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.


OBJECTIVE
This paper outlines the study protocol of a tailor-made telemonitoring program in ambulant patients with HF.


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.
Boyne
Josiane J J
JJ
Maastricht University Medical Centre, Maastricht University, The Netherlands. j.boyne@zw.unimaas.nl
Vrijhoef
Hubertus J M
HJ
Wit
R de
Rd
Gorgels
Anton P M
AP
D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D019468:Disease Management; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D015999:Multivariate Analysis; D009426:Netherlands / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D010343:Patient Admission / Q000706:statistics & numerical data; D010347:Patient Care Planning / Q000458:organization & administration*; D010349:Patient Compliance; D010353:Patient Education as Topic / Q000458:organization & administration*; D015397:Program Evaluation; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D012648:Self Care; D017216:Telemedicine / Q000295:instrumentation / Q000458:organization & administration*; D013813:Therapy, Computer-Assisted / Q000458:organization & administration*