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

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: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Variations in daily life activity signals detected by unobtrusive sensors

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Judith Garcia-Aymerich, MD; PhD; Phone Number: +342147380; Email: judith.garcia@isglobal.org

Study Locations

• Germany
  • Schleswig-Holstein
    • Großhansdorf, Schleswig-Holstein, Germany, 22927
      • Recruiting
      • Pulmonary Research Institute
      • Contact: Henrik Watz; Phone Number: +4941028881111; Email: H.Watz@pulmoresearch.de
• Italy
  • Pisa, Italy, 56126
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria Pisana
    • Contact: Alessandro Celi; Phone Number: +39050995236; Email: alessandro.celi@unipi.it
• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar Research Institute
    • Contact: Joaquim Gea; Phone Number: +34618175694; Email: jgea@psmar.cat

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of moderate-to-severe COPD exacerbations	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

Outcome Measure	Measure Description	Time Frame
Changes in the functional exercise capacity	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	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	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

• Sponsor: Barcelona Institute for Global Health
• Collaborators: 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: Principal Investigator: Judith Garcia-Aymerich, Barcelona Institute for Global Health

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Exacerbation; Chronic Obstructive Pulmonary Disease (COPD); Remote patient monitoring; Predictive modeling
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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