RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community

Quick Facts

Study Start:2024-06-27
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05671406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults in a Native American tribal community in southeastern U.S.
  2. * Age 18 years or older
  3. * Systolic BP ≥140mm Hg and/or diastolic BP ≥90mm Hg on 2 separate measurements or who are on antihypertensive medication will be included.
  4. * Pass a mini-cognitive screen
  5. * Able to independently walk without using a walker or requiring human assistance (ambulation/locomotion item on the Outcome and Assessment Information).
  1. * Severe visual (e.g., legal blindness) or tactile (e.g., severe arthritis) impairments that adversely prevent use of a smart phone or sensor devices;
  2. * Chronic kidney disease stage 4-5,
  3. * Diagnosis of end stage or terminal illness (e.g., cancer or heart failure)
  4. * Prior heart transplantation or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist devise) due to unique self-care needs.

Contacts and Locations

Study Contact

Jada Brooks, PhD
CONTACT
919-966-9511
jada@email.unc.edu
Angelica Rangel, MS
CONTACT
512-956-8714
arangel@nursing.utexas.edu

Principal Investigator

Kavita Radhakrishnan, Phd
PRINCIPAL_INVESTIGATOR
The University of Texas Austin

Study Locations (Sites)

University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

  • Kavita Radhakrishnan, Phd, PRINCIPAL_INVESTIGATOR, The University of Texas Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-06-27
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • hypertension
  • self-care
  • digital game
  • Native American

Additional Relevant MeSH Terms

  • Hypertension