Telemonitoring of Patients With COPD in Carinthia

NCT01580072 | Completed Results

• 1 other identifier: C250487
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Number of Bed Days for Hospitalised Patients

  12 months

• Number of Primary Care Visits

  12 months

• Number of Specialist Visits

  12 months

• Number of Consultations of Emergency Doctor

  12 months

• All Cause Mortality

  12 months

Study Arms (3)

Control group

NO INTERVENTION

Participants in the control group receive usual care.

Self monitoring for patients with COPD

EXPERIMENTAL

Other: self-monitoring for patients with severe COPD

Nurse monitoring for patients with COPD

EXPERIMENTAL

Other: nurse-monitoring for patients with severe COPD

Interventions

self-monitoring for patients with severe COPD OTHER

Intervention Group entering vital parameters via Web Portal or automatic call center.

Self monitoring for patients with COPD

nurse-monitoring for patients with severe COPD OTHER

Nurses are entering vital parameters of the patient with mobile devices.

Nurse monitoring for patients with COPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Landeskrankenanstalten-Betriebsgesellschaft: lead
• European Commission: collaborator

Study Sites (3)

LKH Laas

Kötschach, Carintha, 9640, Austria

Location

Klinikum Klagenfurt

Klagenfurt, Carinthia, 9020, Austria

Location

LKH Villach

Villach, Carinthia, 9500, Austria

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Hannes Steinberger
• Organization: Landeskrankenanstalten-Betriebsgesellschaft

hannes.steinberger@kabeg.at

+4346355212 50303

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 18, 2012
• Study Start: February 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 23, 2015
• Results First Posted: July 1, 2015

Record last verified: 2015-04

Locations

AU (3)