Chronic Obstructive Pulmonary Disease, COPDNCT02615795
Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease
A study testing Tele Monitoring, using Tunstall monitoring device in people with Chronic Obstructive Pulmonary Disease, COPD, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Tele Monitoring, using Tunstall monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to 6 Jun 2018
- 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
- Chronic Obstructive Pulmonary Disease COPD with FEV1/FVC (Forced Expiratory Volume in 1 second / Forced Vital Capacity) below 70% at all times during the study. FEV1 below 51% during inclusion and during the further study. Inclusion takes place during a hospitalization, with exacerbation in pulmonary symptoms.
Who cannot join
- Not able to give written or oral consent
- Terminal disease, such as cancer
- Unstable heart disease, such as coronary infarction within the last to month
- Disabling psychiatric disease
- Asthma
- Inability to use the equipment
Show all 9Show fewer
- Severe language barriers
- Drug abuse
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease. A Clinical, Randomized, Controlled Study for Evaluation of Clinical and Economic Consequences of Monitoring Service
The aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. The patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.
Read the detailed description
Telemedicine is a relatively new approach for the management of chronic obstructive pulmonary disease (COPD) disease. Telemedicine, for monitoring disease exacerbation, is the focus area of our research. The patient monitoring offers the possibility of early initiation of treatment of patients who has evidence of COPD exacerbation or pulmonary infection. The self-monitoring of potential exacerbation is started after a hospitalization, and is done by the patient on a daily (not on weekends) basis initially. After one month the monitoring is made at least three times weekly during the rest of the intervention period of six months. With the help of the monitoring equipment, the patient answers a short series of health related questions, and makes simple measurements of oxygen saturation, heart rate, lung function and weight. Data is sent to the hospital, and here the staff can assess the data and respond to them the same day, with a phone call to the patient, if the patient's condition has changed. The selected telemonitoring-equipment, consists of a monitoring systems for the assessment of key clinical parameters and symptoms. All patients, in the intervention group as well as in the control group, are trained in the use of a standardized self-treatment plan. It is expected that the monitoring of symptoms and signs will support patient empowerment.
The investigation is planned to assess the clinical and economic effects of the intervention.
- Being tested
- Tele Monitoring, using Tunstall monitoring device
- 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.
Tele Monitoring, using Tunstall monitoring deviceDevice
Also called Tunstall monitoring device
Monitoring of symptoms and physiological parameters at home, using Tunstall Healthcare telemedicine equipment. Patients perform physiological measurement. In addition, they correspond to a standardized questionnaire regarding disease specific symptoms. Data is assessed by the medical staff the same day. If the data indicates worsening in the patient's condition, the patient is contacted by phone. The assessment of the patient is made either on the specialist nurse level, or at a conference between the specialist nurse and a senior pulmonary doctor. There is no call center service.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Best practice |
| Intervention | Experimental | Best practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device. Receives: Device: Tele Monitoring, using Tunstall monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalization days
Measured: During twelve months
Secondary outcomes (9)
Duration of COPD related hospitalizations, in days
Measured: Twelve months
Number of hospitalizations caused by COPD exacerbation
Measured: During twelve months
Number of COPD related contacts to emergency rooms
Measured: Twelve months
Number of self-addressed COPD exacerbations
Without primary contact to medical staff
Measured: Twelve months
Sensitivity of physiological measurements in detecting COPD exacerbation
Relation between physiological measurements and COPD exacerbation
Measured: During six months of intervention
Number of unplanned contact to primary health sector
Contacts to general practitioner or Doctor on call in the primary health sector
Measured: Twelve months
Health related quality of life
Saint George´s respiratory questionnaire, Hospital Anxiety and Depression score, SF-36 questionnaire
Measured: Twelve months
Number of all cause contacts to primary health sector
Contacts to general practitioner or Doctor on call in the primary health sector
Measured: Twelve months
Mortality
Measured: During twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startMar 2011
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease, COPDStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank D Andersen, MD, Principal investigator, Diagnostic Center, Regional Hospital of Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615795
- Sponsor's protocol ID
- UAarhusFA
- Status last verified
- Oct 2010
- First submitted
- 18 Nov 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease. A Clinical, Randomized, Controlled Study for Evaluation of Clinical and Economic Consequences of Monitoring Service
- ClinicalTrials.gov ID
- NCT02615795
- Acronym / sponsor ID
- UAarhusFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 26 Nov 2015 (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 aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. The patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.
