Pulmonary Disease, Chronic Obstructive (COPD)
Conditions
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.
Interventions
Intervention Group entering vital parameters via Web Portal or automatic call center.
Nurses are entering vital parameters of the patient with mobile devices.
Sponsors
European Commission
Landeskrankenanstalten-Betriebsgesellschaft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* COPD 3 or 4 * Be able to use the system provided * Life expectancy \> 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Specialist Visits | 12 months | — |
| Number of Consultations of Emergency Doctor | 12 months | — |
| All Cause Mortality | 12 months | deceased patients in respect to participating patients, by obituary column |
| Number of Bed Days for Hospitalised Patients | 12 months | — |
| St. George's Respiratory Questionnaire SGRQ (Carinthia) | 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) | 12 months | — |
| COPD Assessment Test CAT (Carinthia) | 12 months | No data available |
| Number of Primary Care Visits | 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. |
Countries
Austria
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Participants in the control group receive usual care. | 28 |
| 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. | 37 |
| 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 |
| Total | 65 |
Baseline characteristics
| Characteristic | Control Group | Self Monitoring for Patients With COPD | Total |
|---|---|---|---|
| Age, Continuous | 73.62 years STANDARD_DEVIATION 10.28 | 63.83 years STANDARD_DEVIATION 7.69 | 68.04 years STANDARD_DEVIATION 8.8 |
| Gender Female | 10 participants | 11 participants | 21 participants |
| Gender Male | 18 participants | 26 participants | 44 participants |
| Region of Enrollment Austria | 28 participants | 37 participants | 65 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 37 | 0 / 0 |
| serious Total, serious adverse events | 0 / 28 | 0 / 37 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | 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. | physical functioning after 12 months | 22.8 units on a scale | Standard Deviation 15.4 |
| Control Group | 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. | vitality after 12 months | 35.5 units on a scale | Standard Deviation 22.4 |
| Control Group | 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. | bodily pain baseline | 59.1 units on a scale | Standard Deviation 40.2 |
| Control Group | 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. | social functioning after 12 months | 64.1 units on a scale | Standard Deviation 36.8 |
| Control Group | 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. | physical functioning baseline | 35.0 units on a scale | Standard Deviation 27.4 |
| Control Group | 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. | role emotional baseline | 27.6 units on a scale | Standard Deviation 28.7 |
| Control Group | 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. | bodily pain after 12 months | 52.8 units on a scale | Standard Deviation 39.1 |
| Control Group | 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. | role emotional after 12 months | 45.8 units on a scale | Standard Deviation 29 |
| Control Group | 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. | role physical baseline | 19.5 units on a scale | Standard Deviation 19.2 |
| Control Group | 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. | mental health baseline | 53.1 units on a scale | Standard Deviation 26.6 |
| Control Group | 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. | general health baseline | 40.1 units on a scale | Standard Deviation 26.7 |
| Control Group | 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. | mental health after 12 months | 56.6 units on a scale | Standard Deviation 27.8 |
| Control Group | 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. | social functioning baseline | 58.6 units on a scale | Standard Deviation 36.7 |
| Control Group | 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. | physical component score baseline | 35.3 units on a scale | Standard Deviation 11.3 |
| Control Group | 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. | general health after 12 months | 36.3 units on a scale | Standard Deviation 21.3 |
| Control Group | 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. | physical component score after 12 months | 31.0 units on a scale | Standard Deviation 9.2 |
| Control Group | 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. | mental component score baseline | 35.0 units on a scale | Standard Deviation 13.1 |
| Control Group | 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. | role physical after 12 months | 28.9 units on a scale | Standard Deviation 20.9 |
| Control Group | 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. | mental component score after 12 months | 41.0 units on a scale | Standard Deviation 14.6 |
| Control Group | 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. | vitality baseline | 38.3 units on a scale | Standard Deviation 25.1 |
| Self Monitoring for Patients With COPD | 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. | mental component score after 12 months | 42.7 units on a scale | Standard Deviation 14.8 |
| Self Monitoring for Patients With COPD | 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. | physical component score after 12 months | 36.1 units on a scale | Standard Deviation 10.3 |
| Self Monitoring for Patients With COPD | 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. | physical functioning baseline | 48.2 units on a scale | Standard Deviation 24.5 |
| Self Monitoring for Patients With COPD | 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. | physical functioning after 12 months | 39.8 units on a scale | Standard Deviation 31.5 |
| Self Monitoring for Patients With COPD | 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. | role physical baseline | 40.7 units on a scale | Standard Deviation 20 |
| Self Monitoring for Patients With COPD | 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. | role physical after 12 months | 35.9 units on a scale | Standard Deviation 25 |
| Self Monitoring for Patients With COPD | 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. | bodily pain baseline | 55.6 units on a scale | Standard Deviation 28.8 |
