Ines Frederix1,2,3, Lien Vanderlinden4, Anne-Sophie Verboven5, Maria Welten3, Donna Wouters5, Gilles De Keulenaer6, Bavo Ector7, Ivan Elegeert8, Pierre Troisfontaines9, Caroline Weytjens10, Wilfried Mullens11, Paul Dendale1,2. 1. 1 Faculty of Medicine and Life Sciences, Hasselt University, Belgium. 2. 2 Department of Cardiology, Jessa Hospital, Belgium. 3. 3 Faculty of Medicine and Health Sciences, Antwerp University, Belgium. 4. 4 Faculty of Medicine, KU Leuven, Belgium. 5. 5 Faculty of Medicine and Health Sciences, Ghent University, Belgium. 6. 6 Department of Cardiology, Middelheim Hospital, Belgium. 7. 7 Department of Cardiology, Imelda Hospital, Belgium. 8. 8 Department of Cardiology, Groeninge Hospital, Belgium. 9. 9 Department of Cardiology, CHR Citadelle, Belgium. 10. 10 Department of Cardiology, UZ Brussels, Belgium. 11. 11 Department of Cardiology, East Limburg Hospital, Belgium.
Abstract
AIMS: The TElemonitoring in the MAnagement of Heart Failure (TEMA-HF) 1 long-term follow-up study assessed whether an initial six-month telemonitoring (TM) programme compared with usual care (UC) would result in reduced all-cause mortality, heart failure admissions and healthcare costs in chronic heart failure (CHF) patients at long-term follow-up. METHODS: Of the 160 patients included in the multi-centre, randomised controlled telemonitoring trial (TEMA-HF 1, time point t0); 142 CHF patients (65% male; age: 76 ± 10 years; EF: 36 ± 15%) were alive and entered the follow-up study (time point: t1) with a final evaluation at 79 months (time point: t2). Both TM and UC group patients received standard heart failure care during the follow-up study (time points: t1 - t2). The primary endpoint was all-cause mortality. Secondary outcomes included days lost due to heart failure readmissions and readmission/patient follow-up related healthcare costs. RESULTS: Compared with usual care, the initial six-month TM programme had no significant effect on all-cause mortality (hazard ratio: 0.83; 95% confidence interval, 0.57 to 1.20; p = 0.32). The number of days lost due to heart failure readmissions was significantly lower in the TM group ( p = 0.04). Healthcare costs did not differ significantly between the TM (€ 9140 ± 10580) and UC group (€ 12495 ± 22433) ( p = 0.87). DISCUSSION: An initial six-month telemonitoring programme was not associated with reduced all-cause mortality in CHF patients at long-term follow-up but resulted in a reduction in the number of days lost due to heart failure readmissions. This study is registered in the ClinicalTrials.gov registry (NCT03171038) (URL: https://clinicaltrials.gov/ct2/show/NCT03171038 ).
RCT Entities:
AIMS: The TElemonitoring in the MAnagement of Heart Failure (TEMA-HF) 1 long-term follow-up study assessed whether an initial six-month telemonitoring (TM) programme compared with usual care (UC) would result in reduced all-cause mortality, heart failure admissions and healthcare costs in chronic heart failure (CHF) patients at long-term follow-up. METHODS: Of the 160 patients included in the multi-centre, randomised controlled telemonitoring trial (TEMA-HF 1, time point t0); 142 CHFpatients (65% male; age: 76 ± 10 years; EF: 36 ± 15%) were alive and entered the follow-up study (time point: t1) with a final evaluation at 79 months (time point: t2). Both TM and UC group patients received standard heart failure care during the follow-up study (time points: t1 - t2). The primary endpoint was all-cause mortality. Secondary outcomes included days lost due to heart failure readmissions and readmission/patient follow-up related healthcare costs. RESULTS: Compared with usual care, the initial six-month TM programme had no significant effect on all-cause mortality (hazard ratio: 0.83; 95% confidence interval, 0.57 to 1.20; p = 0.32). The number of days lost due to heart failure readmissions was significantly lower in the TM group ( p = 0.04). Healthcare costs did not differ significantly between the TM (€ 9140 ± 10580) and UC group (€ 12495 ± 22433) ( p = 0.87). DISCUSSION: An initial six-month telemonitoring programme was not associated with reduced all-cause mortality in CHFpatients at long-term follow-up but resulted in a reduction in the number of days lost due to heart failure readmissions. This study is registered in the ClinicalTrials.gov registry (NCT03171038) (URL: https://clinicaltrials.gov/ct2/show/NCT03171038 ).
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