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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of Texas at Austin
Study ID
NCT05671406
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sensor-controlled digital game — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 27, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina Chapel HillChapel HillNorth Carolina27599
Jada Brooks, PhD
[email protected]
919-966-9511
Gail Currin
Jada Brooks, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of North Carolina Chapel Hill· Chapel Hill, NC

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