Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure Clinical Trial
Official title:
RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care