A multi-country randomised trial of the role of a new telemonitoring system in CHF: The HHH study (Home or Hospital in Heart Failure). Rational, study design and protocol
Mortara A., Pinna GD., Johnson P., Dargie H., La Rovere MT., Ponikowski P., Tavazzi L., Sleight P.
The HHH study will be a full scale randomized controlled trial in Italy, Poland and UK enrolling 450 CHF patients (LVEF < 40%, NYHA cl. II-IV) in 2 arms (usual clinical practice and home-care strategy). Objectives will be: (1) to determine if different strategies of home-care telemonitoring, affect hospital admissions, improve patient sense of well-being, and reduce overall costs of medical care; (2) to define the prevalence and the clinical impact of breathing disorders, arrhythmias and abnormalities of HRV in the occurrence of acute periods of instability and when on optimal therapy; (3) to evaluate in the home setting a new system for continuous monitoring of cardio-respiratory signals plus physical activity with teletransmission of recorded data embedded in an interactive voice response based telehealth system. The 300 'home strategy' patients will be divided into: (1) normal clinical practice supplemented by telephone contacts; (2) as strategy 1 plus periodic telemonitoring of vital signs parameters; (3) as 2deg; strategy plus periodic 24 h ECG, respiration and physical activity (NICRAM) recording. Enrolment will be over 12 months with a further 12 months follow-up. The primary end-point will be total bed-days occupancy for heart failure in acute medical/surgical beds. The first patient was enrolled in September 2002. The trial is expected to be completed at the middle of 2005. © 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.