CLINICAL TRIAL

Mega Team - video game for Heart Diseases

Recruiting · < 18 · All Sexes · Toronto, Canada

This study is evaluating whether a video game can improve executive functioning in children with developmental disorders.

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About the trial for Heart Diseases

Eligible Conditions
ASD · Attention Deficit Hyperactivity Disorder (ADHD) · Heart Diseases · Heart Defects, Congenital · Congenital Heart Disease (CHD)

Treatment Groups

This trial involves 2 different treatments. Mega Team - Video Game 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.
Mega Team - video game
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Score above 70 on the WASI II or equivalent intelligence tests. show original
This study does not include people who have a diagnosis of autism spectrum disorder or congenital heart disease. show original
The child was diagnosed with ADHD by a referring clinician using DSM 5 criteria, and this was confirmed by a semi-structured interview with the parents show original
Sub-Study 1 Inclusion Criteria
Must be 6-12 years of age
Be able to have reliable access to the internet. show original
Sub-Study 2 inclusion criteria
An individual has an IQ above 70 if their score on two subtests of the Wechsler Abbreviated Scale of intelligence, Second Edition (WASI II) is at least 70 or equivalent. show original
The individual meets the clinical diagnosis of ASD by referral services (Holland Bloorview, CAMH) and is supported by the use of the ADOS assessment tool. show original
Sub-Study 3 inclusion criteria
View All
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, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline).
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 Mega Team - video game will improve 2 primary outcomes and 4 secondary outcomes in patients with Heart Diseases. Measurement will happen over the course of Baseline, Post-training study visit #1 (4-5 weeks after baseline), Post-training study visit #2 (6 months after baseline).

Inattentive and Hyperactivity Behaviour rated by parent and teacher
BASELINE, POST-TRAINING STUDY VISIT #1 (4-5 WEEKS AFTER BASELINE), POST-TRAINING STUDY VISIT #2 (6 MONTHS AFTER BASELINE)
Items associated with inattentiveness and hyperactivity from the SNAP IV will be used to estimate behavioural symptoms associated with ADHD. The SNAP-IV (SNAP-IV; Swanson IV, 2003) is an 18-item scale that includes the DSM-IV criteria for ADHD with items 1-9 representing the inattentive subset of symptoms and items 10-18 representing the Hyperactivity/Impulsivity subset.
Academic accuracy and efficiency
BASELINE, POST-TRAINING STUDY VISIT #1 (4-5 WEEKS AFTER BASELINE), POST-TRAINING STUDY VISIT #2 (6 MONTHS AFTER BASELINE)
Academic efficiency and accuracy will be assessed using the fluency measures from the Woodcock Johnson III30 test of achievement. The fluency tasks measure the accuracy of completing academic tasks within a time limit. Reading, math and writing fluency subtests will be included.
Planning and Organization
BASELINE, POST-TRAINING STUDY VISIT #1 (4-5 WEEKS AFTER BASELINE), POST-TRAINING STUDY VISIT #2 (6 MONTHS AFTER BASELINE)
The Tower Test from the Delis-Kaplan Executive Function System (D-KEFS;28 is a test of planning and problem solving abilities. Participants are asked to construct towers of discs on a set of pegs corresponding to a model. Raw scores reflect the participant's ability to use the fewest possible moves to achieve the tower depicted in the model.
Change in Response Inhibition
BASELINE, POST-TRAINING STUDY VISIT #1 (4-5 WEEKS AFTER BASELINE), POST-TRAINING STUDY VISIT #2 (6 MONTHS AFTER BASELINE)
Inhibitory control will be measured using the Stop Signal Task (SST). The SST measures the ability to cancel an already initiated motor response. The primary outcome measure will be the participants' average stop signal reaction time (SSRT).
Everyday functioning and impairment
BASELINE, POST-TRAINING STUDY VISIT #1 (4-5 WEEKS AFTER BASELINE), POST-TRAINING STUDY VISIT #2 (6 MONTHS AFTER BASELINE)
Parent and teacher rating of behaviours and impairments associated with executive functions will be assessed using The Behavior Rating Inventory of Executive Function (BRIEF;29). This is a 86 item questionnaires with solid psychometric properties (ref) with correlations with other measures of emotional and behavioral functioning29.
Change in Working Memory
BASELINE, POST-TRAINING STUDY VISIT #1 (4-5 WEEKS AFTER BASELINE), POST-TRAINING STUDY VISIT #2 (6 MONTHS AFTER BASELINE)
Verbal and Spatial N-back (1, 2 conditions) will be used to assess central executive working memory. The N-Back task requires on-line monitoring, updating, and manipulation of information and measures key processes within working memory. In the N-Back task, the participant is required to monitor a series of stimuli and to respond whenever a stimulus is presented that is the same as the one presented n trials previously, where n is a pre-specified integer, usually 0, 1, or 2. The current study will use letters (verbal) and spatial location (spatial) paradigms. Visual and spatial working memory span will be assessed using the Spatial Span subtest and the Digit Span item from the WISC-IV Integrated. The primary outcome measure will be the overall score.

