COPDNCT02791451

Predicting Exacerbation of COPD With Wireless Telemonitoring

A study testing telemonitoring in people with COPD, run by Turku University Hospital.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is an open-label single-center 6-month prospective clinical trial predicting exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the Turku University Hospital due to acute exacerbation of COPD. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COPD
What is being tested?: telemonitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: No sites listed yet
Study dates: Oct 2016to Dec 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Consecutive patients treated due to acute exacerbation of COPD at the pulmonary wards of the Turku University Hospital

Who cannot join

Those sleeping with a bed partner and not having separate mattresses
Patients with pacemaker

About this study

Official title: Open-Label Prospective Study of Predicting Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) With Wireless Telemonitoring of Respiratory Rate, Heart Rate and Sleep

Read the detailed description

A bed sensor based on ballistocardiogram (BCG) will be used to wireless telemonitoring of respiratory rate, heart rate and sleep for six months after an acute exacerbation of COPD.

Conditions: COPD
Being tested: telemonitoring
Keywords: COPD, telemonitoring, exacerbation
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.

telemonitoringDevice
To predict exacerbation of COPD with wireless telemonitoring

Study groups in NCT02791451
Study group	Role	What they receive
Telemonitoring	Experimental	Exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep. Receives: Device: telemonitoring

What is being measured

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

Time window to detect acute exacerbation of COPD
Time window to detect acute exacerbation of COPD
Measured: Six months

Timeline

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

Oct 2016Dec 2017

First posted6 Jun 2016 (estimated)
Study startOct 2016
Primary completionDec 2017
Study completionDec 2017

Why it stopped: The device did not provide sufficient quality of data

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02791451
Sponsor's protocol ID: COPD_BCG
Status last verified: Apr 2021
First submitted: 1 Jun 2016
Last updated: 15 Apr 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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?

Official record

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Prospective Study of Predicting Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) With Wireless Telemonitoring of Respiratory Rate, Heart Rate and Sleep
ClinicalTrials.gov ID: NCT02791451
Acronym / sponsor ID: COPD_BCG
Conditions: COPD
Keywords: COPD, telemonitoring, exacerbation
Study type: Interventional
Recruitment status: TerminatedReason stopped: The device did not provide sufficient quality of data
Enrolment: 6 participants (actual)
Lead sponsor: Turku University HospitalOther government
Collaborators: University of Turku
Study start: Oct 2016
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 6 Jun 2016 (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.

Detailed description

A bed sensor based on ballistocardiogram (BCG) will be used to wireless telemonitoring of respiratory rate, heart rate and sleep for six months after an acute exacerbation of COPD.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Telemonitoring	Experimental	Device: telemonitoringExacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Consecutive patients treated due to acute exacerbation of COPD at the pulmonary wards of the Turku University Hospital

Key exclusion criteria (2 listed)

Those sleeping with a bed partner and not having separate mattresses
Patients with pacemaker

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
telemonitoringTo predict exacerbation of COPD with wireless telemonitoring	Device	Telemonitoring

Primary outcome

Time window to detect acute exacerbation of COPD
Time frame: Six months
Time window to detect acute exacerbation of COPD

Results and safety

The study was stopped early (reason given: The device did not provide sufficient quality of data). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Individual participant dataSharing planned: No

Related trials for COPD

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

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.

Questions about this trial

What is this clinical trial studying?

A study testing telemonitoring in people with COPD, run by Turku University Hospital.

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 2 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: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: The device did not provide sufficient quality of data). Results are not available in the source record.

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?

Time window to detect acute exacerbation of COPD (time frame: Six months). 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 NCT02791451.

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 15 Apr 2021.