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NCT00563745 Clinical Trial

Telemedicine for Patients With Chronic Respiratory Insufficiency

Chronic Respiratory Failure Clinical Trial

Official title:
Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00563745
Other study ID # N°158
Secondary ID
Status Completed
Phase N/A
First received November 21, 2007
Last updated March 5, 2015
Start date April 2004
Est. completion date April 2007

Study information
Verified date March 2015
Source Fondazione Salvatore Maugeri
Contact n/a
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date April 2007
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Italy Telemedicine Service, Fondazione S. Maugeri, IRCCS Lumezzane Brescia

Sponsors (2)
Lead Sponsor Collaborator
Michele Vitacca Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View Citation

Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernández C, Alonso A, del Pozo F, de Toledo P, Antó JM, Rodríguez-Roisín 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. Epub 2006 Apr 12. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 years No
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