Chronic Obstructive Pulmonary Disease Clinical Trial
— SweetAgeOfficial title:
Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
Verified date | November 2011 |
Source | Campus Bio-Medico University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Patients with chronic obstructive pulmonary disease stage II-III (GOLD classification) Exclusion Criteria: - Cognitive impairment precluding the use of the experimental device. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory Events | 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). | 9 months | No |
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