RCT of Sensor-controlled Digital Game for Hypertension Self-care in a Native American Community

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas at Austin

About 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.

Eligibility criteria

Qualifiers

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

Age 18 years or older

Systolic BP ≥140mm Hg and/or diastolic BP ≥90mm Hg on 2 separate measurements or who are on antihypertensive medication will be included.

Pass a mini-cognitive screen

Disqualifiers

Severe visual (e.g., legal blindness) or tactile (e.g., severe arthritis) impairments that adversely prevent use of a smart phone or sensor devices;

Chronic kidney disease stage 4-5,

Diagnosis of end stage or terminal illness (e.g., cancer or heart failure)

Prior heart transplantation or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist devise) due to unique self-care needs.

Trial design

Treatments tested in this trial

  • Sensor-controlled digital game
  • Sensor only

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Texas at Austin

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator