NCT06487637 · Northern Arizona University
CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
What this study is about
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.
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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.
Interventions
BEHAVIORAL
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 measures
Indigenous ways of knowing hypertension, measured by patient activity workbook using emoji stickers
Time frame: Baseline, 6 months
Each emoji will be assigned a numerical value based on the emotion it represents (e.g., Very happy emoji = 5, happy emoji = 4, neutral emoji = 3, sad emoji = 2, and very sad emoji = 1). Each day, participants log their experiences using one of the five emoji stickers. At the end of each week, the average score for the week will be calculated by summing the daily scores and dividing by the number of days logged. An overall average score for the entire study period will be calculated by summing the weekly averages and dividing by the number of weeks.
Indigenous ways of knowing hypertension, measured by Motivation, Engagement, & Thriving in User Experience (METUX) Scale
Time frame: Baseline, 6 months
The Motivation, Engagement, \& Thriving in User Experience (METUX) scale helps quantify participants' experiences with the digital intervention. Typically, METUX scales are rated on a Likert scale from 1 to 5, (1: Very negative experience, 2: Negative experience, 3: Neutral experience, 4: Positive experience, and 5: Very positive experience). Higher scores indicate a better outcome, meaning a more positive experience with the digital workbook and hypertension management.
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
The Motivation, Engagement, \& Thriving in User Experience (METUX) scale helps quantify participants' experiences after designing minigames integrated into Cardiocare Quest. METUX scales are rated on a Likert scale from 1 to 5, (1: Very negative experience, 2: Negative experience, 3: Neutral experience, 4: Positive experience, and 5: Very positive experience). Higher scores indicate a better outcome, meaning a more positive experience with the designs of minigames that are integrated into CardioCare Quest.
Quantifying Hypertension Medication Adherence Among People Using Telemetry Data from CardioCare Quest
Time frame: Time Frame: End of study, up to 12 months
CardioCare Quest will have a system through which telemetry data is collected about the number of people and the adherence to medication for hypertension per week. Medication adherence scores are rated on a Likert scale from 1 to 5, (1: Non-Adherent, 2: Partially Adherent, 3: Moderately Adherent, 4: Highly Adherent, and 5: Perfectly Adherent). The highest score indicates that the individual adheres completely to their medication regimen without missing doses, and the lowest score shows that the individual rarely or never takes their medication as prescribed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Flagstaff, Arizona
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2025 · Source of record for eligibility and locations