Detailed description
Telemedicine is a relatively new approach for the management of chronic obstructive pulmonary disease (COPD) disease. Telemedicine, for monitoring disease exacerbation, is the focus area of our research. The patient monitoring offers the possibility of early initiation of treatment of patients who has evidence of COPD exacerbation or pulmonary infection. The self-monitoring of potential exacerbation is started after a hospitalization, and is done by the patient on a daily (not on weekends) basis initially. After one month the monitoring is made at least three times weekly during the rest of the intervention period of six months. With the help of the monitoring equipment, the patient answers a short series of health related questions, and makes simple measurements of oxygen saturation, heart rate, lung function and weight. Data is sent to the hospital, and here the staff can assess the data and respond to them the same day, with a phone call to the patient, if the patient's condition has changed. The selected telemonitoring-equipment, consists of a monitoring systems for the assessment of key clinical parameters and symptoms. All patients, in the intervention group as well as in the control group, are trained in the use of a standardized self-treatment plan. It is expected that the monitoring of symptoms and signs will support patient empowerment.
The investigation is planned to assess the clinical and economic effects of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Best practice |
| Intervention | Experimental | Device: Tele Monitoring, using Tunstall monitoring deviceBest practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Obstructive Pulmonary Disease COPD with FEV1/FVC (Forced Expiratory Volume in 1 second / Forced Vital Capacity) below 70% at all times during the study. FEV1 below 51% during inclusion and during the further study. Inclusion takes place during a hospitalization, with exacerbation in pulmonary symptoms.
Key exclusion criteria (9 listed)
- Not able to give written or oral consent
- Terminal disease, such as cancer
- Unstable heart disease, such as coronary infarction within the last to month
- Disabling psychiatric disease
- Asthma
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 |
|---|---|---|
| Tele Monitoring, using Tunstall monitoring deviceAlso: Tunstall monitoring deviceMonitoring of symptoms and physiological parameters at home, using Tunstall Healthcare telemedicine equipment. Patients perform physiological measurement. In addition, they correspond to a standardized questionnaire regarding disease specific symptoms. Data is assessed by the medical staff the same day. If the data indicates worsening in the patient's condition, the patient is contacted by phone. The assessment of the patient is made either on the specialist nurse level, or at a conference between the specialist nurse and a senior pulmonary doctor. There is no call center service. | Device | Intervention |
Primary outcome
Number of hospitalization days
Time frame: During twelve months
9 secondary outcomes
Duration of COPD related hospitalizations, in days
Time frame: Twelve months
Number of hospitalizations caused by COPD exacerbation
Time frame: During twelve months
Number of COPD related contacts to emergency rooms
Time frame: Twelve months
Number of self-addressed COPD exacerbations
Time frame: Twelve months
Sensitivity of physiological measurements in detecting COPD exacerbation
Time frame: During six months of intervention
Number of unplanned contact to primary health sector
Time frame: Twelve months
Health related quality of life
Time frame: Twelve months
Number of all cause contacts to primary health sector
Time frame: Twelve months
Mortality
Time frame: During twelve months
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 2 Oct 2019.
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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.
Frank D Andersen, MD principal investigator
Diagnostic Center, Regional Hospital of Silkeborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele Monitoring, using Tunstall monitoring device in people with Chronic Obstructive Pulmonary Disease, COPD, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 9 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 2 Oct 2019. 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 Denmark. 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 hospitalization days (time frame: During twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.