Who is running the study

Principal Investigator
J. C.
Jennifer Crosbie, Clinical Scientist/Psychologist
The Hospital for Sick Children

Patient Q & A Section

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

Can heart diseases be cured?

Most cases of heart failure, congestive heart failure, myocardial infarction (heart attack, heart attack), arrhythmias, and pericarditis are potentially curable, but some are possibly incurable if not treated. We suggest that, to achieve the most maximal potential cure rate out of all those conditions, both disease-specific treatments and specific therapies to achieve remission should be made a goal.

Anonymous Patient Answer

What causes heart diseases?

The prevalence of heart disease seems to continue to rise; however, one would expect more information to be present in the health records and a better understanding of risk factors for heart disease. Many risk factors seem unlikely to be influenced by public health measures but are likely to evolve over time. The role that genes and genes for diseases affect the heart has yet to be discovered.

Anonymous Patient Answer

What are common treatments for heart diseases?

The use of heart products and devices, along with surgery to correct the heart, are some treatments for heart disease. In addition, some patients also receive blood transfusions to replenish all of the patient's blood lost over the past 2 to 3 months. Many patients with heart disease also receive medications to slow the progression of the disease. Additionally, patients on anticoagulant therapy for atrial or ventricular fibrillation may need to be treated with new anticoagulant drugs that have been found to be more effective when used in the early stages of treatment. Finally, many patients also receive treatments to prevent future heart attacks and strokes.

Anonymous Patient Answer

What are the signs of heart diseases?

It is important that people get the right assessment for their symptoms. In our opinion, a combination of symptoms or signs that point to heart disease is called a syndrome. There are many such syndromes that are associated with heart disease and they include [non-specific or unspecified chest pain or discomfort, palpitations, fatigue, shortness of breath, feeling the heart beating too fast, ankle swelling, chest pain that feels like heaviness, feeling the heartbeat, chest pain with movement, swelling in the back or limbs, unexplained loss of bone or muscle mass, trouble sleeping, or anxiety about the seriousness of the symptoms]. These warning signs are a useful guide to getting a more detailed examination or diagnostic testing when it is needed.

Anonymous Patient Answer

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

About 2 million of the total number of American men in the age 45 to 64 year of age, would be diagnosed with coronary and/or Peripheral arterial disease. As the incidence of heart diseases increases, the annual death for these diseases probably is increasing.

Anonymous Patient Answer

What is heart diseases?

Heart diseases have been associated with increased incidence of cerebrovascular disease (CVD) and reduced incidence of diabetes in women. The high incidence of heart diseases among Pakistani men in this study suggests that this population may be developing a high cardiovascular risk profile, particularly with regard to developing atherosclerotic heart disease.

Anonymous Patient Answer

How does mega team - video game work?

Mega team - video game may be a good strategy for increasing cardiac rehabilitation (RR, BP, and HR) and cardiac rehabilitation adherence among patients with heart disease.

Anonymous Patient Answer

How serious can heart diseases be?

The number of patients with more than two chronic conditions is increasing and there seem to be a progressive increase in the number of patients with more serious chronic heart diseases and in the number of deaths from cardiovascular deaths.

Anonymous Patient Answer

Is mega team - video game typically used in combination with any other treatments?

Mega team is a new term being used when describing the use of modern digital technology in health practices, which provides electronic patient records, databases and tools for medical practice such as practice guidelines and electronic medical records. Digital tools have been used in combination with medical treatment and in many cases they are considered a core component of the treatment. However, in many cases there is no evidence for the use of digital tools in combination with other standard medical treatments such as exercise and physical activity. Thus, it is not known whether digital tools used in combination with other treatment options are beneficial. In many studies of digital tools this question has not been answered.

Anonymous Patient Answer

Have there been other clinical trials involving mega team - video game?

Clinical trial in this series did not have a significant role to support the video game use in patients with clinical conditions. Data from a recent study can be interpreted as that the patients without clinical condition may not be suitable for our clinical trials by a combination game.

Anonymous Patient Answer

Has mega team - video game proven to be more effective than a placebo?

The Mega Team proved to be effective and safe procedure which can be considered as a supplementary treatment in patients with stable cardiac diseases. The Mega Team is a simple and easy-to-play video game which enhances self-awareness and communication skills of patients. The aim of the study is to evaluate the efficacy of a video game against a virtual reality placebo session.

Anonymous Patient Answer

What is the average age someone gets heart diseases?

The average age someone dies from heart diseases is 66.9 for females (compared to 63.5 for males) and 78.4 in the top one-third of the age distributions (compared to 78.8 in the bottom one-third of the age distributions only among females). In the United States, approximately 19,300 men and 11,500 women die each year owing to heart diseases. Although there is a growing burden of heart disease risk factor burden among U.S.-born immigrants, they remain undertreated by health care professionals.

Anonymous Patient Answer
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