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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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.

Study sites (1)

NC