Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease - a randomized clinical trial

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.

Cost-effectiveness of a telemonitoring programme in patients with cardiovascular diseases compared with standard of care

“…The two composite endpoints as well as many secondary endpoints, such a mortality showed an advantage for NICC when compared with SoC. 7 However, the trial neither showed a significant difference in the number of hospitalisation days nor a significant difference in the number of hospitalisations between the two treatment groups. For patients in the NICC group, the treating physicians recommended, however, a visit to an established doctor or even a hospital in case patients had unusual telemonitoring findings or called the care centre.…”

“…11 The number of inpatient days in hospital were approximately 1.5 lower in the NICC group (CI 0.96 to 1.81). 7 Therefore, direct cost was expected to be lower in the NICC group compared with the SoC group. Indeed, direct cost was approximately €322.55 lower in the NICC group compared with the SoC group during the 1 year treatment period (CI €156.56 to €488.53; table 2 ).…”

“…Another limitation of this study is the short observation period for the randomised controlled trial. 7 The treatment and follow-up period in the trial was limited to 1 year per patient because the trial had to be completed within 3 years after its initiation. However, a long-term follow-up of all study patients is intended at 5 years after randomisation.…”

Cost-effectiveness of a telemonitoring program in patients with cardiovascular diseases compared to standard of care

“…Detailed assessments were at 6 months and 1 year after randomization. The CONSORT flowchart has been provided in (7). The primary diagnosis was AF, HF, and TRH in 265 (27.7%), 406 (42.4%), and 286 (29.9%) patients, respectively.…”

Shaping the Future of Cardiac Wellness: Exploring Revolutionary Approaches in Disease Management and Prevention

“…In addition to improving individual health outcomes, effective prevention and management of CVDs can also have broader societal benefits. By reducing the burden of CVDs, healthcare systems can allocate resources more efficiently and effectively, and the economic burden of CVDs can be reduced, leading to increased productivity and economic growth [7]. Recent years have seen significant advances in the prevention and management of CVDs.…”