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| Name | Class |
|---|---|
| European Commission | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in the control group receive usual care. | |
| Self monitoring for patients with COPD | Experimental |
| |
| Nurse monitoring for patients with COPD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-monitoring for patients with severe COPD | Other | Intervention Group entering vital parameters via Web Portal or automatic call center. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Laas | Kötschach | Carintha | 9640 | Austria | ||
| Klinikum Klagenfurt |
Due to organisational changes in the participating home nursing organisation and due to the age of the patients no nurse monitoring patients were admitted. Furthermore a first examination in the hospitals seemed to be hindering for these patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants in the control group receive usual care. |
| FG001 | Self Monitoring for Patients With COPD | self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center. |
| FG002 | Nurse Monitoring for Patients With COPD | nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Participants in the control group receive usual care. |
| BG001 | Self Monitoring for Patients With COPD | self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants in the control group receive usual care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hannes Steinberger | Landeskrankenanstalten-Betriebsgesellschaft | +4346355212 50303 | hannes.steinberger@kabeg.at |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| nurse-monitoring for patients with severe COPD | Other | Nurses are entering vital parameters of the patient with mobile devices. |
|
| 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 |
| Klagenfurt |
| Carinthia |
| 9020 |
| Austria |
| LKH Villach | Villach | Carinthia | 9500 | Austria |
| BG002 | Nurse Monitoring for Patients With COPD | nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center. |
| OG002 | Nurse Monitoring for Patients With COPD | nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices. |
|
|
| Primary | Number of Inpatient Stays | Posted | Mean | Standard Deviation | inpatient stays | 12 months |
|
|
|
| Secondary | Number of Bed Days for Hospitalised Patients | Posted | Mean | Standard Deviation | bed days | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | visits GP | 12 months |
|
|
|
| Secondary | Number of Specialist Visits | Posted | Mean | Standard Deviation | visits specialists | 12 months |
|
|
|
| Secondary | Number of Consultations of Emergency Doctor | Posted | Mean | Standard Deviation | consultations ED | 12 months |
|
|
|
| Secondary | All Cause Mortality | deceased patients in respect to participating patients, by obituary column | Not Posted | 12 months |
| Secondary | COPD Assessment Test CAT (Carinthia) | No data available | Not Posted | 12 months |
| 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | BODE Index (Carinthia) | Not Posted | 12 months |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Self Monitoring for Patients With COPD | self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center. | 0 | 37 | 0 | 37 |
| EG002 | Nurse Monitoring for Patients With COPD | nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices. | 0 | 0 | 0 | 0 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| activity score baseline |
|
| activity score after 12 months |
|
| impacts score baseline |
|
| impacts score after 12 months |
|
| total score baseline |
|
| total score after 12 months |
|