An interventional study of self-monitoring for patients with severe COPD and nurse-monitoring for patients with severe COPD in Pulmonary Disease, Chronic Obstructive (COPD), sponsored by Landeskrankenanstalten-Betriebsgesellschaft. Completed at 3 sites in Austria. Per ClinicalTrials.gov, last updated 2015-07-23.
Sponsored by Landeskrankenanstalten-Betriebsgesellschaft · Not applicable, Interventional, and Supportive care
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 65 is close to the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Landeskrankenanstalten-Betriebsgesellschaft is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the control group receive usual care.
Other: self-monitoring for patients with severe COPD
Other: nurse-monitoring for patients with severe COPD
Intervention Group entering vital parameters via Web Portal or automatic call center.
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.
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.
Time frame: 12 months
Number of Inpatient Stays
Time frame: 12 months
Number of Bed Days for Hospitalised Patients
Time frame: 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.
Time frame: 12 months
Number of Specialist Visits
Time frame: 12 months
Number of Consultations of Emergency Doctor
Time frame: 12 months
All Cause Mortality
deceased patients in respect to participating patients, by obituary column
Time frame: 12 months
COPD Assessment Test CAT (Carinthia)
No data available
Time frame: 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
Time frame: 12 months
BODE Index (Carinthia)
Time frame: 12 months
| Milestone | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| Started | 28 | 37 | 0 |
| Completed | 16 | 28 | 0 |
| Not completed | 12 | 9 | 0 |
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.
| units on a scale | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| physical functioning baseline | 35.0 ± 27.4 | 48.2 ± 24.5 | — |
| physical functioning after 12 months | 22.8 ± 15.4 | 39.8 ± 31.5 | — |
| role physical baseline | 19.5 ± 19.2 | 40.7 ± 20.0 | — |
| role physical after 12 months | 28.9 ± 20.9 | 35.9 ± 25.0 | — |
| bodily pain baseline | 59.1 ± 40.2 | 55.6 ± 28.8 | — |
| bodily pain after 12 months | 52.8 ± 39.1 | 55.3 ± 32.6 | — |
| general health baseline | 40.1 ± 26.7 | 49.3 ± 14.4 | — |
| general health after 12 months | 36.3 ± 21.3 | 47.3 ± 25.1 | — |
| vitality baseline | 38.3 ± 25.1 | 44.0 ± 16.4 | — |
| vitality after 12 months | 35.5 ± 22.4 | 44.6 ± 27.9 | — |
| social functioning baseline | 58.6 ± 36.7 | 67.4 ± 24.4 | — |
| social functioning after 12 months | 64.1 ± 36.8 | 61.2 ± 33.9 | — |
| role emotional baseline | 27.6 ± 28.7 | 53.4 ± 28.8 | — |
| role emotional after 12 months | 45.8 ± 29.0 | 53.7 ± 33.6 | — |
| mental health baseline | 53.1 ± 26.6 | 59.5 ± 19.9 | — |
| mental health after 12 months | 56.6 ± 27.8 | 59.6 ± 26.7 | — |
| physical component score baseline | 35.3 ± 11.3 | 38.1 ± 7.6 | — |
| physical component score after 12 months | 31.0 ± 9.2 | 36.1 ± 10.3 | — |
| mental component score baseline | 35.0 ± 13.1 | 41.8 ± 11.7 | — |
| mental component score after 12 months | 41.0 ± 14.6 | 42.7 ± 14.8 | — |
| inpatient stays | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| Number of Inpatient Stays | 1.54 ± 2.27 | 1.16 ± 1.91 | — |
| bed days | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| Number of Bed Days for Hospitalised Patients | 6.87 ± 6.78 | 4.92 ± 6.36 | — |
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.
| visits GP | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| Number of Primary Care Visits | 13.21 ± 10.27 | 9.67 ± 10.09 | — |
| visits specialists | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| Number of Specialist Visits | 3.31 ± 3.15 | 4.6 ± 5.03 | — |
| consultations ED | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| Number of Consultations of Emergency Doctor | 0.79 ± 1.03 | 1.17 ± 2.42 | — |
deceased patients in respect to participating patients, by obituary column
Results for this outcome have not been posted.
No data available
Results for this outcome have not been posted.
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
| units on a scale | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD |
|---|---|---|---|
| sympoms score baseline | 74.0 ± 20.1 | 69.0 ± 18.0 | — |
| sympoms score after 12 months | 67.4 ± 24.2 | 61.2 ± 27.6 | — |
| activity score baseline | 76.3 ± 17.2 | 68.9 ± 22.9 | — |
| activity score after 12 months | 79.3 ± 13.5 | 62.4 ± 28.4 | — |
| impacts score baseline | 55.1 ± 17.9 | 42.6 ± 20.9 | — |
| impacts score after 12 months | 54.3 ± 20.1 | 42.3 ± 23.3 | — |
| total score baseline | 64.8 ± 15.3 | 54.6 ± 18.1 | — |
| total score after 12 months | 64.2 ± 17.7 | 50.8 ± 24.0 | — |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/28 (0%) | 0/28 (0%) |
| Self Monitoring for Patients With COPD | — | 0/37 (0%) | 0/37 (0%) |
| Nurse Monitoring for Patients With COPD | — | — | — |
| Age, Continuous(years) | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD | Total |
|---|---|---|---|---|
| Mean | 73.62 ± 10.28 | 63.83 ± 7.69 | — | 68.04 ± 8.80 |
| Gender(participants) | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD | Total |
|---|---|---|---|---|
| Female | 10 | 11 | — | 21 |
| Male | 18 | 26 | — | 44 |
| Region of Enrollment(participants) | Control Group | Self Monitoring for Patients With COPD | Nurse Monitoring for Patients With COPD | Total |
|---|---|---|---|---|
| Austria | 28 | 37 | — | 65 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Landeskrankenanstalten-Betriebsgesellschaft