Pragmatic Randomized Trial Assessing the Impact of Digital Health Technology on Quality of Life in Patients With Congestive Heart Failure: Design and Rationale

Heart failure is a complex syndrome that contributes significantly to mortality and morbidity in the Unites States. Self-management is an ACC/AHA-recommended management tool for chronic conditions, however, those with congestive heart failure have historically poor compliance, low health literacy, and comorbidities that lead to reduced adherence to therapies and lifestyle modifications. Digital health technologies have the potential to enhance care and improve self-management. 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 the management of congestive heart failure. Leveraging the use of a fully electronic enrollment and consent platform, the trial will randomize 200 patients across heart failure clinics in the Yale New Haven Health system to receive either usual care or one of three distinct digital technologies designed to promote self-management and provide critical data to clinicians. Our primary outcome will measure the change in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months. Initial recruitment efforts have highlighted the large digital divide in our population of interest. Assessing not only clinical outcomes, but patient usability and ease of clinical integration of digital technologies will prove beneficial in determining the feasibility and success of the integration of such technologies into the healthcare system. Future learnings will illustrate strategies to improve patient engagement with, and integration of, digital health technologies to enhance the patient-clinician relationship. Clinicaltrials.govNCT04394754