Recruiting

Digital Game

Sponsor:

University of Texas at Austin

Code:

NCT05671406

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sensor-controlled digital game

Sensor only

Study Details

Brief 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.

Conditions

Hypertension

Study ID

NCT05671406

Start date

Jun 27, 2024

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Sensor-controlled digital game

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

active comparator: Sensor-only

The control group will receive only the physical activity tracker.

Interventions

Sensor-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.

Sensor 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.

Primary outcome measure

  • Mean of Daily Steps on Physical Activity Sensor Logs at 3 months [ Time Frame: 3 months ]
  • Mean of Daily Steps on Physical Activity Sensor Logs at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jada Brooks, PhD

919-966-9511jada@email.unc.edu

Angelica Rangel, MS

512-956-8714arangel@nursing.utexas.edu

Locations

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Jada Brooks, PhD

919-966-9511jada@email.unc.edu

Principal Investigator:

Jada Brooks, PhD

More Information

Sponsor

University of Texas at Austin

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • hypertension
  • self-care
  • digital game
  • Native American

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-01-21.