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Telemedicine for Patients With Chronic Respiratory Insufficiency

This study has been completed.
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Michele Vitacca, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00563745
First received: November 21, 2007
Last updated: November 3, 2011
Last verified: November 2011

November 21, 2007
November 3, 2011
April 2004
April 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00563745 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Telemedicine for Patients With Chronic Respiratory Insufficiency
Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.

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.

Background: Integrated care and strict follow up have been recommended for frail patients discharged with chronic respiratory failure (CRF).

Objectives: 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.

Design: Prospective randomised controlled trial. Setting: Respiratory Unit S. Maugeri Foundation between May 2004 and March 2007.

Participants: 240 CRF patients were 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 were also compared among groups. TM and health Care System costs as customer satisfaction were also collected.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Respiratory Failure
  • Other: 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.
    Other Name: home care
  • Device: telemedicine
    telemedicine prescription
    Other Name: home care
  • Experimental: Telemedicine
    patients submitted to telemedicine program for 1 year
    Interventions:
    • Other: telemedicine program
    • Device: telemedicine
  • No Intervention: ARM 2 CONTROLS
    Patients were not submitted to Telemedicine protocol
    Interventions:
    • Other: telemedicine program
    • Device: telemedicine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
April 2007
April 2005   (final data collection date for primary outcome measure)

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
Both
12 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00563745
N°158
No
Michele Vitacca, Fondazione Salvatore Maugeri
Michele Vitacca
Fondazione Salvatore Maugeri
Principal Investigator: Michele Vitacca, MD Fondazione S. Maugeri IRCCS
Fondazione Salvatore Maugeri
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP