Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)

REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
• Intervention / Treatment: Other: self-monitoring for patients with severe COPD; Other: nurse-monitoring for patients with severe COPD

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Carintha
    • Kötschach, Carintha, Austria, 9640
      • LKH Laas
  • Carinthia
    • Klagenfurt, Carinthia, Austria, 9020
      • Klinikum Klagenfurt
    • Villach, Carinthia, Austria, 9500
      • LKH Villach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Number of Inpatient Stays		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Bed Days for Hospitalised Patients		12 months
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.	12 months
Number of Specialist Visits		12 months
Number of Consultations of Emergency Doctor		12 months
All Cause Mortality	deceased patients in respect to participating patients, by obituary column	12 months
COPD Assessment Test CAT (Carinthia)	No data available	12 months
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	12 months
BODE Index (Carinthia)		12 months

Collaborators and Investigators

• Sponsor: Landeskrankenanstalten-Betriebsgesellschaft
• Collaborators: European Commission

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 18, 2012

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: C250487