Pulmonary Disease, Chronic ObstructiveRHCluster4GRNCT01489241
Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation
A study testing Telemonitoring in people with Pulmonary Disease, Chronic Obstructive, run by Regional Health Authority of Sterea & Thessaly at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Telemonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exacerbation of COPD according to the GOLD guidelines
- Age > 40 years
- Capability to use the devices provided
- Willing to participate
Who cannot join
- included in previous COPD monitoring study
Trial locations and contacts
1 site in 1 country.
Greece1 site
Pulmonary Department - Regional University Hospital of Larisa
Larissa, Thessaly, 41110
About this study
Official title: Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation
The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.
Read the detailed description
The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. Following this; it is also hypothesized that this will also lead to less patients' deaths. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Telemonitoring
- Keywords
- Pulmonary Disease, Chronic Obstructive, Telemedicine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringProcedure or surgery
Within 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment. Patients are followed by a dedicated telehealth centre. Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications. Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks. When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed. In the case of clinical deterioration during the study, the patients contact as usual their general practitioner. Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed |
| Telemonitoring | Experimental | Not described Receives: Procedure: Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital readmissions
Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation
Measured: 3 months period
Secondary outcomes (6)
Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
Measured: 3 months - at the entry point of the intervention and the end.
Hospital anxiety and depression scale HADS
Hospital anxiety and depression scale HADS
Measured: 3 months - at the entry point of the intervention and the end.
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Measured: 3 months - at the entry point of the intervention and the end.
Lung condition as measured by FEV1
Lung condition as measured by FEV1
Measured: 1 month after the hospital discharge.
Mortality
Mortality
Measured: 3 months period
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring)
Measured: at the 3rd month of the tele-monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Health Authority of Sterea & Thessaly
- Sponsor type
- Other government
- Collaborators
- Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly
- Responsible party
- Principal investigator, Konstantinos Gourgoulianis, Regional Health Authority of Sterea & Thessaly
- Investigators
- Konstantinos Gourgoulianis, MD, PhD, Principal investigator, Pulmonary Department - University Hospital of Larisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489241
- Sponsor's protocol ID
- FR2017
- Other IDs
- EC Grant Agreement 250487
- Acronym
- RHCluster4GR
- Status last verified
- Feb 2015
- First submitted
- 6 Dec 2011
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
PubMed 20197355
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation
- ClinicalTrials.gov ID
- NCT01489241
- Acronym / sponsor ID
- RHCluster4GR / FR2017
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Regional Health Authority of Sterea & ThessalyOther government
- Collaborators
- Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.
Detailed description
The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. Following this; it is also hypothesized that this will also lead to less patients' deaths. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed. In the case of clinical deterioration during the study, the patients contact as usual their general practitioner. Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed |
| Telemonitoring | Experimental | Procedure: Telemonitoring |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Exacerbation of COPD according to the GOLD guidelines
- Age > 40 years
- Capability to use the devices provided
- Willing to participate
Key exclusion criteria (1 listed)
- included in previous COPD monitoring study
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 |
|---|---|---|
| TelemonitoringWithin 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment. Patients are followed by a dedicated telehealth centre. Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications. Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks. When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre. | Procedure or surgery | Telemonitoring |
Primary outcome
Number of hospital readmissions
Time frame: 3 months period
Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation
6 secondary outcomes
Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
Time frame: 3 months - at the entry point of the intervention and the end.
Hospital anxiety and depression scale HADS
Time frame: 3 months - at the entry point of the intervention and the end.
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Time frame: 3 months - at the entry point of the intervention and the end.
Lung condition as measured by FEV1
Time frame: 1 month after the hospital discharge.
Mortality
Time frame: 3 months period
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time frame: at the 3rd month of the tele-monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
- Background: PubMed 20197355Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
- "The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community"Link provided by the sponsor.
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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.
Konstantinos Gourgoulianis, MD, PhD principal investigator
Pulmonary Department - University Hospital of Larisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Pulmonary Disease, Chronic Obstructive, run by Regional Health Authority of Sterea & Thessaly at 1 site in Greece.
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 4 inclusion and 1 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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of hospital readmissions (time frame: 3 months period). 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 NCT01489241, which also lists 1 linked publication.
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 24 Feb 2015.