Digital Game for High Blood Pressure

(N-SCDG Trial)

Overseen By Jada Brooks, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must be taking: Antihypertensives

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

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital game designed to help Native American adults with hypertension manage their condition through increased physical activity. Participants will receive either the sensor-controlled digital game with physical activity sensors or just the sensors. The trial aims to determine if the game can improve knowledge, self-care, motivation, and quality of life, while also reducing blood pressure and hospital visits. The trial seeks Native American adults with high blood pressure who can walk without assistance and live in a tribal community in the southeastern U.S. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hypertension management in their communities.

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 prior data suggests that this digital game is safe for Native American adults with hypertension?

Research has shown that sensor-controlled digital games (SCDG) have improved health in patients with heart failure. These studies explored how SCDG can assist with self-care activities like exercise and weight monitoring. Although specific safety information for SCDG in individuals with high blood pressure is lacking, these digital tools are generally considered safe. Similar research has reported no major negative effects.

Since this trial tests a digital game rather than a new drug or procedure, the risks are usually low. Participants often experience little to no side effects, making SCDG a potentially safe option for those seeking to manage high blood pressure through increased activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sensor-controlled digital game treatment for high blood pressure because it introduces an innovative, interactive method to help manage the condition. Unlike traditional treatments that rely on medications such as ACE inhibitors or beta-blockers, this digital game uses a sensor to engage users in a way that could make lifestyle changes, like increasing physical activity, more appealing and fun. The physical activity tracker adds another layer, allowing users to monitor their progress and make real-time adjustments. This approach could lead to better long-term adherence to healthy habits, offering a unique complement to existing treatment options.

What evidence suggests that this digital game is effective for managing high blood pressure?

Research shows that digital games can encourage more physical activity, which is crucial for managing high blood pressure. In this trial, one group of participants will use a sensor-controlled digital game (SCDG) app along with a physical activity tracker. Past studies found that Native American adults who played sensor-controlled digital games increased their daily walking. This rise in activity often aids in controlling blood pressure. These games also enhance health knowledge, self-care habits, and motivation. Overall, using these digital games is associated with a better quality of life and fewer hospital visits for heart issues. ^{1 6 7 8 9}

Who Is on the Research Team?

Kavita Radhakrishnan, PhD

Principal Investigator

The University of Texas Austin

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sensor-controlled digital game
• Sensor only

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.

How Is the Trial Designed?

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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 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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12403476/

Sensor-controlled digital game for Native American adults in ... The primary outcome is the mean daily step count, recorded by the activity tracker at 3 and 6 months. Secondary outcomes include systolic blood ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05671406/rct-of-sensor-controlled-digital-game-for-hypertension-self-care-in-a-native-american-community

RCT of Sensor-controlled Digital Game for Hypertension ... This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of physical activity in Native American ...

3. vtechworks.lib.vt.edu vtechworks.lib.vt.edu/items/1b96f8cd-a90a-415a-84df-525d246d7898

Sensor-controlled digital game for Native American adults in ... The primary outcome is the mean daily step count, recorded by the activity tracker at 3 and 6 months. Secondary outcomes include systolic blood ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05671406

RCT of Sensor-controlled Digital Game for Hypertension ... This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of physical activity in Native American adults with ...

5. withpower.com withpower.com/trial/phase-hypertension-5-2023-24050

Digital Game for High Blood Pressure (N-SCDG Trial) The research on digital games for health, including sensor-controlled games, shows they are generally safe and well-received by participants, with no ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40890750/

Sensor-controlled digital game for Native American adults ... The findings will provide vital data on the impact of digital health interventions to improve HTN outcomes and advance health equity in ...

7. researchgate.net researchgate.net/publication/395177688_Sensor-controlled_digital_game_for_Native_American_adults_in_the_Lumbee_Tribe_with_hypertension_self-management_study_protocol_for_a_randomized_controlled_trial

(PDF) Sensor-controlled digital game for Native American ... The primary outcome is the mean daily step count, recorded by the activity tracker at 3 and 6 months. Secondary outcomes include systolic blood ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05056129

Sensor-controlled Digital Game for Heart Failure Self ... This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in ...

9. researchprotocols.org researchprotocols.org/2023/1/e45801/

Sensor-Controlled Digital Game for Heart Failure Self- ... This randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity ...