Clinical trial NCT06118632: Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
Official title: Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD Exacerbation
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients admitted in hospital

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
measure: To assess the volume and quality of the data collected in terms of:
timeFrame: 3 months
Secondary outcomes:
measure: To ascertain whether marked physiological events can be detected using smartphone and connected device sensors in a remote setting.
timeFrame: 3 months
measure: To assess the relationship between patient-generated data gathered from smartphone and connected devices and conventional clinical measures at point of readmission.
timeFrame: 3 months
measure: To assess the relationship between patient-generated data gathered from smartphone and connected devices and patient reported functional status.
timeFrame: 3 months
measure: To assess the change in passively generated data at the time of further community intervention (HCP review and/or prescription for corticosteroids or antibiotics).
timeFrame: 3 months
measure: To evaluate the usability and acceptability of patient-generated data gathered from smartphone and connected devices in a remote setting in patients with COPD.
timeFrame: 3 months
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Stoke Mandeville Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
Study officials:
References: