RecruitingNot ApplicableNCT05671406

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

A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community


Sponsor

University of Texas at Austin

Enrollment

220 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria4

  • 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.

Interventions

BEHAVIORALSensor-controlled digital game

The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid hospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal Hypertension health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app. The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback to motivate engagement in and generate habit formation of heart failure related self-management behaviors.

BEHAVIORALSensor only

Real-time behaviors of physical activity will be tracked by an off-the-shelf sensor and app (Withings). This group will also be provided with standardized evidence-based Hypertension educational material. However, the data from the Withings sensor will not be routed to the SCDG.


Locations(1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

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NCT05671406


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