CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona

NCT06487637 | Recruiting DMC

• 2 other identifiers: 2117583-65U54MD012388
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Indigenous ways of knowing hypertension, measured by patient activity workbook using emoji stickers

  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.

  Baseline, 6 months

• Indigenous ways of knowing hypertension, measured by Motivation, Engagement, & Thriving in User Experience (METUX) Scale

  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.

  Baseline, 6 months

• Change from baseline in Participants' experience score after the design of minigames artifacts integrated into CardioCare Quest on the METUX scales

  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.

  Time Frame: Baseline, 7 months

• Quantifying Hypertension Medication Adherence Among People Using Telemetry Data from CardioCare Quest

  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.

  Time Frame: End of study, up to 12 months

Secondary Outcomes (1)

• Thematic analysis as measured by game design spectra

  Baseline, 7 months

Study Arms (1)

Determine the impact of CardioCare Quest's telehealth interventions

EXPERIMENTAL

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.

Behavioral: CardioCare Quest

Interventions

CardioCare Quest BEHAVIORAL

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.

Determine the impact of CardioCare Quest's telehealth interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northern Arizona University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

School of Informatics Computing and Cyber Systems

Flagstaff, Arizona, 86001, United States

RECRUITING

Northern Arizona University

Flagstaff, Arizona, 86005, United States

NOT YET RECRUITING

Related Links

• The link is about PI and CO PI.

MeSH Terms

Conditions

Hypertension; Medication Adherence; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Tochukwu Ikwunne, PhD

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tochukwu Ikwunne, PhD

CONTACT

9282668389; tochukwu.ikwunne@nau.edu

Jared Duval, PhD

CONTACT

7744523372; jared.duval@nau.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 5, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data from this project will be available after data collection and for five years after the project ends.
• Access Criteria: The project will generate several data types, including software, cardiovascular data, telemetry, project documentation, design recommendations, evaluations, approaches, methodologies, and publications. Experimental assessment and validation are key components of the proposal. Such experiments will involve human subjects. Digital data will be stored in secure Google Team Drives and cloud storage owned by Northern Arizona University. These services require multifactor authentication and support differentiated access using IAM roles to restrict access to data to necessary personnel. Data for the mobile application will be represented in JSON formats or as blob files and stored in Google Firebase using a Northern Arizona University account.

Locations

US (2)