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

Trial Summary

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 data supports the effectiveness of the treatment CardioCare Quest for high blood pressure?

Research shows that lowering blood pressure can significantly reduce major heart-related health problems, regardless of the specific medication used. This suggests that treatments like CardioCare Quest, if effective in lowering blood pressure, could help reduce risks of heart attacks and strokes. ^{1 2 3 4 5}

Is CardioCare Quest safe for humans?

Research on intensive blood pressure treatments, like those in the Systolic Pressure Intervention Trial (SPRINT), shows that while they can lower blood pressure, they may also increase the risk of serious adverse events (SAEs). This suggests that while treatments like CardioCare Quest might be effective, they could also have significant side effects. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Tochukwu Ikwunne, PhD

Principal Investigator

Northern Arizona University

Eligibility Criteria

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

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

Interested in Navajo Nation groups residing in Flagstaff

Exclusion Criteria

My blood pressure is very high and not under control.

My blood pressure is not dangerously high.

I do not have severe heart or advanced kidney disease.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treating to protect: current cardiovascular treatment approaches and remaining needs. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Therapeutic use of lowering blood pressure, especially in mild hypertension. Results of a hypertension detection and treatment program]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Persistence of mortality reduction after the end of randomized therapy in clinical trials of blood pressure-lowering medications. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trials of blood pressure lowering in hypertension: a critical reappraisal. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Treatment of mild hypertension and the problem of compliance. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The World Health Organization--International Society of Hypertension Blood Pressure Lowering Treatment Trialists' Collaboration: prospective collaborative overviews of major randomized trials of blood pressure-lowering treatments. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Check it, change it: a community-based intervention to improve blood pressure control. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes of treating high blood pressure. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of Frequency of Atherosclerotic Cardiovascular and Safety Events With Systolic Blood Pressure [2020]