High Blood PressureNCT06487637
CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
A study testing CardioCare Quest in people with High Blood Pressure, run by Northern Arizona University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- CardioCare Quest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
School of Informatics Computing and Cyber Systems
Flagstaff, Arizona, 86001
Jared S Duval, PhD, 928-523-0429, jared.duval@nau.edu
Tochukwu Ikwunne, PhD, 9282668389, Tochukwu.Ikwunne@nau.edu
- Not yet recruiting
Northern Arizona University
Flagstaff, Arizona, 86005
Tochukwu Ikwunne, 928-266-8389, tochukwu.ikwunne@nau.edu
Tochukwu Ikwunne, PhD
About this study
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.
Read the 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.
- Conditions
- High Blood Pressure
- Being tested
- CardioCare Quest
- Keywords
- Medication adherence, Co design, Game and play, Telemetry data, diet and exercise
- Medical subject headings
- Hypertension, Medication Adherence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioCare QuestBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CardioCare Quest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time Frame: End of study, up to 12 months
Secondary outcomes (1)
Thematic analysis as measured by game design spectra
The secondary outcome involves thematically analyzing the codesigned prototypes to contribute to emerging serious game theory by using serious game design theory spectra.
Measured: Baseline, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start30 Jun 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Tochukwu Ikwunne, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487637
- Sponsor's protocol ID
- 2117583-6
- Other IDs
- 5U54MD012388
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All resulting publications from this project will be made available as open source for the general public to access the research. A website will be developed and host resources resulting from the project. The information on the website will be written in a digestible format free of jargon. In addition, we will organize workshops and seminars at Northern Arizona University to share our findings with the local communities, especially targeting healthcare providers, students, and community leaders. These sessions will include interactive discussions and Q\&A segments to ensure that community members fully understand the implications of our findings.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
- ClinicalTrials.gov ID
- NCT06487637
- Acronym / sponsor ID
- 2117583-6
- Conditions
- High Blood Pressure
- Keywords
- Medication adherence, Co design, Game and play, Telemetry data, diet and exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Determine the impact of CardioCare Quest's telehealth interventions | Experimental | Behavioral: CardioCare QuestThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioCare QuestCardioCare 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. | Behavioural | Determine the impact of CardioCare Quest's telehealth interventions |
Primary outcome
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.
1 secondary outcome
Thematic analysis as measured by game design spectra
Time frame: Baseline, 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- The link is about PI and CO PI.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All resulting publications from this project will be made available as open source for the general public to access the research. A website will be developed and host resources resulting from the project. The information on the website will be written in a digestible format free of jargon. In addition, we will organize workshops and seminars at Northern Arizona University to share our findings with the local communities, especially targeting healthcare providers, students, and community leaders. These sessions will include interactive discussions and Q\&A segments to ensure that community members fully understand the implications of our findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tochukwu Ikwunne, PhD principal investigator
Northern Arizona University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioCare Quest in people with High Blood Pressure, run by Northern Arizona University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tochukwu Ikwunne, PhD (9282668389, tochukwu.ikwunne@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indigenous ways of knowing hypertension, measured by patient activity workbook using emoji stickers (time frame: Baseline, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.