Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study

BACKGROUND: Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient's home. The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions. METHODS/DESIGN: A primary care-based randomised controlled trial will be carried out to assess the impact of a telemonitoring intervention aimed at home care patients with heart failure (HF) and/or chronic lung disease (CLD). The results will be compared with those obtained with standard health care practice. The duration of the study will be of one year. Sixty patients will be recruited for the study. In-home patients, diagnosed with HF and/or CLD, aged 14 or above and with two or more hospital admissions in the previous year will be eligible. For the intervention group, telemonitoring will consist of daily patient self-measurements of respiratory-rate, heart-rate, blood pressure, oxygen saturation, weight and body temperature. Additionally, the patients will complete a qualitative symptom questionnaire daily using the telemonitoring system. Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits. The control group will receive usual care. The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-randomisation. The secondary outcome measures are: duration of hospital stay, hospital admissions due to HF or CLD, mortality rate, use of health care resources, quality of life, cost-effectiveness, compliance and patient and health care professional satisfaction with the new technology. DISCUSSION: The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting. The study may contribute to enhance the understanding of alternative modes of health care provision for medically unstable elderly patients, who bear a high degree of physical and functional deterioration. TRIAL REGISTRATION: ISRCTN: ISRCTN89041993