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

NCT ID: NCT06118632

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-22

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational

Observational

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stoke Mandeville Hospital

Aylesbury, , United Kingdom

Site Status RECRUITING

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status RECRUITING

Chelsea and Westminster Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Nottingham University Hospitals

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Arnold Xhikola

Role: CONTACT

00442033152560

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Donna Chabanne

Role: primary

Cielito Caneja

Role: primary

Rogie M Delos-santos

Role: primary

Savini Pathirana

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CW005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cough Monitoring in COPD
NCT07098793 COMPLETED