Multiparametric Telemonitoring In Elderly People With Chronic Obstructive Pulmonary Disease
SweetAge
Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease
Started Jan 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 8, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedNovember 29, 2011
November 1, 2011
1 year
November 8, 2011
November 28, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Telemonitoring
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
Use of wearable sensors for heart rate, haemoglobin oxygen saturation, physical activity, respiratory rate with automatic transmission to the monitoring central.
Eligibility Criteria
You may qualify if:
- Patients with chronic obstructive pulmonary disease stage II-III (GOLD classification)
You may not qualify if:
- Cognitive impairment precluding the use of the experimental device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pedone C, Chiurco D, Scarlata S, Incalzi RA. Efficacy of multiparametric telemonitoring on respiratory outcomes in elderly people with COPD: a randomized controlled trial. BMC Health Serv Res. 2013 Mar 6;13:82. doi: 10.1186/1472-6963-13-82.
PMID: 23497109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raffaele Antonelli Incalzi, MD
Campus BioMedico University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Unit of Geriatrics.
Study Record Dates
First Submitted
November 8, 2011
First Posted
November 29, 2011
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
June 1, 2011
Last Updated
November 29, 2011
Record last verified: 2011-11