COPDNCT05269043
Advanced Telemonitoring of Patients With COPD in Home Environment
An observational study of COPD, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Medimonitor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Oct 2022to 1 Feb 2023
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease.
Who may be able to join
- COPD
- ≥ 60 years of age
- Informed written and verbal consent
- Ability to participate in study activities
Who cannot join
- Active smoking
- Respiratory failure requiring oxygenotherapy or ventilation support
- Severe psychological disturbances
- Absence of collaboration (informed consent)
- Other comorbid pulmonary disease
- Symptomatic heart failure
- Motor neuron diseases (e.g. amyotrophic lateral sclerosis etc.)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Respiratory Medicine, University Hospital Olomouc, Czech Republic
Olomouc, 77900
About this study
Official title: SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment
Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. The multimodal-telemedicine approach may provide a useful tool in the patient follow-up with the aim to reduce disease exacerbation rate and improve the health-related quality of life. The study aims to investigate the effects and utility of advanced telemonitoring in elderly COPD patients. All data will be integrated in a single web-based platform in order to analyse the mutual effects of different conditions and variables.
- Conditions
- COPD
- Being tested
- Medimonitor
- 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.
MedimonitorDevice
A digital solution consisting of smartphone/tablet based application gathering data from medical and other devices provided to the patients. These devices are as follows: tablet, smart inhaler, spirometer, blood pressure monitor, pulse oximetry device, particulate matter sensor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Telemetric spirometry - FVC
Evaluation of telemetric measurement of FVC in home enviroment in COPD patients wih use of mobile spirometer
Measured: 3 month
Telemetric spirometry - PEF
Evaluation of telemetric measurement of PEF in home enviroment in COPD patients wih use of mobile spirometer
Measured: 3 month
Telemetric spirometry - FEV1%
Evaluation of telemetric measurement of FEV1% in home enviroment in COPD patients wih use of mobile spirometer
Measured: 3 month
Telemetric spirometry - FEV1%/FVC ratio
Evaluation of telemetric measurement of FEV1%/FVC ratio in home enviroment in COPD patients wih use of mobile spirometer
Measured: 3 month
Blood oxygen saturation monitoring
Continuous measurement of blood oxygen saturation in the study group.
Measured: 3 month
Particulate matter concentration monitoring
Continuous measurement of both indoor and outdoor air-pollution levels via monitoring of selected parameters (PM1.0, PM2.5, PM4.0, PM10). and some other selected environmental parameters (humidity and temperature) - as well in both outdoor and indoor conditions.
Measured: 3 month
Environmental monitoring
Continuous measurement of selected environmental parameters (humidity and temperature) - in both outdoor and indoor conditions.
Measured: 3 month
Adherence monitoring - rate of inhalations per day
The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. Rate of inhalations per day is measured via special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Result is being compared with the amount of inhalations recommended by the physician.
Measured: 3 month
Adherence monitoring - time of inhalation deviation
The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. A specific time of inhalation is being recorded by a special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Deviation between recommended time of inhalation and real time of inhalation is being monitored through the study.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start14 Oct 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Stanke, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269043
- Sponsor's protocol ID
- SHAPES UC-PT3-COPD
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment
- ClinicalTrials.gov ID
- NCT05269043
- Acronym / sponsor ID
- SHAPES UC-PT3-COPD
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- 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.
Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. The multimodal-telemedicine approach may provide a useful tool in the patient follow-up with the aim to reduce disease exacerbation rate and improve the health-related quality of life. The study aims to investigate the effects and utility of advanced telemonitoring in elderly COPD patients. All data will be integrated in a single web-based platform in order to analyse the mutual effects of different conditions and variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obstructive pulmonary disease.
Key inclusion criteria (4 listed)
- COPD
- ≥ 60 years of age
- Informed written and verbal consent
- Ability to participate in study activities
Key exclusion criteria (7 listed)
- Active smoking
- Respiratory failure requiring oxygenotherapy or ventilation support
- Severe psychological disturbances
- Absence of collaboration (informed consent)
- Other comorbid pulmonary disease
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 |
|---|---|---|
| MedimonitorA digital solution consisting of smartphone/tablet based application gathering data from medical and other devices provided to the patients. These devices are as follows: tablet, smart inhaler, spirometer, blood pressure monitor, pulse oximetry device, particulate matter sensor. | Device | – |
Primary outcome
Telemetric spirometry - FVC
Time frame: 3 month
Evaluation of telemetric measurement of FVC in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - PEF
Time frame: 3 month
Evaluation of telemetric measurement of PEF in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - FEV1%
Time frame: 3 month
Evaluation of telemetric measurement of FEV1% in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - FEV1%/FVC ratio
Time frame: 3 month
Evaluation of telemetric measurement of FEV1%/FVC ratio in home enviroment in COPD patients wih use of mobile spirometer
Blood oxygen saturation monitoring
Time frame: 3 month
Continuous measurement of blood oxygen saturation in the study group.
Particulate matter concentration monitoring
Time frame: 3 month
Continuous measurement of both indoor and outdoor air-pollution levels via monitoring of selected parameters (PM1.0, PM2.5, PM4.0, PM10). and some other selected environmental parameters (humidity and temperature) - as well in both outdoor and indoor conditions.
Environmental monitoring
Time frame: 3 month
Continuous measurement of selected environmental parameters (humidity and temperature) - in both outdoor and indoor conditions.
Adherence monitoring - rate of inhalations per day
Time frame: 3 month
The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. Rate of inhalations per day is measured via special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Result is being compared with the amount of inhalations recommended by the physician.
Adherence monitoring - time of inhalation deviation
Time frame: 3 month
The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. A specific time of inhalation is being recorded by a special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Deviation between recommended time of inhalation and real time of inhalation is being monitored through the study.
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 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University Hospital Olomouc at 1 site in Czechia.
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 7 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 29 Jan 2024. 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 Czechia. 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?
Telemetric spirometry - FVC (time frame: 3 month). The study lists 9 primary outcomes in all. 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 29 Jan 2024.