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OpenTrials
Completed

NCT Number: NCT00563745

Telemedicine for Patients With Chronic Respiratory Insufficiency

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.

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Key information

Conditions

Chronic Respiratory Failure Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

12 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Telemedicine Service, Fondazione S. Maugeri, IRCCS

Lumezzane, Brescia, 25065, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telemedicine program

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Michele Vitacca

Other

Collaborators

  • Fondazione Salvatore Maugeri

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Nov 26, 2007
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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