Status:
COMPLETED
TARA Working Prototype Engagement Evaluation: 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 Chronic Obstructive Pulmonary Disease (COPD)(IwCOPD), which has been designed using a Human-Centred Design (HCD) methodology...
Eligibility Criteria
Inclusion
- 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
- 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
- Further exclusion criteria apply
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04085302
Start Date
September 26 2019
End Date
December 3 2019
Last Update
September 11 2020
Active Locations (1)
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1
Medullan
Somerville, Massachusetts, United States, 02144