Telemedicine for Patients With Chronic Respiratory Insufficiency
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|ClinicalTrials.gov Identifier: NCT00563745|
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Respiratory Failure||Device: telemedicine program||Not Applicable|
Background: Integrated care and strict follow up have been recommended for frail patients with chronic respiratory failure (CRF) discharged at home.
Objectives: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged at home with oxygen and/or home mechanical ventilation (HMV) with a high risk of hospital readmission.
Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S. Maugeri Foundation between May 2004 and March 2007.
Participants: 240 CRF patients will be randomised into an intervention group (TM) and a control Group, which received current usual care (educational plan, 3 months outpatient visits).
Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing.
Main outcome measures: survival, admissions to emergency room (ER), hospitalisations, urgent general practitioner (GP) calls, home relapses; probability to remain free from the above events will be also compared among groups. TM and health Care System costs as customer satisfaction will be also collected.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2007|
Patients were submitted to a Telemedicine program for 1 year
Device: telemedicine program
One year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing will be provided.
Other Name: home care
No Intervention: Control group
Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)
- To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. [ Time Frame: 3 years ]
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): NCT00563745
|Telemedicine Service, Fondazione S. Maugeri, IRCCS|
|Lumezzane, Brescia, Italy, 25065|
|Principal Investigator:||Michele Vitacca, MD||Fondazione S. Maugeri IRCCS|