Telemedicine for Patients With Chronic Respiratory Insufficiency

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00563745

Enrollment

240

Registered

2007-11-26

Start date

2004-04-30

Completion date

2007-04-30

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

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.

Interventions

DEVICEtelemedicine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026