CardioCare Quest: A Co-created Game for Improving Hypertension Treatment Compliance in Arizona
Phase: NA
Conditions: High Blood Pressure
Sponsor: Northern Arizona University

 
 
 
 
 
 
 
 
 
CARDIOCARE QUEST: A CO-CREATED GAME FOR IMPROVING HYPERTENSION TREATMENT 
COMPLIANCE IN ARIZONA 
 
April 14, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol and Statistical Analysis Plan 
 
Study Protocol: 
Study Population 
The study will enroll a total of 60 participants across three aims: 
Aim 1. Employ Research through Design (RtD) methodologies to co-create culturally 
grounded design problem statements prioritizing healthcare access disparities 
among Navaho Nation Indigenous populations. 
Aim 2. Employ thematic analysis of codesigned minigame prototypes using (and 
contributing to) an emerging serious game theory. 
 
Aim 3. Determine the impact of CardioCare Quest's telehealth interventions through a 
mixed methods approach. 
 
Sample Size Determination 
We performed a power analysis using a t-test for one sample to make sure the study 
is sufficiently powered to detect significant differences. The parameters for this 
analysis were carefully chosen based on relevant published data [1]. Specifically, we 
focused on hypertension prevalence in Navaho populations in Arizona. 
 
 
Statistical Analysis Plan: 
The following parameters were used for the power analysis: 
Test Type: Two-tailed t-test for means from one sample. 
Effect Size: 0.62, based on differences observed in previous studies. 
Alpha Level (Error Probability): 0.05, which is the standard threshold for statistical 
significance. 
Power: 0.90, indicating a 90% probability of detecting a true effect if it exists. 
 
We determined that a sample size of 30 participants per group (totalling 60 
participants) is sufficient, using the above parameters. This sample size is expected 
to provide statistically significant results, ensuring that the study can robustly test the 
hypotheses and draw meaningful conclusions about the differences in hypertension 
prevalence and characteristics among the targeted populations. 
 
Justification of Sample Size 
The choice of an effect size of 0.62 is justified by its relevance to the expected 
differences in hypertension prevalence and characteristics between the populations 
being studied. The high power of 0.90 ensures that the study has a strong likelihood 
of detecting true differences of hypertension prevalence and minimizing the risk of 
Type II errors. The use of a two-tailed test reflects the bidirectional nature of our 
hypotheses, accommodating the possibility of differences in either direction. 
 
In summary, the proposed statistical design, including the determination of sample 
size, is based on rigorous power analysis and is designed to yield reliable and valid 
results, contributing valuable insights into the prevalence and characteristics of 
hypertension among Navaho populations. 

References 
 
[1] Harmon, M.E., Campen, M.J., Miller, C., Shuey, C., Cajero, M., Lucas, S., 
Pacheco, B., Erdei, E., Ramone, S., Nez, T. and Lewis, J. 2016. Associations of 
Circulating Oxidized LDL and Conventional Biomarkers of Cardiovascular Disease in 
a Cross-Sectional Study of the Navajo Population. PloS One. 11, 3 (2016), 
e0143102. DOI:https://doi.org/10.1371/journal.pone.0143102.