Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation

Abstract

Background Self‐care and patient engagement are important elements of heart failure (HF) care, endorsed in the guidelines. Digital health tools may improve quality of life (QOL) in HF patients by promoting care, knowledge, and engagement. This manuscript describes the rationale and challenges of the design and implementation of a pragmatic randomized controlled trial to evaluate the efficacy of three digital health technologies in improving QOL for patients with HF. Hypothesis We hypothesize that digital health interventions will improve QOL of HF patients through the early detection of warning signs of disease exacerbation, the opportunity of self‐tracking symptoms, and the education provided, which enhances patient empowerment. Methods Using a fully electronic enrollment and consent platform, the trial will randomize 200 patients across HF clinics in the Yale New Haven Health system to receive either usual care or one of three digital technologies designed to promote self‐management and provide critical data to clinicians. The primary outcome is the change in QOL as assessed by the Kansas City Cardiomyopathy Questionnaire at 3 months. Results First enrollment occurred in September 2021. Recruitment was anticipated to last 6–8 months and participants were followed for 6 months after randomization. Our recruitment efforts have highlighted the large digital divide in our population of interest. Conclusion Assessing clinical outcomes, patient usability, and ease of clinical integration of digital technologies will be beneficial in determining the feasibility of the integration of such technologies into the healthcare system.

Digital Solutions to Optimize Guideline-Directed Medical Therapy Prescriptions in Heart Failure Patients: Current Applications and Future Directions

“…NCT04394754 is a RCT evaluating the efficacy of AI-based technology in the treatment of congestive HF. A “smart” scale (Bodyport), an automated conversational platform (Conversa), and a coaching application (Noom) using an AI algorithm are used to determine fluid status noninvasively and assess HF risk [ 70 ]. In total 182 participants are expected to enroll in this study.…”

The role of digital health in the cardiovascular learning healthcare system

“…Validation studies are crucial in not only evaluating the integration of digital health technologies into standard care, but also in assessing the intrinsic validity of measurement tools such as blood pressure and heart rate monitoring devices, where high correlation between manual measurements and wearables shows promising potential particularly in ambulatory medical management ( 51 ). Clinical trials and innovative research programs have also become more notable in understanding the holistic impact disruptive technologies such as smart scales measuring fluid and hemodynamic status, AI-based self-management platforms, and smartphone applications, can have in clinical management as well as quality of life in patients with chronic conditions such as heart failure ( 52 ). The Connected Health Innovation Research Program (C.H.I.R.P.)…”