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Randomized Controlled Trial
. 2022 Aug;45(8):839-849.
doi: 10.1002/clc.23848. Epub 2022 Jul 12.

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

Angela M Victoria-Castro  1 , Melissa Martin  1 , Yu Yamamoto  1 , Tariq Ahmad  2 , Tanima Arora  1 , Frida Calderon  1 , Nihar Desai  2 , Brett Gerber  1 , Kyoung A Lee  1 , Daniel Jacoby  2 , Hannah Melchinger  1 , Andrew Nguyen  1 , Melissa Shaw  1 , Michael Simonov  1 , Alyssa Williams  3 , Jason Weinstein  1 , Francis P Wilson  1   4
Affiliations
Randomized Controlled Trial

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

Angela M Victoria-Castro et al. Clin Cardiol. 2022 Aug.

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.

Keywords: digital health technology; heart failure.

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Conflict of interest statement

Francis P. Wilson: Founder of Efference, LLC, a medical communications company. Receives support from NIH R01DK113191, R01HS027626, P30DK079310. Nihar Desai: Under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures used for public reporting and pay for performance programs. Reports research grants and consulting for Amgen, Astra Zeneca, Boehringer Ingelheim, Cytokinetics, MyoKardia, Relypsa, Novartis, and SCPharmaceuticals.

Figures

Figure 1
Figure 1
Important elements of the Bodyport physician‐facing dashboard. (A) Global dashboard displaying overall trends and alerts. (B) Detailed individual patient data showing trends in weight and perfusion. (C) Advanced metrics of cardiovascular function. (D) Representative Bodyport Cardiac Scale.
Figure 2
Figure 2
Top panel: Example “chat” for a heart failure educational module. Bottom panel: Example of the physician‐facing Conversa dashboard with a view of patient responses over time.
Figure 3
Figure 3
Representative Noom interface displaying daily program activities (left panel), educational programming (middle panel), and nutrient logging (right panel).
Figure 4
Figure 4
Trial profile. Patients are recruited from Yale outpatient heart failure (HF) clinics and randomized to one of three digital health interventions or usual care. They are then followed for 180 days with both clinic and telephone visits. The primary outcome is change in the Kansas City Cardiology Questionnaire (KCCQ) at 90 days.
See this image and copyright information in PMC

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