Multiparametric Telemonitoring In Elderly People With Chronic Obstructive Pulmonary Disease (SweetAge)
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|ClinicalTrials.gov Identifier: NCT01481506|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Procedure: Telemonitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||June 2011|
Use of wearable sensors for heart rate, haemoglobin oxygen saturation, physical activity, respiratory rate with automatic transmission to the monitoring central.
|No Intervention: Usual care|
- Respiratory Events [ Time Frame: 9 months ]Rate of COPD 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. Rate of hospital admission for respiratory problems (COPD exacerbations, lower respiratory tract infections, respiratory failure).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481506
|Principal Investigator:||Raffaele Antonelli Incalzi, MD||Campus BioMedico University|