| Self Monitoring for Patients With COPD | 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. | bodily pain after 12 months | 55.3 units on a scale | Standard Deviation 32.6 |
| Self Monitoring for Patients With COPD | 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. | general health baseline | 49.3 units on a scale | Standard Deviation 14.4 |
| Self Monitoring for Patients With COPD | 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. | general health after 12 months | 47.3 units on a scale | Standard Deviation 25.1 |
| Self Monitoring for Patients With COPD | 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. | vitality baseline | 44.0 units on a scale | Standard Deviation 16.4 |
| Self Monitoring for Patients With COPD | 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. | social functioning baseline | 67.4 units on a scale | Standard Deviation 24.4 |
| Self Monitoring for Patients With COPD | 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. | social functioning after 12 months | 61.2 units on a scale | Standard Deviation 33.9 |
| Self Monitoring for Patients With COPD | 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. | role emotional baseline | 53.4 units on a scale | Standard Deviation 28.8 |
| Self Monitoring for Patients With COPD | 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. | role emotional after 12 months | 53.7 units on a scale | Standard Deviation 33.6 |
| Self Monitoring for Patients With COPD | 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. | mental health baseline | 59.5 units on a scale | Standard Deviation 19.9 |
| Self Monitoring for Patients With COPD | 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. | mental health after 12 months | 59.6 units on a scale | Standard Deviation 26.7 |
| Self Monitoring for Patients With COPD | 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. | physical component score baseline | 38.1 units on a scale | Standard Deviation 7.6 |
| Self Monitoring for Patients With COPD | 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. | mental component score baseline | 41.8 units on a scale | Standard Deviation 11.7 |
| Self Monitoring for Patients With COPD | 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. | vitality after 12 months | 44.6 units on a scale | Standard Deviation 27.9 |
Primary
Number of Inpatient Stays
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Inpatient Stays | 1.54 inpatient stays | Standard Deviation 2.27 |
| Self Monitoring for Patients With COPD | Number of Inpatient Stays | 1.16 inpatient stays | Standard Deviation 1.91 |
Secondary
All Cause Mortality
deceased patients in respect to participating patients, by obituary column
Time frame: 12 months
Secondary
BODE Index (Carinthia)
Time frame: 12 months
Secondary
COPD Assessment Test CAT (Carinthia)
No data available
Time frame: 12 months
Secondary
Number of Bed Days for Hospitalised Patients
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Bed Days for Hospitalised Patients | 6.87 bed days | Standard Deviation 6.78 |
| Self Monitoring for Patients With COPD | Number of Bed Days for Hospitalised Patients | 4.92 bed days | Standard Deviation 6.36 |
Secondary
Number of Consultations of Emergency Doctor
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Consultations of Emergency Doctor | 0.79 consultations ED | Standard Deviation 1.03 |
| Self Monitoring for Patients With COPD | Number of Consultations of Emergency Doctor | 1.17 consultations ED | Standard Deviation 2.42 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Primary Care Visits | 13.21 visits GP | Standard Deviation 10.27 |
| Self Monitoring for Patients With COPD | Number of Primary Care Visits | 9.67 visits GP | Standard Deviation 10.09 |
Secondary
Number of Specialist Visits
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Specialist Visits | 3.31 visits specialists | Standard Deviation 3.15 |
| Self Monitoring for Patients With COPD | Number of Specialist Visits | 4.6 visits specialists | Standard Deviation 5.03 |
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
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | sympoms score baseline | 74.0 units on a scale | Standard Deviation 20.1 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | impacts score baseline | 55.1 units on a scale | Standard Deviation 17.9 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | sympoms score after 12 months | 67.4 units on a scale | Standard Deviation 24.2 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | activity score baseline | 76.3 units on a scale | Standard Deviation 17.2 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | activity score after 12 months | 79.3 units on a scale | Standard Deviation 13.5 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | impacts score after 12 months | 54.3 units on a scale | Standard Deviation 20.1 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | total score baseline | 64.8 units on a scale | Standard Deviation 15.3 |
| Control Group | St. George's Respiratory Questionnaire SGRQ (Carinthia) | total score after 12 months | 64.2 units on a scale | Standard Deviation 17.7 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | activity score baseline | 68.9 units on a scale | Standard Deviation 22.9 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | sympoms score baseline | 69.0 units on a scale | Standard Deviation 18 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | total score after 12 months | 50.8 units on a scale | Standard Deviation 24 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | impacts score after 12 months | 42.3 units on a scale | Standard Deviation 23.3 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | impacts score baseline | 42.6 units on a scale | Standard Deviation 20.9 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | activity score after 12 months | 62.4 units on a scale | Standard Deviation 28.4 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | sympoms score after 12 months | 61.2 units on a scale | Standard Deviation 27.6 |
| Self Monitoring for Patients With COPD | St. George's Respiratory Questionnaire SGRQ (Carinthia) | total score baseline | 54.6 units on a scale | Standard Deviation 18.1 |