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Recruiting NCT06487637

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

No phase Interventional High Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CardioCare Quest.
Who it may be relevant to
Registry conditions: High Blood Pressure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Thematic analysis as measured by game design spectra [Time frame: Baseline, 7 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • School of Informatics Computing and Cyber Systems — Flagstaff
  • Northern Arizona University — Flagstaff

Identifiers

NCT: NCT06487637 · 2117583-6 · 5U54MD012388

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