Pulmonary Disease, Chronic Obstructive (COPD)RenewingHealthNCT01580072

Telemonitoring of Patients With COPD in Carinthia

A study testing self-monitoring for patients with severe COPD and nurse-monitoring for patients with severe COPD in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Landeskrankenanstalten-Betriebsgesellschaft at 3 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Pulmonary Disease, Chronic Obstructive (COPD)
What is being tested?: self-monitoring for patients with severe COPD and nurse-monitoring for patients with severe COPD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 3 sitesAustria
Study dates: Feb 2010to Feb 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

COPD 3 or 4
Be able to use the system provided
Life expectancy > 12 months

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Austria3 sites

Klinikum Klagenfurt
Klagenfurt, Carinthia, 9020
LKH Laas
Kötschach, Carintha, 9640
LKH Villach
Villach, Carinthia, 9500

Other trials in Austria

About this study

Official title: REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)

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.

Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Being tested: self-monitoring for patients with severe COPD, nurse-monitoring for patients with severe COPD
Medical subject headings: Lung Diseases, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

self-monitoring for patients with severe COPDOther
Intervention Group entering vital parameters via Web Portal or automatic call center.
nurse-monitoring for patients with severe COPDOther
Nurses are entering vital parameters of the patient with mobile devices.

Study groups in NCT01580072
Study group	Role	What they receive
Control group	No intervention	Participants in the control group receive usual care.
Self monitoring for patients with COPD	Experimental	Not described Receives: Other: self-monitoring for patients with severe COPD
Nurse monitoring for patients with COPD	Experimental	Not described Receives: Other: nurse-monitoring for patients with severe COPD

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months
Number of Inpatient Stays
Measured: 12 months

Secondary outcomes (8)

Number of Bed Days for Hospitalised Patients
Measured: 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.
Measured: 12 months
Number of Specialist Visits
Measured: 12 months
Number of Consultations of Emergency Doctor
Measured: 12 months
All Cause Mortality
deceased patients in respect to participating patients, by obituary column
Measured: 12 months
COPD Assessment Test CAT (Carinthia)
No data available
Measured: 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
Measured: 12 months
BODE Index (Carinthia)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Feb 2014

First posted18 Apr 2012 (estimated)
Study startFeb 2010
Primary completionJul 2013
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic Obstructive (COPD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01580072
Sponsor's protocol ID: C250487
Acronym: RenewingHealth
Status last verified: Apr 2015
First submitted: 17 Apr 2012
Last updated: 23 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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All Pulmonary Disease, Chronic Obstructive (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)
ClinicalTrials.gov ID: NCT01580072
Acronym / sponsor ID: RenewingHealth / C250487
Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Landeskrankenanstalten-BetriebsgesellschaftIndustry (pharma, biotech, devices)
Collaborators: European Commission
Study start: Feb 2010
Primary completion: Jul 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 18 Apr 2012 (estimated)
Results: Posted 1 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–Participants in the control group receive usual care.
Self monitoring for patients with COPD	Experimental	Other: self-monitoring for patients with severe COPD
Nurse monitoring for patients with COPD	Experimental	Other: nurse-monitoring for patients with severe COPD

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

COPD 3 or 4
Be able to use the system provided
Life expectancy > 12 months

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
self-monitoring for patients with severe COPDIntervention Group entering vital parameters via Web Portal or automatic call center.	Other	Self monitoring for patients with COPD
nurse-monitoring for patients with severe COPDNurses are entering vital parameters of the patient with mobile devices.	Other	Nurse monitoring for patients with COPD

Primary outcome

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

8 secondary outcomes

Number of Bed Days for Hospitalised Patients
Time frame: 12 months
Number of Primary Care Visits
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
Time frame: 12 months
COPD Assessment Test CAT (Carinthia)
Time frame: 12 months
St. George's Respiratory Questionnaire SGRQ (Carinthia)
Time frame: 12 months
BODE Index (Carinthia)
Time frame: 12 months

Results and safety

Results posted to the registry on 1 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	28	16
Self Monitoring for Patients With COPD	37	28
Nurse Monitoring for Patients With COPD	0	0

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Control Group n = 16	Self Monitoring for Patients With COPD n = 28	Nurse Monitoring for Patients With COPD n = 0
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)	–

Primary outcome: Number of Inpatient Stays

Time frame: 12 months. Mean (Standard Deviation). Unit: inpatient stays

Measure	Control Group n = 28	Self Monitoring for Patients With COPD n = 37	Nurse Monitoring for Patients With COPD n = 0
Value	1.54 (2.27)	1.16 (1.91)	–

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 28 (0%)	0 of 28 (0%)	Not reported
Self Monitoring for Patients With COPD	0 of 37 (0%)	0 of 37 (0%)	Not reported
Nurse Monitoring for Patients With COPD	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Disease, Chronic Obstructive (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01580072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.