Telemedicine for Patients With Chronic Respiratory Insufficiency

Sponsor

Michele Vitacca (Other)

Overall Status

Completed

CT.gov ID

NCT00563745

Collaborator

Fondazione Salvatore Maugeri (Other)

240

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Respiratory Failure	Device: telemedicine program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemedicine Patients were submitted to a Telemedicine program for 1 year	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. Other Names: home care
No Intervention: Control group Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)

Arm

Intervention/Treatment

Experimental: Telemedicine

Patients were submitted to a Telemedicine program for 1 year

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.

Other Names:

home care

No Intervention: Control group

Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)

Outcome Measures

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. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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