Status:
WITHDRAWN
TARA Working Prototype [Version 2]: Feasibility Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
TARA is a Digital Behaviour Change Intervention (DBCI) for Individuals with COPD (IwCOPD), which has been designed using a Human-Centred Design (HCD) methodology. HCD involves, among other elements, m...
Eligibility Criteria
Inclusion
- Signed and dated written electronic informed consent (e-consent) in accordance with 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 COPD (or chronic bronchitis or emphysema)
- Age ≥ 40 years
- Patients must be current or ex-smokers
- Modified Medical Research Council (mMRC) Score ≥ 2 (i.e. evidence of activity-related breathlessness)
- Patients must have a current prescription for either Spiriva Respimat or Stiolto Respimat 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 their treating physician has been informed about their participation in the study (prior to TARA log-in)
- Fluency in written English
- Currently residing in US (for duration of study)
- Participants should be not fully adherent to once daily inhaled COPD medication (as measured with a score of 2 or greater on a protocol-specific participant self-assessment scale of forgetting to take the medication in the last 7 days)
- Access to (and comfort with) a digital device (Desktop; Laptop; Tablet), with updated Firefox or Chrome 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
- Key
Exclusion
- Patients with asthma
- Patient with a worsening COPD episode requiring medical intervention within 4 weeks of enrolment
- Patients who have completed a pulmonary rehabilitation (PR) program in the 6 months 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
- Patients prescribed inhaled COPD medications other than Spiriva Respimat plus albuterol or Stiolto Respimat plus albuterol
- Previous enrolment in study 352.2133
- Previous enrolment in this study Further exclusion criteria apply
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04320524
Start Date
February 17 2021
End Date
September 6 2021
Last Update
November 23 2020
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