Digital Game for Heart Failure

(SCDG Trial)

Overseen By Kavita Radhakrishnan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Renal failure, Terminal illness, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a fun digital game that uses sensors to help people with heart failure manage their weight and stay active. The goal is to determine if the Sensor-controlled digital game (SCDG) improves self-care habits compared to using only the sensors. It suits those hospitalized for heart failure in the past year who can perform some physical activities without discomfort. Participants should be comfortable using a smartphone and able to walk without support. As an unphased trial, this study provides a unique opportunity to explore innovative self-care methods and contribute to advancing heart failure management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this sensor-controlled digital game is safe for heart failure patients?

Research has shown that sensor-controlled digital games (SCDGs) are generally safe for people with heart failure. In past studies, these games helped individuals manage their health by promoting regular exercise and weight checks, without causing major side effects. No adverse events were directly linked to using these games.

Digital tools like SCDGs are designed to promote healthy habits and improve heart health. The technology aims to engage users safely and effectively. Although the studies do not provide exact safety statistics, the absence of negative side effects suggests that SCDGs are safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sensor-controlled digital game (SCDG) for heart failure because it offers a unique, interactive approach to managing the condition. Unlike traditional treatments that primarily focus on medication and lifestyle changes, this digital game combines engaging gameplay with real-time feedback from weight and physical activity sensors. This innovative method not only promotes consistent monitoring but also encourages patients to stay active and engaged with their health. By turning health management into an interactive experience, the SCDG could potentially improve patient adherence and outcomes in a fun and motivating way.

What evidence suggests that this digital game is effective for heart failure?

Research shows that playing a sensor-controlled digital game (SCDG), which participants in this trial may receive, helps people with heart failure improve self-care. Studies indicate that this type of game boosts confidence in managing heart failure by encouraging regular weight checks and physical activity. These actions are crucial for controlling heart failure symptoms. Early findings suggest that these games make self-care more engaging, potentially leading to better health outcomes. The game uses sensors to track progress, helping users stay motivated and consistent with their care. Meanwhile, another group in this trial will receive only the weight monitoring and physical activity sensors, serving as a control to evaluate the SCDG's effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Kavita Radhakrishnan, PhD

Principal Investigator

The University of Texas Austin

Are You a Good Fit for This Trial?

Adults over 45 with heart failure that allows for minimal physical activity, who have been hospitalized for it in the past year. They must speak English, pass a cognitive test, and be able to walk without support. Those with severe visual/tactile impairments, renal failure, terminal illnesses or who've had certain heart procedures are excluded.

Inclusion Criteria

I can walk on my own without needing a cane or walker.

I am 45 years old or older.

I was hospitalized for heart failure in the last year.

Exclusion Criteria

Your vision or ability to touch things is severely impaired, making it difficult for you to use a smartphone or sensor devices.

I have had kidney failure that worsens my heart failure prognosis.

I have been diagnosed with a terminal illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the sensor-controlled digital game (SCDG) app and sensors for weight monitoring and physical activity for heart failure self-management

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sensor-controlled digital game (SCDG)
• Sensor Only

Trial Overview

The trial is testing if a sensor-controlled digital game can improve self-management in heart failure patients by encouraging weight monitoring and exercise. Participants are randomly divided into two groups: one uses the game with sensors; the other uses only sensors.

How Is the Trial Designed?

Group I: Sensor-controlled digital game (SCDG) Experimental Treatment 1 Intervention

The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors

Group II: Sensors-only Active Control 1 Intervention

The control group will receive only the weight monitoring and physical activity sensors

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A prototype serious digital game designed for older adults significantly improved their knowledge about heart failure self-management, as shown in a study with 19 participants who found the game enjoyable and easy to play.

Usability testing indicated that nearly all participants found the game helpful for learning about heart failure, suggesting that digital games can be an effective tool for educating older adults with lower education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Digital e-Health Game for Heart Failure Self-Management: A Feasibility Study. Radhakrishnan, K., Toprac, P., O'Hair, M., et al.[2018]

A prototype of a sensor-controlled digital game (SCDG) was tested by 10 older adults with heart failure, who played it for an average of 6 out of 7 days, indicating good usability and engagement.

Participants reported that the SCDG was interesting and easy to use, with an average step count of 4,117 steps per week, suggesting it may effectively motivate physical activity and improve self-management of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Sensor-Controlled Digital Game to Engage Older Adults with Heart Failure in Physical Activity and Weight Monitoring. Radhakrishnan, K., Julien, C., O'Hair, M., et al.[2021]

An interactive digital e-health game (IDEG) was developed to improve self-management in older patients with heart failure, which is crucial since effective self-management can reduce hospitalizations by up to 50%.

Usability testing showed that 5 out of 6 participants found the game interesting, enjoyable, and helpful, indicating that such digital tools can be both feasible and acceptable for older adults with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Older Adults with Heart Failure on Playing an Interactive Digital e-Health Game (IDEG) for Learning About Heart Failure (HF): Prototype Development and Usability Testing. Radhakrishnan, K., Toprac, P., O'Hair, M., et al.[2018]

A qualitative study involving 15 older adults with heart failure showed that 80% found sensor-controlled digital games (SCDGs) acceptable for managing their condition, highlighting their potential as engaging health tools.

Participants suggested features for SCDGs, such as game characters and incentives, emphasizing that these games could help them track behaviors, learn management strategies, and empower their health self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing Sensor-Controlled Digital Gaming to Self-Management Needs of Older Adults with Heart Failure: A Qualitative Study. Radhakrishnan, K., Baranowski, T., O'Hair, M., et al.[2021]

Digital games can effectively enhance patient education and motivation for self-care behaviors in heart failure management, addressing challenges like lack of knowledge and motivation.

The development of a sensor-controlled digital game (SCDG) allows gameplay to be influenced by real-life self-care actions, potentially increasing engagement in important health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Sensor-Controlled Digital Game for Heart Failure Self-Care Based on Behavioral Change Frameworks. Radhakrishnan, K., DeMain, AS., Julien, C., et al.[2023]

The study involved 38 older adults with heart failure, comparing a sensor-controlled digital game (SCDG) intervention to a sensors-only approach over 12 weeks, showing that the SCDG was feasible and well-accepted for encouraging daily weight monitoring and physical activity.

Participants using the SCDG demonstrated a strong correlation between app engagement and adherence to weight monitoring and physical activity, suggesting that gamification can effectively motivate health behaviors in older adults with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. Radhakrishnan, K., Julien, C., Baranowski, T., et al.[2022]

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Digital Game for Heart Failure (SCDG Trial)

Research shows that sensor-controlled digital games (SCDGs) can motivate people with heart failure to engage in important self-care activities like physical ...