Telemedicine for Patients With Chronic Respiratory Insufficiency
Primary Purpose
Chronic Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
telemedicine program
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Respiratory Failure focused on measuring 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)
Eligibility 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
Sites / Locations
- Telemedicine Service, Fondazione S. Maugeri, IRCCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telemedicine
Control group
Arm Description
Patients were submitted to a Telemedicine program for 1 year
Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00563745
First Posted
November 21, 2007
Last Updated
March 5, 2015
Sponsor
Michele Vitacca
Collaborators
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT00563745
Brief Title
Telemedicine for Patients With Chronic Respiratory Insufficiency
Official Title
Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michele Vitacca
Collaborators
Fondazione Salvatore Maugeri
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure
Keywords
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)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Patients were submitted to a Telemedicine program for 1 year
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)
Intervention Type
Device
Intervention Name(s)
telemedicine program
Other Intervention Name(s)
home care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Vitacca, MD
Organizational Affiliation
Fondazione S. Maugeri IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Telemedicine Service, Fondazione S. Maugeri, IRCCS
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25065
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16611656
Citation
Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
Results Reference
background
PubMed Identifier
17389286
Citation
Adams SG, Smith PK, Allan PF, Anzueto A, Pugh JA, Cornell JE. Systematic review of the chronic care model in chronic obstructive pulmonary disease prevention and management. Arch Intern Med. 2007 Mar 26;167(6):551-61. doi: 10.1001/archinte.167.6.551.
Results Reference
background
PubMed Identifier
18799512
Citation
Vitacca M, Bianchi L, Guerra A, Fracchia C, Spanevello A, Balbi B, Scalvini S. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. Eur Respir J. 2009 Feb;33(2):411-8. doi: 10.1183/09031936.00005608. Epub 2008 Sep 17.
Results Reference
result
PubMed Identifier
33511633
Citation
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Results Reference
derived
Links:
URL
http://www.fsm.it
Description
istitutional web site
URL
http://www.telemed.org
Description
telemedicine site
URL
http://www.ehtel.org
Description
european telemedicine site
Learn more about this trial
Telemedicine for Patients With Chronic Respiratory Insufficiency
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