Digital Game for High Blood Pressure

(N-SCDG Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kavita Radhakrishnan, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Must be taking: Antihypertensives

Disqualifiers: Severe visual impairments, Chronic kidney disease, Terminal illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of physical activity in Native American adults with hypertension (HTN). Half of the participants will receive the SCDG app and physical activity sensors and the other half will receive only the physical activity sensors. Native American participants with hypertension (HTN) in the sensor controlled digital game intervention group will show increased PA behaviors; improved HTN knowledge, self-care behaviors, self-efficacy, motivation, and quality of life (QoL); and larger reduction in systolic and diastolic blood pressure and cardiac hospitalizations at baseline,3 months, and 6 months as compared to participants in the sensor-only control group.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It seems likely that you can continue your antihypertensive medication, as the study includes participants who are already on such medications.

What data supports the effectiveness of the treatment Sensor-controlled digital game for high blood pressure?

Research on a similar digital game for health, eSMART-HD, showed that it helped reduce blood pressure in people with hypertension (high blood pressure) over time. This suggests that digital games can be effective in managing blood pressure. ^{1 2 3 4 5}

Is the digital game treatment safe for humans?

The research on digital games for health, including sensor-controlled games, shows they are generally safe and well-received by participants, with no significant safety concerns reported in studies involving people with high blood pressure and heart failure. ^{1 2 3 5 6}

How does the sensor-controlled digital game treatment for high blood pressure differ from other treatments?

This treatment is unique because it uses a digital game controlled by sensors to motivate real-time behavior changes, offering progress and rewards to encourage self-management of high blood pressure, unlike traditional medication or lifestyle advice. ^{1 2 3 4 7}

Research Team

Kavita Radhakrishnan, PhD

Principal Investigator

The University of Texas Austin

Eligibility Criteria

This trial is for Native American adults living in the southeastern U.S. who have high blood pressure, measured as systolic BP ≥140mm Hg or diastolic BP ≥90mm Hg twice, or those on blood pressure medication. Participants must be over 18, able to walk independently without assistance, and pass a basic cognitive test.

Inclusion Criteria

I passed a short test that checked my thinking skills.

I can walk on my own without help or a walker.

Adults in a Native American tribal community in southeastern U.S.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the sensor-controlled digital game (SCDG) app and physical activity sensors or only the physical activity sensors

6 months

Baseline, 3 months, 6 months

Follow-up

Participants are monitored for changes in hypertension self-efficacy, quality of life, and blood pressure control

4 weeks

Treatment Details

Interventions

• Sensor-controlled digital game (Behavioural Intervention)
• Sensor only (Behavioural Intervention)

Trial Overview The study tests if a sensor-controlled digital game can improve self-care in managing hypertension by increasing physical activity and knowledge about the condition. Half of the participants will use this game with sensors; the other half will only receive sensors to monitor their activity.

Participant Groups

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

The intervention group will receive a sensor-controlled digital game (SCDG) app and physical activity tracker.

Group II: Sensor-only Active Control 1 Intervention

The control group will receive only the physical activity tracker.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

A study involving 116 community-dwelling adults with hypertension tested the eSMART-HD serious game for health, showing significant reductions in both systolic and diastolic blood pressure within the group using the game, although no significant difference was found compared to the control group.

The findings suggest that eSMART-HD may be an effective tool for improving blood pressure control in adults with hypertension, warranting further research to explore its components and effectiveness in larger, more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMPACT OF A SERIOUS GAME FOR HEALTH ON CHRONIC DISEASE SELF-MANAGEMENT: PRELIMINARY EFFICACY AMONG COMMUNITY DWELLING ADULTS WITH HYPERTENSION. Hickman, RL., Clochesy, JM., Pinto, MD., et al.[2015]

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]

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]

The prototype application 'The Heart Game' was tested on 10 heart patients aged 48-89 and their relatives, showing that gamification principles effectively engaged users and supported their telerehabilitation process.

Involving a close relative in the rehabilitation activities not only motivated patients but also enhanced their overall experience, highlighting the potential of social interaction in improving rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The Heart Game": Using Gamification as Part of a Telerehabilitation Program for Heart Patients. Dithmer, M., Rasmussen, JO., Grönvall, E., et al.[2018]

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]

The game 'Heart Sense' has shown promising initial results in improving people's ability to recognize heart attack symptoms, which is crucial for timely treatment.

By encouraging quicker responses to heart attack symptoms, the game has the potential to reduce delays in seeking medical help, ultimately lowering the risks of mortality and morbidity associated with myocardial infarctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer games may be good for your health. Silverman, BG., Holmes, J., Kimmel, S., et al.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

IMPACT OF A SERIOUS GAME FOR HEALTH ON CHRONIC DISEASE SELF-MANAGEMENT: PRELIMINARY EFFICACY AMONG COMMUNITY DWELLING ADULTS WITH HYPERTENSION. [2015]

2. Germany 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. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

"The Heart Game": Using Gamification as Part of a Telerehabilitation Program for Heart Patients. [2018]

5. Netherlands 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Interactive Digital e-Health Game for Heart Failure Self-Management: A Feasibility Study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Computer games may be good for your health. [2007]