Clinical trial NCT06487637: CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
Official title: CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Blood Pressure
Keywords: Medication adherence
Co design
Game and play
Telemetry data
diet and exercise
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: CardioCare Quest is a creative solution to addressing High Blood Pressure (HBP) and improving treatment compliance through a telehealth game, particularly among Navaho populations in Arizona. Integrating a telemetry system is a unique aspect that could offer valuable data on heart-healthy lifestyles in non-traditional clinical settings. The project's primary goals include designing and developing minigames combined with educational modules to enhance HBP treatment adherence and knowledge. Additionally, it seeks to collect preliminary data through a mixed-methods approach to evaluate the game's usability, engagement, and utility. This crucial step precedes the progression towards the R01 application for a comprehensive study evaluating the long-term effectiveness of the game. In Aim 1, the hypothesis is that the resulting affinity diagrams, which prioritize design problem statements, will enable them to share valuable insights on healthcare access disparities. This, in turn, provides crucial knowledge for developing targeted interventions to improve treatment compliance among Indigenous populations. In Aim 2, thematic analysis is applied to codesigned minigame prototypes using an emerging serious game theory. Aim 3 involves using a mixed methods approach to determine the impact of CardioCare Quest's telehealth interventions. The methodology of the CardioCare Quest project involves a participatory design approach that incorporates methods like bodystorming, brainstorming, and affinity diagramming that are tailored to the specific cultural and health needs of Indigenous populations in Arizona. This approach includes developing a series of engaging multiplayer minigames that focus on various aspects of HBP management, like diet, exercise, medication adherence, and lifestyle modifications.

Eligibility criteria: 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.

Primary outcomes:
measure: Indigenous ways of knowing hypertension, measured by patient activity workbook using emoji stickers
timeFrame: Baseline, 6 months
measure: Indigenous ways of knowing hypertension, measured by Motivation, Engagement, & Thriving in User Experience (METUX) Scale
timeFrame: Baseline, 6 months
measure: Change from baseline in Participants' experience score after the design of minigames artifacts integrated into CardioCare Quest on the METUX scales
timeFrame: Time Frame: Baseline, 7 months
measure: Quantifying Hypertension Medication Adherence Among People Using Telemetry Data from CardioCare Quest
timeFrame: Time Frame: End of study, up to 12 months
Secondary outcomes:
measure: Thematic analysis as measured by game design spectra
timeFrame: Baseline, 7 months
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: School of Informatics Computing and Cyber Systems
state: Arizona
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Tochukwu Ikwunne, PhD
role: PRINCIPAL_INVESTIGATOR
References: