Telemonitoring of Patients With COPD in Carinthia

Pulmonary Disease, Chronic Obstructive (COPD) Clinical Trial

— RenewingHealth  

Official title:

REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580072
• Other study ID #: C250487
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: July 1, 2015
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Landeskrankenanstalten-Betriebsgesellschaft
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• COPD 3 or 4

• Be able to use the system provided

• Life expectancy > 12 months

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Disease, Chronic Obstructive (COPD)

Intervention

Other:
• self-monitoring for patients with severe COPD
Intervention Group entering vital parameters via Web Portal or automatic call center.
• nurse-monitoring for patients with severe COPD
Nurses are entering vital parameters of the patient with mobile devices.

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt	Klagenfurt	Carinthia
Austria	LKH Laas	Kötschach	Carintha
Austria	LKH Villach	Villach	Carinthia

Sponsors (2)

Lead Sponsor	Collaborator
Landeskrankenanstalten-Betriebsgesellschaft	European Commission

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of Inpatient Stays		12 months	No
Secondary	Number of Bed Days for Hospitalised Patients		12 months	No
Secondary	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	No
Secondary	Number of Specialist Visits		12 months	No
Secondary	Number of Consultations of Emergency Doctor		12 months	No
Secondary	All Cause Mortality	deceased patients in respect to participating patients, by obituary column	12 months	No
Secondary	COPD Assessment Test CAT (Carinthia)	No data available	12 months	No
Secondary	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	No
Secondary	BODE Index (Carinthia)		12 months	No