Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial

Background: As the prevalence of heart failure (HF) rises sharply, the costs related to the care of these patients increases in parallel. Considering the already limited resources and manpower, in the future the demand for care may exceed the supply. Therefore, health care systems are encouraged to develop innovative strategies to deal with the burden of HF to improve the quality of care in order to medical outcomes and patients' quality of life. For that reason new management systems - such as telemonitoring - have to be explored. Objectives: This paper outlines the study protocol of a tailor-made telemonitoring program in ambulant patients with HF. Design and methods: A prospective randomised controlled trial is carried out at 3 hospitals in the South-Limburg area in the Netherlands. Primary outcome measures are hospital admissions and cost-effectiveness. Secondary outcomes are effects on therapy compliance, level of disease specific knowledge and quality of life. Also determinants are studied of most and less benefited patients in the intervention group. Power calculation: It is estimated that 390 patients have to be included in the study, with 185 in each arm. Results: Inclusion started in September 2007 with a follow-up time of 12 months. First results are expected at the end of 2010.