and gamblers. We recommend assessing the gaming addict at all gambling sessions, and informing patients and caregivers about the risks and benefits of gaming. Gaming clinics can consider using the [BETS] guideline.

Anonymous Patient Answer

How does gaming in a virtual environment work?

In a recent study, findings has indicated that video game-playing may be a reasonable alternative to conventional methods of post-cardiac-event rehabilitation, and it may also alleviate symptoms associated with post-cardiac rehabilitation recovery. More researches and a wider scope of application of videogames in post-cardiac-event rehabilitation are required.

Anonymous Patient Answer

Have there been other clinical trials involving gaming in a virtual environment?

To our knowledge, this is the first study to show the efficacy and the safety of computer-gambling in cardiovascular patients. Results from a recent clinical trial reported suggest a new use of the virtual reality system which may be a useful therapy not only for people living with diseases like stroke, diabetes, and hypertension, but also for those with mood disorders. Although further studies are needed to prove the applicability of this method, this work presents a novel and promising treatment method for the treatment of cardiovascular diseases. The game can be used as a form of rehabilitation and therapy for patients and patients' family.

Anonymous Patient Answer

What is the average age someone gets cardiovascular diseases?

The average age people receive CVD risk factors treatment is 50.2, according to a meta-analysis on the impact of statin dose (≥40 mg per day).

Anonymous Patient Answer

Does cardiovascular diseases run in families?

In our cohort of patients, the prevalence of family history of cardiovascular diseases is extremely low confirming the existence of an "environmental" factor contributing to the development of CVD.

Anonymous Patient Answer

How serious can cardiovascular diseases be?

The impact of coronary heart disease and stroke can be disabling. However, the likelihood of stroke and coronary heart disease can be substantially reduced through risk factor modification. However, a major change in lifestyle may have more significant effects. Cardiovascular disease may be the result of a complex interplay between genetic factors and lifestyle. Hence risk factor modification may be less effective when lifestyle modification is attempted in isolation.

Anonymous Patient Answer
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