JMIR Publications

ABSTRACT

Background:

Heart failure (HF) is the leading cause of hospitalization among older adults in the U.S. There are significant racial and geographic disparities in HF outcomes, with patients living in southern U.S. states suffering a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight-monitoring and physical activity, are extremely important in improving HF outcomes, but patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) are a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable, scalable, and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes.

Objective:

This randomized clinical trial (RCT) assesses the efficacy of a sensor-controlled digital game in integrating HF participants’ behavioral data from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors.

Methods:

Two-hundred participants with HF, aged 45 or older, will be recruited and randomized into 2 groups: the SCDG-playing group (IG) and a sensor-only group (CG). Both groups will receive a weight scale, physical activity tracker, and accompanying app, while only the IG will play the SCDG. This design, thereby, assess the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention; they will also complete a 3rd posttest at 24 weeks to assess maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight-monitoring and physical activity) and distal outcomes (HF hospitalization, QoL, functional status) between baseline to weeks 6, 12, and 24. The primary outcome measured will be days with weight-monitoring, for which this design provides at least 80% power to detect differences between the two groups.

Results:

Recruitment began in the fall of 2022, with the first patient enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in Q1 of 2025. Publication of complete results and data from the study is expected in 2026.

Conclusions:

This project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF.