Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580072
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : July 1, 2015
Last Update Posted : July 23, 2015
European Commission
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive (COPD) Other: self-monitoring for patients with severe COPD Other: nurse-monitoring for patients with severe COPD Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)
Study Start Date : February 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]
    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.

  2. Number of Inpatient Stays [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of Bed Days for Hospitalised Patients [ Time Frame: 12 months ]
  2. Number of Primary Care Visits [ Time Frame: 12 months ]
    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.

  3. Number of Specialist Visits [ Time Frame: 12 months ]
  4. Number of Consultations of Emergency Doctor [ Time Frame: 12 months ]
  5. All Cause Mortality [ Time Frame: 12 months ]
    deceased patients in respect to participating patients, by obituary column

  6. COPD Assessment Test CAT (Carinthia) [ Time Frame: 12 months ]
    No data available

  7. St. George's Respiratory Questionnaire SGRQ (Carinthia) [ Time Frame: 12 months ]

    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

  8. BODE Index (Carinthia) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01580072

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

Responsible Party: Landeskrankenanstalten-Betriebsgesellschaft Identifier: NCT01580072     History of Changes
Other Study ID Numbers: C250487
First Posted: April 18, 2012    Key Record Dates
Results First Posted: July 1, 2015
Last Update Posted: July 23, 2015
Last Verified: April 2015

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