TARA Working Prototype Engagement Evaluation: Feasibility Study

NCT ID: NCT04085302

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2019-12-03

Brief Summary

TARA is a Digital Behaviour Change Intervention (DBCI) for individuals with Chronic Obstructive Pulmonary Disease (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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

All subjects

Group Type: EXPERIMENTAL

Digital Behaviour Change Intervention

Intervention Type: DEVICE

14 days

Interventions

Digital Behaviour Change Intervention

14 days

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medullan

Somerville, Massachusetts, United States

Countries

United States

Other Identifiers

0352-2133

Identifier Type: -

Identifier Source: org_study_id