NCT05671406Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 2 Jan 2023
- Start date
- 27 Jun 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University of Texas at Austin
- Diseases
- High blood pressure
- NCT number
- NCT05671406
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 27 Jun 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior heart transplantation or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist devise) due to unique self-care needs.
Other illness
- Chronic kidney disease stage 4-5,
- Diagnosis of end stage or terminal illness (e.g., cancer or heart failure)
Other
- Severe visual (e.g., legal blindness) or tactile (e.g., severe arthritis) impairments that adversely prevent use of a smart phone or sensor devices;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.