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Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Landeskrankenanstalten-Betriebsgesellschaft
ClinicalTrials.gov Identifier:
NCT01580072
First received: April 17, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

Evaluation whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of reduced hospital readmissions, improved health related quality of life and health status. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Condition Intervention
Pulmonary Disease, Chronic Obstructive (COPD)
 Other: self-monitoring for patients with severe COPD
Other: nurse-monitoring for patients with severe COPD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Landeskrankenanstalten-Betriebsgesellschaft:

Primary Outcome Measures:
  • Health related quality of life as measured by the SF 36 version 2 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of hospitalisations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of bed days for hospitalised patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of primary care visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of specialist visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of visits at emergency department [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    deceased patients in respect to participating patients, by obituary column

  • COPD assessment test CAT (Carinthia) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire SGRQ (Carinthia) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BODE index (Carinthia) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: February 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Participants in the control group receive usual care.
Experimental: Self monitoring for patients with COPD Other: self-monitoring for patients with severe COPD
Intervention Group entering vital parameters via Web Portal or automatic call center.
Experimental: Nurse monitoring for patients with COPD Other: nurse-monitoring for patients with severe COPD
Nurses are entering vital parameters of the patient with mobile devices.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD 3 or 4
  • Be able to use the system provided
  • Life expectancy > 12 months

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580072

Locations
Austria
LKH Laas
Kötschach, Carintha, Austria, 9640
Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria, 9020
LKH Villach
Villach, Carinthia, Austria, 9500
Sponsors and Collaborators
Landeskrankenanstalten-Betriebsgesellschaft
European Commission
  More Information

No publications provided

Responsible Party: Landeskrankenanstalten-Betriebsgesellschaft
ClinicalTrials.gov Identifier: NCT01580072     History of Changes
Other Study ID Numbers: C250487
Study First Received: April 17, 2012
Last Updated: August 14, 2012
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 21, 2013