CardioCare Quest for High Blood Pressure

Recruiting at 1 trial location

Overseen By Jared Duval, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northern Arizona University

Disqualifiers: Severe hypertension, Heart disease, Kidney disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore and address healthcare gaps for Navaho people with high blood pressure (hypertension). Researchers will develop a telehealth tool featuring minigames to enhance treatment understanding and adherence. The trial will collect user feedback to refine the tool and ensure it meets their needs. Suitable participants include those from the Navaho Nation living in Flagstaff who have high blood pressure and wish to help improve healthcare solutions. As an unphased study, this trial allows participants to contribute to innovative healthcare solutions tailored to their community's needs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that CardioCare Quest is safe for Navaho people with hypertension?

Research has shown that digital health tools like CardioCare Quest can help manage high blood pressure. These tools often include telehealth features, which users generally find easy to use. Studies indicate that telemedicine, or healthcare through digital means, can effectively lower blood pressure without causing major side effects.

CardioCare Quest incorporates fun mini-games and telehealth to help people adhere to their treatment plans. This method has been tested before and is considered safe. Although there have been no specific reports of problems with CardioCare Quest, its focus on user engagement and telehealth suggests it poses a low risk.

Overall, CardioCare Quest aims to make managing high blood pressure easier and more accessible, especially for Navajo individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CardioCare Quest because it leverages telehealth interventions to manage high blood pressure in a way that traditional treatments like medications and lifestyle changes cannot. Unlike standard options, CardioCare Quest uses a mixed methods approach, combining data from user experience metrics, health measurements, and telemetry to deeply understand patient engagement and adherence. This innovative method not only aims to improve blood pressure outcomes but also enhances patient motivation and overall well-being through personalized feedback and support, offering a more holistic approach to managing high blood pressure.

What evidence suggests that CardioCare Quest's telehealth interventions are effective for high blood pressure?

Studies have shown that telehealth methods can effectively lower blood pressure in people with hypertension. For example, one study found that telemedicine reduced the systolic blood pressure by about 5.6 points over six months. In this trial, researchers are testing CardioCare Quest to help people adhere to their treatment plans through engaging mini-games and telehealth services. This approach aims to make healthcare more accessible and improve the management of high blood pressure. Early results suggest that these digital tools can enhance motivation and involvement, which are crucial for better health outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Tochukwu Ikwunne, PhD

Principal Investigator

Northern Arizona University

Are You a Good Fit for This Trial?

This trial is for Navaho individuals with high blood pressure or prehypertension. It focuses on those who may have difficulty sticking to their treatment due to healthcare access disparities.

Inclusion Criteria

Project targets Urban Indigenous individuals in the patient category; potential participant recognized as Urban Indigenous upon completing registration form

Interested in Navajo Nation groups residing in Flagstaff

I am involved with high blood pressure therapy, either as a patient, family member, caretaker, medical professional, or community professional.

Exclusion Criteria

Pregnant women or those planning to get pregnant during study period excluded due to potential dangers to both pregnant woman and fetus

My blood pressure is very high and not under control.

My blood pressure is not dangerously high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Game Design and Development

Participants engage in the co-design of minigames and educational modules to enhance hypertension treatment adherence and knowledge.

7 months

Ongoing virtual engagement

Evaluation

Mixed methods approach to evaluate the game's usability, engagement, and utility using METUX scales and telemetry data.

5 months

Quarterly assessments

Follow-up

Participants are monitored for safety and effectiveness after the intervention, focusing on hypertension management and treatment adherence.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CardioCare Quest

Trial Overview The intervention being tested is 'CardioCare Quest,' a telehealth game designed to improve hypertension treatment compliance through engaging minigames co-created with end users and clinicians.

How Is the Trial Designed?

Group I: Determine the impact of CardioCare Quest's telehealth interventions Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In the SPRINT trial, patients with higher baseline cardiovascular disease (CVD) risk benefited more from intensive blood pressure treatment, while those with lower risk experienced more harm than benefit, highlighting the importance of risk stratification in treatment decisions.

The study found that the number needed to treat to prevent primary outcomes decreased significantly with higher CVD risk, while the number needed to harm for serious adverse events increased, indicating a favorable benefit-to-harm ratio for intensive treatment in higher-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. Phillips, RA., Xu, J., Peterson, LE., et al.[2022]

Citations

1. trialstoday.org trialstoday.org/trial/NCT06487637

CardioCare Quest This project aims to address healthcare disparities among Navaho people diagnosed with hypertension or prehypertension through three main ...

2. trialx.com trialx.com/clinical-trials/listings/298907/cardiocare-quest-a-co-created-game-for-improving-hypertension-treatment-compliance-in-arizona/

CardioCare Quest: A Co-created Game for Improving ... Clinical trial for High Blood Pressure , CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/37/NCT06487637/Prot_SAP_000.pdf

Study Protocol and Statistical Analysis Plan Determine the impact of CardioCare Quest's telehealth interventions through a mixed methods approach. Sample Size Determination. We performed ...

4. clinconnect.io clinconnect.io/trials/NCT06487637

CardioCare Quest: A Co-created Game for Improving The CardioCare Quest trial is focused on improving treatment for high blood pressure (hypertension) among Navajo individuals in Arizona. The study aims to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11969891/

Managing cardiovascular risk factors with telemedicine in ... For AH, systolic blood pressure decreased by −5.63 mmHg (95% CI −9.13 to −2.13) at 6 months and −5.59 mmHg (95% CI −10.03 to −1.14) at 12 months ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39523670/

Assessing the impact of telemedicine interventions on ... This study demonstrates that telemedicine interventions significantly reduce both systolic and diastolic blood pressure, ...