Telemonitoring of Patients With COPD in Carinthia

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
• Interventions: Other: self-monitoring for patients with severe COPD; Other: nurse-monitoring for patients with severe COPD

• Registration Number: NCT01580072
• Lead Sponsor: Landeskrankenanstalten-Betriebsgesellschaft

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2013-07
• Study Completion: 2014-02
• Status Verified: 2015-04
• Results First Submitted: 2015-04-08
• Results First Submitted QC: 2015-06-25
• Results First Posted: 2015-07-01
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self monitoring for patients with COPD	self-monitoring for patients with severe COPD	-
Nurse monitoring for patients with COPD	nurse-monitoring for patients with severe COPD	-

Primary Outcome Measures

Name	Time	Method
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.	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.
Number of Inpatient Stays	12 months

Secondary Outcome Measures

Name	Time	Method
COPD Assessment Test CAT (Carinthia)	12 months	No data available
Number of Bed Days for Hospitalised Patients	12 months
All Cause Mortality	12 months	deceased patients in respect to participating patients, by obituary column
Number of Primary Care Visits	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.
Number of Specialist Visits	12 months
Number of Consultations of Emergency Doctor	12 months
St. George's Respiratory Questionnaire SGRQ (Carinthia)	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
BODE Index (Carinthia)	12 months

Trial Locations

Locations (3)

LKH Laas; 🇦🇹 Kötschach, Carintha, Austria

Klinikum Klagenfurt; 🇦🇹 Klagenfurt, Carinthia, Austria

LKH Villach; 🇦🇹 Villach, Carinthia, Austria