Telemonitoring of Patients With COPD in Carinthia (RenewingHealth)
|ClinicalTrials.gov Identifier: NCT01580072|
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : July 1, 2015
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive (COPD)||Other: self-monitoring for patients with severe COPD Other: nurse-monitoring for patients with severe COPD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||February 2014|
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.
- 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. [ Time Frame: 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 [ Time Frame: 12 months ]
- Number of Bed Days for Hospitalised Patients [ Time Frame: 12 months ]
- Number of Primary Care Visits [ Time Frame: 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 [ Time Frame: 12 months ]
- Number of Consultations of Emergency Doctor [ Time Frame: 12 months ]
- All Cause Mortality [ Time Frame: 12 months ]deceased patients in respect to participating patients, by obituary column
- COPD Assessment Test CAT (Carinthia) [ Time Frame: 12 months ]No data available
- St. George's Respiratory Questionnaire SGRQ (Carinthia) [ Time Frame: 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) [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580072
|Kötschach, Carintha, Austria, 9640|
|Klagenfurt, Carinthia, Austria, 9020|
|Villach, Carinthia, Austria, 9500|