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Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)

Primary Purpose

Pulmonary Disease, Chronic Obstructive (COPD)

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
self-monitoring for patients with severe COPD
nurse-monitoring for patients with severe COPD
Sponsored by
Landeskrankenanstalten-Betriebsgesellschaft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive (COPD)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

  • LKH Laas
  • Klinikum Klagenfurt
  • LKH Villach

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Self monitoring for patients with COPD

Nurse monitoring for patients with COPD

Arm Description

Participants in the control group receive usual care.

Outcomes

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.
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

Secondary Outcome Measures

Number of Bed Days for Hospitalised Patients
Number of Primary Care Visits
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
Number of Consultations of Emergency Doctor
All Cause Mortality
deceased patients in respect to participating patients, by obituary column
COPD Assessment Test CAT (Carinthia)
No data available
St. George's Respiratory Questionnaire SGRQ (Carinthia)
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)

Full Information

First Posted
April 17, 2012
Last Updated
July 1, 2015
Sponsor
Landeskrankenanstalten-Betriebsgesellschaft
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01580072
Brief Title
Telemonitoring of Patients With COPD in Carinthia
Acronym
RenewingHealth
Official Title
REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landeskrankenanstalten-Betriebsgesellschaft
Collaborators
European Commission

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive (COPD)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group receive usual care.
Arm Title
Self monitoring for patients with COPD
Arm Type
Experimental
Arm Title
Nurse monitoring for patients with COPD
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
self-monitoring for patients with severe COPD
Intervention Description
Intervention Group entering vital parameters via Web Portal or automatic call center.
Intervention Type
Other
Intervention Name(s)
nurse-monitoring for patients with severe COPD
Intervention Description
Nurses are entering vital parameters of the patient with mobile devices.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months
Title
Number of Inpatient Stays
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Bed Days for Hospitalised Patients
Time Frame
12 months
Title
Number of Primary Care Visits
Description
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.
Time Frame
12 months
Title
Number of Specialist Visits
Time Frame
12 months
Title
Number of Consultations of Emergency Doctor
Time Frame
12 months
Title
All Cause Mortality
Description
deceased patients in respect to participating patients, by obituary column
Time Frame
12 months
Title
COPD Assessment Test CAT (Carinthia)
Description
No data available
Time Frame
12 months
Title
St. George's Respiratory Questionnaire SGRQ (Carinthia)
Description
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
Time Frame
12 months
Title
BODE Index (Carinthia)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD 3 or 4 Be able to use the system provided Life expectancy > 12 months Exclusion Criteria:
Facility Information:
Facility Name
LKH Laas
City
Kötschach
State/Province
Carintha
ZIP/Postal Code
9640
Country
Austria
Facility Name
Klinikum Klagenfurt
City
Klagenfurt
State/Province
Carinthia
ZIP/Postal Code
9020
Country
Austria
Facility Name
LKH Villach
City
Villach
State/Province
Carinthia
ZIP/Postal Code
9500
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Telemonitoring of Patients With COPD in Carinthia

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