COPD ExacerbationSENSORNCT06118632
Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD Exacerbation, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Observational
- How many people
- 131 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2023to 24 May 2026
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients admitted in hospital
Who may be able to join
- Aged 18 or over.
- Diagnosis of COPD, currently admitted to hospital and clinically stable with a confirmed acute exacerbation of COPD.
- Ownership of a smartphone (iOS version 13 or above, Android version 8 or above).
- Able to provide informed consent to participate in study.
Who cannot join
- Patients who require less than 24 hours in hospital at initial visit.
- Patients deemed unlikely to cooperate with study requirements.
- Patients with implantable devices.
- Patient not felt to be suitable for research enrolment by admitting clinical team.
- Patients requiring non-invasive ventilation or deemed to have a life-expectancy of less than 90 days following discharge.
Trial locations and contacts
1 site in 1 country.
About this study
The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. This device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. This could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether.
The study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition.
- Conditions
- COPD Exacerbation
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the volume and quality of the data collected in terms of:
Total number of subjects: number of subjects who completed the on boarding stage of the study
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Dropout rate: proportion of subjects who dropped out (withdrew from study or stopped using the app/connected device prior to the off-boarding process or had to exit the trial due to deterioration)
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Median time to dropout, where time to dropout is the number of days between subject's enrolment date and drop-out date (either date of withdrawal/exit from the study or date when subject stopped using the app and connected device entirely)
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Number of participants who provided passive measurements for minimum of 50% of the study period
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Number of participants who provided minimum of 33% of measures requiring active input from user
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Data completeness: proportion of missing and total number of data points
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Data consistency across sources: where similar information is recorded in multiple modules (e.g., breathlessness scale and symptom tracker), proportion of records in which consistent answers were provided will be reported
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Proportion of data within admissible value range, where admissible value range will be determined based on literature or clinical guidance
Measured: 3 months
To assess the volume and quality of the data collected in terms of:
Similarity of collected data distribution to expected data distribution, where expected data distribution will be determined based on literature and similarity of the two distributions evaluated by a suitable statistical technique (e.g., Kolmogorov-Smirnov test)
Measured: 3 months
Secondary outcomes (5)
To ascertain whether marked physiological events can be detected using smartphone and connected device sensors in a remote setting.
Using clinical endpoints such as exacerbation events and readmission to predict exacerbation episodes
Measured: 3 months
To assess the relationship between patient-generated data gathered from smartphone and connected devices and conventional clinical measures at point of readmission.
The prediction of physiological measures at readmission (e.g., pulse rate, respiratory rate, pH, FBC, CRP, and CXR appearance) can be addressed as a regression task and evaluated with metrics such as root mean squared error (RMSE).
Measured: 3 months
To assess the relationship between patient-generated data gathered from smartphone and connected devices and patient reported functional status.
The prediction of reported outcome measures (CAT; EQ-5D; SGRQ-C) can also be addressed as a regression task, evaluated with RMSE, as detailed above.
Measured: 3 months
To assess the change in passively generated data at the time of further community intervention (HCP review and/or prescription for corticosteroids or antibiotics).
Acquired physiological and environmental data before and after community intervention will be compared using appropriate statistical tests to identify whether effects of these interventions were detectable in the acquired physiological data. We will also attempt to use machine learning models for the classification tasks of predicting corticosteroids, antibiotics, or HCP review outcome) using the physiological and environmental data in the time window prior to the specified community intervention outcome.
Measured: 3 months
To evaluate the usability and acceptability of patient-generated data gathered from smartphone and connected devices in a remote setting in patients with COPD.
Summary of the outcomes measured in the HCP mHealth app usability questionnaire (MAUQ) and other app analytics will be generated using standard summary statistics measures (mean/median, standard deviation, confidence intervals). This data will be assessed in relation to app and usage analytics such as compliance rate, drop-out rate, and device wear time.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start22 Sep 2023
- Primary completion19 Dec 2025
- Study completion24 May 2026
Why it stopped: Sponsor decision due to data collection concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118632
- Sponsor's protocol ID
- CW005
- Acronym
- SENSOR
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06118632
- Acronym / sponsor ID
- SENSOR / CW005
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision due to data collection concerns
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 7 Nov 2023 (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.
The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. This device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. This could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether.
The study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients admitted in hospital
Key inclusion criteria (4 listed)
- Aged 18 or over.
- Diagnosis of COPD, currently admitted to hospital and clinically stable with a confirmed acute exacerbation of COPD.
- Ownership of a smartphone (iOS version 13 or above, Android version 8 or above).
- Able to provide informed consent to participate in study.
Key exclusion criteria (5 listed)
- Patients who require less than 24 hours in hospital at initial visit.
- Patients deemed unlikely to cooperate with study requirements.
- Patients with implantable devices.
- Patient not felt to be suitable for research enrolment by admitting clinical team.
- Patients requiring non-invasive ventilation or deemed to have a life-expectancy of less than 90 days following discharge.
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 |
|---|---|---|
| ObservationalObservational | Other | – |
Primary outcome
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Total number of subjects: number of subjects who completed the on boarding stage of the study
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Dropout rate: proportion of subjects who dropped out (withdrew from study or stopped using the app/connected device prior to the off-boarding process or had to exit the trial due to deterioration)
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Median time to dropout, where time to dropout is the number of days between subject's enrolment date and drop-out date (either date of withdrawal/exit from the study or date when subject stopped using the app and connected device entirely)
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Number of participants who provided passive measurements for minimum of 50% of the study period
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Number of participants who provided minimum of 33% of measures requiring active input from user
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Data completeness: proportion of missing and total number of data points
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Data consistency across sources: where similar information is recorded in multiple modules (e.g., breathlessness scale and symptom tracker), proportion of records in which consistent answers were provided will be reported
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Proportion of data within admissible value range, where admissible value range will be determined based on literature or clinical guidance
To assess the volume and quality of the data collected in terms of:
Time frame: 3 months
Similarity of collected data distribution to expected data distribution, where expected data distribution will be determined based on literature and similarity of the two distributions evaluated by a suitable statistical technique (e.g., Kolmogorov-Smirnov test)
5 secondary outcomes
To ascertain whether marked physiological events can be detected using smartphone and connected device sensors in a remote setting.
Time frame: 3 months
To assess the relationship between patient-generated data gathered from smartphone and connected devices and conventional clinical measures at point of readmission.
Time frame: 3 months
To assess the relationship between patient-generated data gathered from smartphone and connected devices and patient reported functional status.
Time frame: 3 months
To assess the change in passively generated data at the time of further community intervention (HCP review and/or prescription for corticosteroids or antibiotics).
Time frame: 3 months
To evaluate the usability and acceptability of patient-generated data gathered from smartphone and connected devices in a remote setting in patients with COPD.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Sponsor decision due to data collection concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 Exacerbation, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 5 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 11 Aug 2026. 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 United Kingdom. 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 was stopped early (reason given: Sponsor decision due to data collection concerns). 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?
To assess the volume and quality of the data collected in terms of: (time frame: 3 months). 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 11 Aug 2026.