TerminatedNot Applicable

Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease

Stopped: Sponsor decision due to data collection concerns

United Kingdom131 participantsStarted 2023-09-22

Plain-language 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. 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.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

Trial details

NCT IDNCT06118632

SponsorChelsea and Westminster NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-19

View on ClinicalTrials.gov More COPD Exacerbation trials

Plain-language summary

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months

To assess the volume and quality of the data collected in terms of:

Timeframe: 3 months