The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. In addition, the trial evaluates the economic and organisational impact of the telemonitoring service and examines its acceptability by patients and health professionals.
The study is designed to evaluate the impact of telemonitoring on the follow-up of elderly patients with one or more chronic diseases among heart failure, chronic obstructive pulmonary disease and diabetes. The particular target of patients selected has the particularity of being "frail" according to a set of social eligibility criteria, agreed by the clinicians participating at the study. General practitioners are the first clinicians in charge of managing these patients during the trial follow-up. The term of comparison is represented by a control group, followed by outpatient usual care. From a clinical point of view, the trial will investigate how the remote monitoring of some clinical parameters contributes to reduce the access to healthcare facilities (emergency and planned hospitalization, bed-days, ER, specialist and GP visits), to improve the patients health-related quality of life and to reduce the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
152
Patients are equipped with a telemonitoring kit that can be composed by a portable wrist clinic device, a digital weight scale and a glucometer for clinical parameters measuring, according to the pathologies of the patient. The equipment is completed by a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG, body weight and glycemia with a frequency set by the clinician in the personalized treatment plan. In the same protocol the clinician includes also the alarm thresholds that determine when the clinical measures are out-of-range. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the general practitioner in case of worsening of symptoms.
Local Heath Authority of Padova
Padua, Padova, Italy
Local Health Authority of Pieve di Soligo
Pieve di Soligo, Treviso, Italy
Local Health Authority of Treviso
Treviso, Treviso, Italy
Local Health Authority of Mirano
Mirano, Venezia, Italy
Number of emergency hospitalisations
Time frame: 12 months
Number of primary care visits.
Time frame: 12 months
Health related quality of life as measured by the SF 36 version 2 questionnaire
Time frame: 12 months
All cause mortality
Time frame: 12 months
Number of visits to emergency department
Time frame: 12 months
Number of elective hospital admissions
Time frame: 12 months
Number of bed days for hospitalised patients
Time frame: 12 months
Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.
Time frame: 12 months
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Local Heath Authority Veneziana
Venezia, Venezia, Italy
Local Heath Authority of Verona
Verona, Verona, Italy
Local Heath Authority of Thiene
Thiene, Vicenza, Italy