1. Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease - a randomized clinical trial.
- Author
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Öner A, Dittrich H, Arslan F, Hintz S, Ortak J, Brandewiede B, Mann M, Krockenberger K, Thiéry A, Ziegler A, and Schmidt C
- Subjects
- Humans, Pandemics, Prospective Studies, Chronic Disease, Cardiovascular Diseases therapy, COVID-19 therapy, Atrial Fibrillation therapy, Hypertension therapy, Heart Failure therapy, Stroke, Myocardial Infarction
- Abstract
Importance: Healthcare concepts for chronic diseases based on tele-monitoring have become increasingly important during COVID-19 pandemic., Objective: To study the effectiveness of a novel integrated care concept (NICC) that combines tele-monitoring with the support of a call centre in addition to guideline therapy for patients with atrial fibrillation, heart failure, or treatment-resistant hypertension., Design: A prospective, parallel-group, open-label, randomized, controlled trial., Setting: Between December 2017 and August 2019 at the Rostock University Medical Center (Germany)., Participants: Including 960 patients with either atrial fibrillation, heart failure, or treatment-resistant hypertension., Interventions: Patients were randomized to either NICC (n = 478) or standard-of-care (SoC) (n = 482) in a 1:1 ratio. Patients in the NICC group received a combination of tele-monitoring and intensive follow-up and care through a call centre., Main Outcomes and Measures: Three primary endpoints were formulated: (1) composite of all-cause mortality, stroke, and myocardial infarction; (2) number of inpatient days; (3) the first plus cardiac decompensation, all measured at 12-months follow-up. Superiority was evaluated using a hierarchical multiple testing strategy for the 3 primary endpoints, where the first step is to test the second primary endpoint (hospitalization) at two-sided 5%-significance level. In case of a non-significant difference between the groups for the rate of hospitalization, the superiority of NICC over SoC is not shown., Results: The first primary endpoint occurred in 1.5% of NICC and 5.2% of SoC patients (OR: 3.3 [95%CI 1.4-8.3], p = 0.009). The number of inpatient treatment days did not differ significantly between both groups (p = 0.122). The third primary endpoint occurred in 3.6% of NICC and 8.1% of SoC patients (OR: 2.2 [95%CI 1.2-4.2], p = 0.016). Four patients died of all-cause death in the NICC and 23 in the SoC groups (OR: 4.4 [95%CI 1.6-12.6], p = 0.006). Based on the prespecified hierarchical statistical analysis protocol for multiple testing, the trial did not meet its primary outcome measure., Conclusions and Relevance: Among patients with atrial fibrillation, heart failure, or treatment-resistant hypertension, the NICC approach was not superior over SoC, despite a significant reduction in all-cause mortality, stroke, myocardial infarction and cardiac decompensation. Trial registration ClinicalTrials.gov Identifier: NCT03317951., (© 2023. The Author(s).)
- Published
- 2023
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