Digital Game for High Blood Pressure (N-SCDG Trial)

N/A

Recruiting

Led By Kavita Radhakrishnan, Phd

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pass a mini-cognitive screen

Able to independently walk without using a walker or requiring human assistance (ambulation/locomotion item on the Outcome and Assessment Information).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates a digital game with sensors to help Native American adults with high blood pressure (HTN) engage in physical activity. Half of the participants will use the digital game and sensors, while the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves a digital game and physical activity monitoring rather than medication, side effects are minimal but may include discomfort from wearing sensors or frustration with using new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I passed a short test that checked my thinking skills.

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean of Daily Steps on Physical Activity Sensor Logs at 3 months

Mean of Daily Steps on Physical Activity Sensor Logs at 6 months

Secondary study objectives

Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 3 months

Change From Baseline in Hypertension Knowledge as measured by the Hypertension Knowledge-Level Scale (HK-LS) at 6 months

Change From Baseline in Hypertension self-care behaviors as measured by the hypertension behavior subscale of the High Blood Pressure Hypertension Self-Care Profile (HBP-SCP) at 3 months

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