TARA Working Prototype [Version 2]: Feasibility Study

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Device: Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br> | Device: Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention<br>* 3 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient interaction with TARA (engagement via usage data) | Data sourced from individual and amalgamated usage analytics. Data points collected from TARA Patient database / usage analytics, recording the completion with time and date stamps by the users of key sections of the TARA program. An overall score for perceived ease-of-use will be generated using the System Usability Scale (SUS) participant questionnaire | up to 3 weeks | 
| Assessment of usability issues | Qualitative assessment of participant's feedback on any usability issues, areas of confusion or lack of clarity whilst using TARA working prototype (version 2). Data sourced from participant's reports, emails and exit interviews. | up to 3 weeks | 
| Assessment of motivation and perception | Qualitative assessment of data sourced through the prototype and via discussion in the exit interview | up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of individuals with COPD who achieve improvements in intention (Readiness for Change) measured by the Readiness for Change Questionnaire |  | up to 3 weeks | 
| Percent of individuals with COPD who achieve improvements in autonomous motivation measured by the Treatment Self-Regulation Questionnaire (TSRQ) |  | up to 3 weeks | 
| Percent of individuals with COPD who achieve confidence measured by the Perceived Competence Scale; PCS) |  | up to 3 weeks | 
| Percent of participants who increased adherence to once daily inhaled medication, based on Test of Adherence to Inhalers (TAI) Questionnaire |  | up to 3 weeks | 
| Percent of participants who report increases in adherence to once daily inhaled medication, based on study-specific medication adherence question | Medication adherence question: During the last 7 days, how many times did you forget to take your daily inhaler ? | up to 3 weeks | 
| Percent of participants who report increases in adherence to once daily inhaled medication, based on prescription re-fill confirmation |  | up to 3 weeks | 
| Percent of participants who report increases in adherence to once daily inhaled medication, based on TARA daily check-in data. |  | up to 3 weeks | 
| Percent of study participants who report a reduction in COPD symptoms measured via the COPD Assessment test (CAT) |  | up to 3 weeks |