Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04085302
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated written electronic informed consent (e-consent) in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the study
* Male or female patients
* All patients must have a self-reported confirmation of a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD)(or chronic bronchitis or emphysema)
* Age ≥ 40 years
* Patients must be current or ex-smokers with a smoking history of at least 10 pack-years (pack years = \[cigarettes per day/20\] x years of smoking)
* Modified Medical Research Council (mMRC) Score ≥ 1 (i.e. evidence of activity-related breathlessness)
* Patients must have a current prescription for once daily maintenance bronchodilator in keeping with their approved labels as well as a short-acting bronchodilator ("rescue medication") for at least 3 months prior to study enrolment
* Participants must be willing to use a smart watch and be willing to complete all data collection requirements (within TARA plus phone interview plus on-line questionnaires)
* Patients must confirm that his/her treating physician has been informed about the patient's participation in the study (prior to TARA log-in)
* Fluency in written English
* Currently residing in US (for duration of study)
* Not fully adherent (self-report) to once daily inhaled COPD medication (\<80% on a protocol-specific participant self-assessment scale of medication adherence (0 - 100%))
* Access to (and comfort with) a digital device (Desktop; Laptop; Tablet), with updated Firefox \[version 67.0 and above\] or Chrome \[version 75.0.3770.80 and above\] browsers installed (or willing to download up-to-date version for the study), and daily home access to internet
* Need to have personal e-mail account that is used daily
Exclusion Criteria:
* Patients with asthma
* Patients who are currently prescribed oxygen therapy
* Patients who have completed a pulmonary rehabilitation (PR) program in the 6 weeks prior to enrolment or patients who are currently in a PR program (rationale: PR programs typically include a self-management component which may interfere with study objectives)
* Planned vacation period during the study period that requires overnight stays away from home
* Major surgery performed within 6 weeks prior to enrolment or planned within 2 months after enrolment, e.g. hip replacement
* Previous enrolment in this study
* Currently enrolled in another investigational device or drug study/trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Current use of a Smartwatch and/or wrist-worn step counter and not willing to switch to the study-specific Smartwatch for the duration of study
* Any medical or neuro-cognitive condition that would limit the ability of the participant to consent
* Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04085302
Study Brief:
Protocol Section:
NCT04085302