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

NCT06118632 | Unknown

• 1 other identifier: CW005
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (9)

• 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

  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)

  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)

  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

  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

  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

  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

  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

  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)

  3 months

Secondary Outcomes (5)

• To ascertain whether marked physiological events can be detected using smartphone and connected device sensors in a remote setting.

  3 months

• To assess the relationship between patient-generated data gathered from smartphone and connected devices and conventional clinical measures at point of readmission.

  3 months

• To assess the relationship between patient-generated data gathered from smartphone and connected devices and patient reported functional status.

  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).

  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.

  3 months

Interventions

Observational OTHER

Observational

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients admitted in hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (4)

Stoke Mandeville Hospital

Aylesbury, United Kingdom

RECRUITING

Royal Sussex County Hospital

Brighton, United Kingdom

RECRUITING

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 0XD, United Kingdom

RECRUITING

Nottingham University Hospitals

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Arnold Xhikola

CONTACT

00442033152560; arnold.xhikola1@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: November 7, 2023
• Study Start: September 22, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

GB (4)