TARA Working Prototype [Version 2]: Feasibility Study

Boehringer Ingelheim

Status

Withdrawn

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Device: Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT04320524

0352-2134

Details and patient eligibility

About

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, members of the target audience in evaluations at multiple stages within the design process.

This feasibility study is primarily designed to assess the acceptability of the DBCI test asset to the target audience. Acceptability as defined for the purpose of this study includes usability of the system, and perceived value and desirability to the end-user audience. As such, engagement in this context is deemed to mean the degree to which the test asset provides a usable, acceptable, desirable and valuable experience to its users during a time-limited trial.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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 Criteria:

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