Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. The investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.
All patients performed a simple spirometry that was carried out using a Stead-Wells bell
spirometer (Biomedin, Padua, Italy). Upon provision of informed consent, patients in the
telemonitoring group were invited to a session during which they were instructed on how to
wear the wristband and to operate the cellular telephone. A study physician was available on
call during office hours to assist patients needing further instructions. A technician was
also available in order to solve ingoing hardware problems.
All participants were also clinically evaluated at baseline and received a multi-dimensional
assessment including: Activities of daily living scale (ADL), Instrumental activities of
daily living scale (IADL), Mini-mental state examination (MMSE) test. These are well
validated and routinely used tools to screen geriatric patients in order to detect global,
physical and instrumental autonomy and consequent degree of dependence, as well as cognitive
status.
Patients in both groups were followed up for 9 months, during this period they attended the
standard schedule of clinical controls. For patients in the SweetAge group, the parameters
received were evaluated daily by a study physician. In case of abnormal readings, the
physician systematically contacted the patient to verify whether their symptoms had worsened
or new symptoms had arose. In this event, the patient's adherence to her/his therapy was
checked and, if unsatisfactory, individually tailored interventions promoting adherence were
carried up. Otherwise, a diagnosis of exacerbation was made and, on the basis of its
severity, an outpatient clinical assessment (for mild exacerbations) or a hospital admission
was scheduled.
The outcome measures of these study were: number of exacerbations (defined as a sustained
worsening of the patient's condition, from the stable state and beyond normal day-to-day
variations, that is acute in onset and necessitates a change in regular medications, and
number of hospital admissions.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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