Clinical Trials Directory

Trials / Completed

CompletedNCT00563745

Telemedicine for Patients With Chronic Respiratory Insufficiency

Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
240 (actual)
Sponsor
Michele Vitacca · Academic / Other
Sex
All
Age
12 Years – 85 Years
Healthy volunteers
Not accepted

Summary

In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM programme (supported by continuous availability of a call centre and a pulsed oxygen system) is cost/effective saving health care resources.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEtelemedicine programOne 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.

Timeline

Start date
2004-04-01
Primary completion
2005-04-01
Completion
2007-04-01
First posted
2007-11-26
Last updated
2015-03-06

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00563745. Inclusion in this directory is not an endorsement.