COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A (CSA)

May 16, 2024 updated by: Judith Garcia-Aymerich, Barcelona Institute for Global Health

COPD Exacerbation Modelling Study Using Daily-life Data From Unobtrusive Sensors - the TOLIFE Clinical Study A

This work is a multicentric prospective cohort study designed to improve chronic obstructive pulmonary disease (COPD) treatment and management. The study involves 150 patients diagnosed with COPD who are at risk of exacerbations. These patients are recruited from three tertiary hospitals in Spain, Germany, and Italy. The study will last 18 months, with a 12-month follow-up duration for each patient. The primary objective of this study is to develop and test Artificial Intelligence (AI)-based models that can predict moderate-to-severe COPD exacerbations early on. This will be done by analyzing daily-life data collected from unobtrusive sensors that monitor patients' psycho-physiological and environmental signals. By accurately predicting exacerbations, the study aims to support clinicians in providing more precise, optimized, and personalized treatment to COPD patients. A secondary objective is to train and test AI-based models to estimate the 12-month dynamics of health-related quality of life (HRQoL) in COPD patients. This will involve analyzing data related to the patients' functional exercise capacity, dyspnea (difficulty breathing), and health-related quality of life, as measured by the Clinical COPD Questionnaire (CCQ) score and the COPD Assessment Test (CAT) score.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927
        • Recruiting
        • Pulmonary Research Institute
        • Contact:
  • Italy
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study targets COPD patients at risk of moderate-to-severe exacerbations. Participants will be recruited from three European tertiary care hospitals: Hospital del Mar in Barcelona, Spain; the Pulmonary Research Institute in Grosshansdorf, Germany; and Azienda Ospedaliera Universitaria Pisana in Pisa, Italy. Recruitment sources include research registers, hospital records, and referrals.

Description

Inclusion Criteria:

  • Diagnosis of COPD (FEV1/FVC < 0.7) for at least a year.
  • Participants with moderate-to-very severe COPD (FEV1 ≤ 80% predicted)
  • Documented history of ≥ 1 moderate (treated with SABDs and oral corticosteroids ± antibiotics) or severe COPD exacerbation* within 12 months before enrolment.
  • Adults aged 40 or over.
  • Able to walk 4 meters independently with or without walking aids.
  • Anticipated availability for repeated study visits over 12 months.
  • Willingness to use smart sensors.
  • Able to read and write in the first language in the respective location.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the study protocol.

Exclusion Criteria:

  • Occurrence of any of the following within three months before informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD).
  • Uncontrolled congestive heart disease (NYHA class >3).
  • Having undergone major lung surgery (e.g., lung transplant)
  • Primary respiratory diseases other than COPD.
  • Participant who has experienced a major respiratory infection or exacerbation within 2 weeks before screening
  • Lung volume reduction within six months before screening.
  • Active treatment for cancer or other malignant diseases that in the opinion of the investigator, have an impact on the patient's quality of life such as to prevent adherence to the study.
  • Acute psychosis or major psychiatric disorders or continued substance abuse.
  • Severe disease that limits survival to 1 year.
  • Patients with severe cognitive impairment (MMSE < 18).
  • Substantial limitations in mobility due to factors other than COPD.
  • Inability to follow the study procedures (e.g., due to language problems, psychological disorders) or unable to read, understand and fill in a questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of moderate-to-severe COPD exacerbations
Time Frame: Months 3, 6, 9, and 12
Occurrence of moderate-to-severe COPD exacerbations at months 3, 6, 9, and 12, through medical records
Months 3, 6, 9, and 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the functional exercise capacity
Time Frame: Baseline, Month 3, 6, 9 and 12
Changes in the functional exercise capacity at baseline, month 3, 6, 9 and 12, as measured by the Six-minute walking distance
Baseline, Month 3, 6, 9 and 12
Changes in the health-related quality of life
Time Frame: Baseline, Month 3, 6, 9 and 12
Health-related quality of life at baseline, months 3, 6, 9, and 12, using the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The CCQ score ranges from 0 to 6, and the CAT score ranges from 0 to 40. Both questionnaires use higher scores to indicate a more severe impact of COPD on a patient's life.
Baseline, Month 3, 6, 9 and 12
Changes in the dyspnoea severity grade
Time Frame: Baseline, Month 3, 6, 9 and 12
Changes in the dyspnoea severity grade at baseline, month 3, 6, 9, and 12, as measured by the modified Medical Research Council (MRC) Dyspnoea scale. The mMRC Dyspnoea scale ranges from 0 to 4, with higher scores indicating more severe dyspnea.
Baseline, Month 3, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barcelona Institute for Global Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pisa
Universidad Politecnica de Madrid
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
LungenClinic Grosshansdorf
Hospital del Mar Research Institute
Avvale
TIMELEX

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Judith Garcia-Aymerich, Barcelona Institute for Global Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 101057103CSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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