Clinical trial NCT04320524: TARA Working Prototype [Version 2]: Feasibility Study
Official title: Mixed Methods (Quantitative, Qualitative) Feasability Study Assessing Engagement With the TARA Working Prototype [Version 2] (a Digital Behaviour Change Intervention, DBCI) and Effects of TARA on Behavioural Targets and Medication Adherence in Individuals With COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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, 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.


Eligibility 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

Primary outcomes:
measure: Patient interaction with TARA (engagement via usage data)
timeFrame: up to 3 weeks
measure: Assessment of usability issues
timeFrame: up to 3 weeks
measure: Assessment of motivation and perception
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Percent of individuals with COPD who achieve improvements in intention (Readiness for Change) measured by the Readiness for Change Questionnaire
timeFrame: up to 3 weeks
measure: Percent of individuals with COPD who achieve improvements in autonomous motivation measured by the Treatment Self-Regulation Questionnaire (TSRQ)
timeFrame: up to 3 weeks
measure: Percent of individuals with COPD who achieve confidence measured by the Perceived Competence Scale; PCS)
timeFrame: up to 3 weeks
measure: Percent of participants who increased adherence to once daily inhaled medication, based on Test of Adherence to Inhalers (TAI) Questionnaire
timeFrame: up to 3 weeks
measure: Percent of participants who report increases in adherence to once daily inhaled medication, based on study-specific medication adherence question
timeFrame: up to 3 weeks
measure: Percent of participants who report increases in adherence to once daily inhaled medication, based on prescription re-fill confirmation
timeFrame: up to 3 weeks
measure: Percent of participants who report increases in adherence to once daily inhaled medication, based on TARA daily check-in data.
timeFrame: up to 3 weeks
measure: Percent of study participants who report a reduction in COPD symptoms measured via the COPD Assessment test (CAT)
timeFrame: up to 3 weeks
Other outcomes:
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