Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)

This study has been completed.
European Commission
Information provided by (Responsible Party):
Landeskrankenanstalten-Betriebsgesellschaft Identifier:
First received: April 17, 2012
Last updated: July 1, 2015
Last verified: April 2015
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)

Further study details as provided by Landeskrankenanstalten-Betriebsgesellschaft:

Primary Outcome Measures:
  • Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered.

  • Number of Inpatient Stays [ 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 ]
    Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.

  • Number of Specialist Visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Consultations of Emergency Doctor [ 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 ]
    No data available

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

    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.

    Scores are calculated for three domains:

    Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.

    A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos

  • BODE Index (Carinthia) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: February 2010
Study Completion Date: February 2014
Primary Completion Date: July 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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01580072

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

No publications provided

Responsible Party: Landeskrankenanstalten-Betriebsgesellschaft Identifier: NCT01580072     History of Changes
Other Study ID Numbers: C250487
Study First Received: April 17, 2012
Results First Received: April 8, 2015
Last Updated: July 1, 2015
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases processed this record on November 27, 2015