Telemedicine for Patients With Chronic Respiratory Insufficiency
NCT ID: NCT00563745
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2004-04-30
2007-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Telemedicine
Patients were submitted to a Telemedicine program for 1 year
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.
Control group
Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
12 Years
85 Years
ALL
No
Sponsors
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Fondazione Salvatore Maugeri
OTHER
Michele Vitacca
OTHER
Responsible Party
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Michele Vitacca
Fondazione Salvatore Maugeri
Principal Investigators
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Michele Vitacca, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione S. Maugeri IRCCS
Locations
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Telemedicine Service, Fondazione S. Maugeri, IRCCS
Lumezzane, Brescia, Italy
Countries
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References
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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.
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.
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.
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.
Related Links
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istitutional web site
telemedicine site
european telemedicine site
Other Identifiers
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N°158
Identifier Type: -
Identifier Source: org_study_id
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