NCT05671406

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
11mo left

Started Jun 2024

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jun 2024Mar 2027

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 27, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

January 2, 2023

Last Update Submit

January 19, 2026

Conditions

Hypertension

Keywords

hypertensionself-caredigital gameNative American

Outcome Measures

Primary Outcomes (2)

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

    This outcome measure will be measured by calculating the average daily steps at end of 3 months. These measures will be collected from sensor logs within the apps for both IG and CG.

    3 months

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

    This outcome measure will be measured by calculating the average daily steps at end of 6 months. These measures will be collected from sensor logs within the apps for both IG and CG.

    6 months

Secondary Outcomes (16)

  • Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.

    Baseline, 3 months

  • Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.

    Baseline, 6 months

  • Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.

    Baseline, 3 months

  • Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.

    Baseline, 6 months

  • Change from baseline in mean Blood Pressure Control at 3 months

    Baseline, 3 months

  • +11 more secondary outcomes

Study Arms (2)

Sensor-controlled digital game

EXPERIMENTAL

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

Behavioral: Sensor-controlled digital game

Sensor-only

ACTIVE COMPARATOR

The control group will receive only the physical activity tracker.

Behavioral: Sensor only

Interventions

Sensor-controlled digital gameBEHAVIORAL

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.

Also known as: SCDG
Sensor-controlled digital game
Sensor onlyBEHAVIORAL

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.

Sensor-only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (1)

  • Radhakrishnan K, Im CR, Brooks JL, Fallon GC, Rangel A, Julien C, O'Hair M, Liang H, Lowe J. Sensor-controlled digital game for Native American adults in the Lumbee Tribe with hypertension self-management: study protocol for a randomized controlled trial. Trials. 2025 Sep 1;26(1):329. doi: 10.1186/s13063-025-09026-y.

    PMID: 40890750DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kavita Radhakrishnan, Phd

    The University of Texas Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jada Brooks, PhD

CONTACT

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

Angelica Rangel, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

June 27, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

US(1)