Telemedicine for Patients With Chronic Respiratory Insufficiency
|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 ]
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|