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Telemedicine for Patients With Chronic Respiratory Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00563745
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Michele Vitacca, Fondazione Salvatore Maugeri

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Respiratory Failure Device: telemedicine program Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Telemedicine
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CRF patients discharged from Respiratory Unit with home MV

Exclusion Criteria:

  • Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
  • Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
  • Being admitted to a nursing home
  • Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
  • Refusal to give informed consent
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
Telemedicine Service, Fondazione S. Maugeri, IRCCS
Lumezzane, Brescia, Italy, 25065
Sponsors and Collaborators
Michele Vitacca
Fondazione Salvatore Maugeri
Investigators
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Principal Investigator: Michele Vitacca, MD Fondazione S. Maugeri IRCCS
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Michele Vitacca, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT00563745    
Other Study ID Numbers: N°158
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Michele Vitacca, Fondazione Salvatore Maugeri:
COPD
ALS
Telemedicine
mechanical ventilation
Integrated care
strict follow up
 impact and costs on health care resources
telemedicine programme
home mechanical ventilation (HMV)
frail patients
chronic respiratory failure (CRF)
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases