Digital game to help Native Americans manage hypertension
A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community
This study tests a fun digital game to see if it can help Native American adults with high blood pressure be more active and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05671406 on ClinicalTrials.gov |
What this trial studies
This study evaluates a sensor-controlled digital game designed to motivate physical activity self-management in Native American adults with hypertension. Participants will be divided into two groups: one receiving the digital game and physical activity sensors, and the other receiving only the sensors. The study aims to assess improvements in physical activity behaviors, hypertension knowledge, self-care behaviors, self-efficacy, motivation, and quality of life, as well as reductions in blood pressure and cardiac hospitalizations over a six-month period. The intervention is culturally adapted to better engage the Lumbee tribal community.
Who should consider this trial
Good fit: Ideal candidates are Native American adults aged 18 and older with hypertension who can independently walk and use smartphone technology.
Not a fit: Patients with severe visual or tactile impairments, chronic kidney disease stage 4-5, or terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve hypertension management and overall health outcomes for Native American patients.
How similar studies have performed: While the use of digital games for health management is gaining traction, this specific approach targeting Native American communities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kavita Radhakrishnan, Phd — The University of Texas Austin
- Study coordinator: Jada Brooks, PhD
- Email: jada@email.unc.edu
- Phone: 919-966-9511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.