Recruiting

CardioCare Quest

Sponsor:

Northern Arizona University

Code:

NCT06487637

Conditions

High Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioCare Quest

Study Details

Brief summary:

This project aims to address healthcare disparities among Navaho people diagnosed with hypertension or prehypertension through three main objectives. Firstly, it identifies and shares insights on healthcare access disparities affecting Navaho individuals experiencing nonadherence to hypertension treatment. Secondly, the proposal develops a telehealth solution based on factors identified as knowledge gaps caused by healthcare access disparities in hypertension management; we will use the factors to design a series of engaging minigames that can be incorporated into the larger CardioCare Quest. These minigames will be co-designed with end users and clinicians. Finally, the proposal conducts comprehensive qualitative and quantitative assessments of user experiences, perceptions, and challenges with CardioCare Quest.

Conditions

High Blood Pressure

Study ID

NCT06487637

Start date

Jun 30, 2024

Status verified date

Jun, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • We are interested in interviewing people who receive, give, or are affected by HBP therapy. This includes medical professionals, patients with HBP between the ages of 18 and above, their family members, caretakers, and relevant community professionals such as social workers.
  • The project targets Urban Indigenous individuals in the patient category. A potential participant will be recognized as Urban Indigenous upon completing the registration form provided to them.
  • The project is interested in Navajo Nation groups that reside in Flagstaff.

Exclusion Criteria:

  • Patients with uncontrolled or severely severe hypertension will be excluded from this study since controlling these instances may be the primary emphasis of the study rather than its intervention.
  • The exclusion will be based on considerations such as the severity of hypertension, the potential risks associated with uncontrolled hypertension, and the overall health status of the patient.
  • Participants having specific medical conditions that could interfere with or pose risks to the study's outcomes (e.g., severe heart disease, advanced kidney disease) will be excluded.
  • Pregnant women or those who want to get pregnant during the study period will be excluded due to the potential dangers to both the pregnant woman and the fetus.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Determine the impact of CardioCare Quest's telehealth interventions

This project will employ a mixed methods approach, combining quantitative and qualitative data collection methods within quarters 4 to 8. The quantitative method includes using the Motivation, Engagement, and Thriving in User Experience (METUX), health measures (i.e., blood pressure measurements), and telemetry to assess user engagement, adherence rates, and health outcomes in CardioCare Quest. The qualitative method will be used to identify key constructs such as motivation, engagement, and overall well-being and choose relevant metrics for each construct, including surveys for motivation, thematic analysis of quotes for engagement, and experience sampling for well-being.

Interventions

CardioCare Quest

CardioCare Quest will be the first telehealth game designed to enhance High Blood Pressure (HBP) treatment compliance and education about HBP, featuring a telemetry system that provides physicians and researchers data about sustainable healthy heart lifestyles beyond the clinic. The novelty of CardioCare Quest lies in its ability to compel HBP patients to playfully celebrate the mundane everyday practices that lead to sustainable habits and improved health outcomes using culturally sensitive and community-based design practices.

Primary outcome measure

  • Indigenous ways of knowing hypertension, measured by patient activity workbook using emoji stickers [ Time Frame: Baseline, 6 months ]
  • Indigenous ways of knowing hypertension, measured by Motivation, Engagement, & Thriving in User Experience (METUX) Scale [ Time Frame: Baseline, 6 months ]
  • Change from baseline in Participants' experience score after the design of minigames artifacts integrated into CardioCare Quest on the METUX scales [ Time Frame: Time Frame: Baseline, 7 months ]
  • Quantifying Hypertension Medication Adherence Among People Using Telemetry Data from CardioCare Quest [ Time Frame: Time Frame: End of study, up to 12 months ]

Central Contacts and Locations

Central contacts

Tochukwu Ikwunne, PhD

9282668389tochukwu.ikwunne@nau.edu

Jared Duval, PhD

7744523372jared.duval@nau.edu

Locations

School of Informatics Computing and Cyber Systems

Recruiting

Flagstaff, Arizona, United States, 86001

Contacts

Jared S Duval, PhD

928-523-0429jared.duval@nau.edu

Tochukwu Ikwunne, PhD

9282668389Tochukwu.Ikwunne@nau.edu

Principal Investigator:

Jared Duval, PhD

More Information

Sponsor

Northern Arizona University

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Keywords

  • Medication adherence
  • Co design
  • Game and play
  • Telemetry data
  • diet and exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northern Arizona University on 2025-06-05.