NCT00563745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

November 21, 2007

Last Update Submit

March 5, 2015

Conditions

Chronic Respiratory Failure

Keywords

COPDALSTelemedicinemechanical ventilationIntegrated carestrict follow upimpact and costs on health care resourcestelemedicine programmehome mechanical ventilation (HMV)frail patientschronic respiratory failure (CRF)

Outcome Measures

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.

    3 years

Study Arms (2)

Telemedicine

EXPERIMENTAL

Patients were submitted to a Telemedicine program for 1 year

Device: telemedicine program

Control group

NO INTERVENTION

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

Interventions

telemedicine programDEVICE

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.

Also known as: home care
Telemedicine

Eligibility Criteria

Age12 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • CRF patients discharged from Respiratory Unit with home MV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Telemedicine Service, Fondazione S. Maugeri, IRCCS

Lumezzane, Brescia, 25065, Italy

Location

Related Publications (4)

  • 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.

    PMID: 16611656BACKGROUND

  • 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.

    PMID: 17389286BACKGROUND

  • 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.

    PMID: 18799512RESULT

  • 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.

    PMID: 33511633DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveTooth, Impacted

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic Diseases

Study Officials

  • Michele Vitacca, MD

    Fondazione S. Maugeri IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fondazione Salvatore Maugeri

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

April 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2007

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

IT(1)