Adding telemonitoring to an ICT-guided disease management system did not significantly improve the composite endpoint of mortality, heart failure readmission, and quality of life in patients with worsening heart failure.
RCT (n=177)
Open-label with blinded endpoint adjudication
Computer-generated random permuted blocks stratified by center
Sí
Does adding telemonitoring to an ICT-guided disease management system improve a composite of mortality, HF-readmission, and HR-QoL in chronic heart failure patients?
Adding telemonitoring to an ICT-guided disease management system in heart failure patients did not improve the composite of mortality, readmission, and quality of life, but significantly reduced HF-outpatient clinic visits.
Mean Difference: 0.1 (95% CI -0.67–0.82)
Tasa de eventos absoluta: -0.73% vs -0.63%
valor p: p=0.39
AIM: It is still unclear whether telemonitoring reduces hospitalization and mortality in heart failure (HF) patients and whether adding an Information and Computing Technology-guided-disease-management-system (ICT-guided-DMS) improves clinical and patient reported outcomes or reduces healthcare costs. METHODS: A multicenter randomized controlled trial was performed testing the effects of INnovative ICT-guided-DMS combined with Telemonitoring in OUtpatient clinics for Chronic HF patients (IN TOUCH) with in total 179 patients (mean age 69 years; 72% male; 77% in New York Heart Association Classification (NYHA) III-IV; mean left ventricular ejection fraction was 28%). Patients were randomized to ICT-guided-DMS or to ICT-guided-DMS+telemonitoring with a follow-up of nine months. The composite endpoint included mortality, HF-readmission and change in health-related quality of life (HR-QoL). RESULTS: In total 177 patients were eligible for analyses. The mean score of the primary composite endpoint was -0.63 in ICT-guided-DMS vs. -0.73 in ICT-guided-DMS+telemonitoring (mean difference 0.1, 95% CI: -0.67 +0.82, p=0.39). All-cause mortality in ICT-guided-DMS was 12% versus 15% in ICT-guided-DMS+telemonitoring (p=0.27); HF-readmission 28% vs. 27% p=0.87; all-cause readmission was 49% vs. 51% (p=0.78). HR-QoL improved in most patients and was equal in both groups. Incremental costs were €1360 in favor of ICT-guided-DMS. ICT-guided-DMS+telemonitoring had significantly fewer HF-outpatient-clinic visits (p<0.01). CONCLUSION: ICT-guided-DMS+telemonitoring for the management of HF patients did not affect the primary and secondary endpoints. However, we did find a reduction in visits to the HF-outpatient clinic in this group suggesting that telemonitoring might be safe to use in reorganizing HF-care with relatively low costs.
Kraai et al. (Sun,) realizaron un ECA en insuficiencia cardíaca (n=177). Se evaluó un sistema de gestión de enfermedades guiado por ICT con telemonitoreo vs. sistema de gestión de enfermedades guiado por ICT solo en un puntaje compuesto ponderado de mortalidad, reingreso por IC y cambio en la CVRS (MD 0.1, 95% CI -0.67 a 0.82, p=0.39). Agregar telemonitoreo a un sistema de gestión de enfermedades guiado por ICT no mejoró significativamente el punto final compuesto de mortalidad, reingreso por insuficiencia cardíaca y calidad de vida en pacientes con insuficiencia cardíaca en deterioro.