Trial Outcomes & Findings for Telemonitoring of Patients With COPD in Carinthia (NCT NCT01580072)
NCT ID: NCT01580072
Last Updated: 2015-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
12 months
Results posted on
2015-07-23
Participant Flow
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.
Participant milestones
| Measure |
Control Group
Participants in the control group receive usual care.
|
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.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
37
|
0
|
|
Overall Study
COMPLETED
|
16
|
28
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telemonitoring of Patients With COPD in Carinthia
Baseline characteristics by cohort
| Measure |
Control Group
n=28 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=37 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.62 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
63.83 years
STANDARD_DEVIATION 7.69 • n=7 Participants
|
—
|
68.04 years
STANDARD_DEVIATION 8.80 • n=4 Participants
|
|
Gender
Female
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
—
|
21 participants
n=4 Participants
|
|
Gender
Male
|
18 participants
n=5 Participants
|
26 participants
n=7 Participants
|
—
|
44 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
28 participants
n=5 Participants
|
37 participants
n=7 Participants
|
—
|
65 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsBaseline 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.
Outcome measures
| Measure |
Control Group
n=16 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=28 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
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.
physical functioning baseline
|
35.0 units on a scale
Standard Deviation 27.4
|
48.2 units on a scale
Standard Deviation 24.5
|
—
|
|
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
|
39.8 units on a scale
Standard Deviation 31.5
|
—
|
|
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
|
40.7 units on a scale
Standard Deviation 20.0
|
—
|
|
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
|
35.9 units on a scale
Standard Deviation 25.0
|
—
|
|
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
|
55.6 units on a scale
Standard Deviation 28.8
|
—
|
|
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
|
55.3 units on a scale
Standard Deviation 32.6
|
—
|
|
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
|
49.3 units on a scale
Standard Deviation 14.4
|
—
|
|
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
|
47.3 units on a scale
Standard Deviation 25.1
|
—
|
|
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
|
44.0 units on a scale
Standard Deviation 16.4
|
—
|
|
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
|
44.6 units on a scale
Standard Deviation 27.9
|
—
|
|
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
|
67.4 units on a scale
Standard Deviation 24.4
|
—
|
|
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
|
61.2 units on a scale
Standard Deviation 33.9
|
—
|
|
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
|
53.4 units on a scale
Standard Deviation 28.8
|
—
|
|
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 29.0
|
53.7 units on a scale
Standard Deviation 33.6
|
—
|
|
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
|
59.5 units on a scale
Standard Deviation 19.9
|
—
|
|
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
|
59.6 units on a scale
Standard Deviation 26.7
|
—
|
|
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
|
38.1 units on a scale
Standard Deviation 7.6
|
—
|
|
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
|
36.1 units on a scale
Standard Deviation 10.3
|
—
|
|
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
|
41.8 units on a scale
Standard Deviation 11.7
|
—
|
|
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
|
42.7 units on a scale
Standard Deviation 14.8
|
—
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Control Group
n=28 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=37 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
Number of Inpatient Stays
|
1.54 inpatient stays
Standard Deviation 2.27
|
1.16 inpatient stays
Standard Deviation 1.91
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Control Group
n=28 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=37 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
Number of Bed Days for Hospitalised Patients
|
6.87 bed days
Standard Deviation 6.78
|
4.92 bed days
Standard Deviation 6.36
|
—
|
SECONDARY outcome
Timeframe: 12 monthsNot 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.
Outcome measures
| Measure |
Control Group
n=19 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=30 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
Number of Primary Care Visits
|
13.21 visits GP
Standard Deviation 10.27
|
9.67 visits GP
Standard Deviation 10.09
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Control Group
n=19 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=30 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
Number of Specialist Visits
|
3.31 visits specialists
Standard Deviation 3.15
|
4.6 visits specialists
Standard Deviation 5.03
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Control Group
n=19 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=30 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
Number of Consultations of Emergency Doctor
|
0.79 consultations ED
Standard Deviation 1.03
|
1.17 consultations ED
Standard Deviation 2.42
|
—
|
SECONDARY outcome
Timeframe: 12 monthsdeceased patients in respect to participating patients, by obituary column
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNo data available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsThe 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
Outcome measures
| Measure |
Control Group
n=16 Participants
Participants in the control group receive usual care.
|
Self Monitoring for Patients With COPD
n=25 Participants
self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
|
Nurse Monitoring for Patients With COPD
nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
|
|---|---|---|---|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
sympoms score baseline
|
74.0 units on a scale
Standard Deviation 20.1
|
69.0 units on a scale
Standard Deviation 18.0
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
sympoms score after 12 months
|
67.4 units on a scale
Standard Deviation 24.2
|
61.2 units on a scale
Standard Deviation 27.6
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
activity score baseline
|
76.3 units on a scale
Standard Deviation 17.2
|
68.9 units on a scale
Standard Deviation 22.9
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
activity score after 12 months
|
79.3 units on a scale
Standard Deviation 13.5
|
62.4 units on a scale
Standard Deviation 28.4
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
impacts score baseline
|
55.1 units on a scale
Standard Deviation 17.9
|
42.6 units on a scale
Standard Deviation 20.9
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
impacts score after 12 months
|
54.3 units on a scale
Standard Deviation 20.1
|
42.3 units on a scale
Standard Deviation 23.3
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
total score baseline
|
64.8 units on a scale
Standard Deviation 15.3
|
54.6 units on a scale
Standard Deviation 18.1
|
—
|
|
St. George's Respiratory Questionnaire SGRQ (Carinthia)
total score after 12 months
|
64.2 units on a scale
Standard Deviation 17.7
|
50.8 units on a scale
Standard Deviation 24.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self Monitoring for Patients With COPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nurse Monitoring for Patients With COPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hannes Steinberger
Landeskrankenanstalten-Betriebsgesellschaft
Phone: +4346355212 50303
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place