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
  Purpose

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 Intervention
Chronic Respiratory Failure
Other: telemedicine program
Device: telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • 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 ]

Enrollment: 240
Study Start Date: April 2004
Study Completion Date: April 2007
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemedicine
patients submitted to telemedicine program for 1 year
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
No Intervention: ARM 2 CONTROLS
Patients were not submitted to Telemedicine protocol
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563745

Locations
Italy
Telemedicine Service Fondazione Maugeri
Brescia, BS, Italy, 250666
Sponsors and Collaborators
Michele Vitacca
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Michele Vitacca, MD Fondazione S. Maugeri IRCCS
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michele Vitacca, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT00563745     History of Changes
Other Study ID Numbers: N°158
Study First Received: November 21, 2007
Last Updated: November 3, 2011
Health Authority: Italy: National Bioethics Committee

Keywords provided by 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:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014