The First Year of Noninvasive Remote Telemonitoring in Chronic Heart Failure Is not Cost Saving but Improves Quality of Life: The Randomized Controlled CardioBBEAT Trial

Abstract

Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva ® ) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany. Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 ± 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in k€) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life. Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 ± 59 days, SoC 346 ± 45 days; p = 0.298) associated with increased total costs (RTM 18.5 ± 39.5 k€, SoC 12.8 ± 22.0 k€; p = 0.046). This yielded an ICER of −1.15 k€/day. RTM did not impact mortality risk. All quality of life scales were consistently and meaningfully improved in the RTM group at 12 months compared to SoC (all p < 0.01). Conclusions: The first 12 months of RTM were not cost-effective compared to SoC in patients with HFrEF, but associated with a relevant improvement in disease-specific quality of life. The balanced assessment of the potential benefit of RTM requires integration of both the societal and patient perspective. (NCT02293252).

Economic Evaluations of Digital Health Interventions for Patients With Heart Failure: Systematic Review

“…Table 1 summarizes the general characteristics of the included studies. Of the 27 studies, 13 (48%) were conducted using a decision analytical model [ 31 - 35 , 40 , 47 - 51 ], 13 (48%) used trial-based data [ 36 - 39 , 41 - 46 , 54 - 57 ], and 1 (4%) used a combination of both [ 41 ]. The majority of the studies (25/27, 93%) were from HICs.…”

“…The majority of the studies (25/27, 93%) were from HICs. Of the 27 studies, 6 (22%) were from the United States [ 34 , 43 , 44 , 51 - 53 ]; 3 (11%) each from the Netherlands [ 33 , 37 , 40 ] and the United Kingdom [ 32 , 35 , 50 ]; 2 (7%) each from Germany [ 36 , 38 ], Brazil [ 41 , 45 ], Canada [ 42 , 48 ], Italy [ 55 , 56 ], and Spain [ 46 , 49 ]; and 1 (4%) each from Australia [ 57 ], Poland [ 54 ], France [ 31 ], Hong Kong [ 47 ], and Denmark [ 39 ]. Of the 27 studies, 24 (89%) conducted a cost-utility analysis with cost and QALY as the outcome measures [ 31 - 35 , 37 - 40 , 42 - 51 , 54 , 56 , 57 ], 2 (7%) conducted a cost-effectiveness analysis (1/2, 50% with hospital readmission as the outcome measure [ 41 ] and 1/2, 50% with number of days alive and neither in hospital nor in inpatient care as the outcome measure [ 36 ]), and 1 (3%) conducted a cost-minimization analysis [ 55 ].…”

Effect of e-health intervention on disease management in patients with chronic heart failure: A meta-analysis

“…Twelve ( 9 , 11 – 14 , 16 , 20 – 24 , 26 ) studies involving a total of 4,059 patients assessed all-cause mortality. Due to the high homogeneity of the included studies ( I 2 = 0%, P = 0.46), the fixed effect model was used.…”

“…Eight ( 8 , 13 , 14 , 16 , 20 , 21 , 25 , 26 ) studies involving 2279 patients reported findings on all-cause hospitalization rate. Due to the high heterogeneity, the random effects model was used in this study ( I 2 = 67.5%, P = 0.00).…”

“…Six ( 12 , 13 , 16 , 20 , 22 , 26 ) studies involving 3,635 patients reported findings of heart failure-related hospitalization rate. Statistical heterogeneity was not present in these studies and therefore fixed effects model were used ( I 2 = 0.0%, P = 0.47).…”