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TARA Working Prototype Engagement Evaluation: Feasibility Study

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Digital Behaviour Change Intervention

About this trial

This is an interventional device feasibility trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Further exclusion criteria apply

Sites / Locations

Medullan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

Outcomes

Primary Outcome Measures

% of study participants achieving 80% or higher engagement score with their personal TARA program

Study participant's motivation to engage with the TARA working prototype (version 1) and their perceptions of value and usefulness

Qualitative assessment of motivation and perceptions of value and usefulness at different stages in the participant's journey through the prototype; data sourced via discussion in an exit interview at the end of the study.

Evidence of usability issues, patterns of dis-engagement or failures of use in particular pages or functional areas of the prototype

Analysis of usage data of the site to explore if there are common points at which participants fail to progress, make mistakes or abandon interactions; Data will be sourced from individual and amalgamated usage analytics - data points will include drop-out rates for each of the main functional areas of the site and will be supplemented by within-page usage data An overall score for perceived ease-of-use will be generated using the 'System Usability Scale' (SUS), using self-reported data from the pre- and post-TARA participant questionnaire

Study participant's reports of usability or other issues from using the prototype

Secondary Outcome Measures

% of study participants who achieve a score of 8 or greater in Knowledge, Motivation, Confidence (KMC) assessments

% of study participants who achieve a positive change in measures of motivation, activation, competence (self-efficacy) and stage of change

% of study participants who report increases in adherence to once daily inhaled medication and reduction in Chronic Obstructive Pulmonary Disease (COPD) symptoms

Full Information

NCT ID

NCT04085302

First Posted

September 3, 2019

Last Updated

September 10, 2020

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04085302

Brief Title

TARA Working Prototype Engagement Evaluation: Feasibility Study

Official Title

Mixed Methods (Quantitative, Qualitative) Feasability Study Assessing Engagement With the First Version of the TARA Working Prototype (a Digital Behaviour Change Intervention, DBCI) in Individuals With COPD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

September 26, 2019 (Actual)

Primary Completion Date

December 3, 2019 (Actual)

Study Completion Date

December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All subjects

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Digital Behaviour Change Intervention

Intervention Description

14 days

Primary Outcome Measure Information:

Title

% of study participants achieving 80% or higher engagement score with their personal TARA program

Time Frame

Up to 14 days

Title

Study participant's motivation to engage with the TARA working prototype (version 1) and their perceptions of value and usefulness

Description

Time Frame

Up to 14 days

Title

Evidence of usability issues, patterns of dis-engagement or failures of use in particular pages or functional areas of the prototype

Description

Time Frame

Up to 14 days

Title

Study participant's reports of usability or other issues from using the prototype

Time Frame

Up to 14 days

Secondary Outcome Measure Information:

Title

% of study participants who achieve a score of 8 or greater in Knowledge, Motivation, Confidence (KMC) assessments

Time Frame

Up to 14 days

Title

% of study participants who achieve a positive change in measures of motivation, activation, competence (self-efficacy) and stage of change

Time Frame

Up to 14 days

Title

% of study participants who report increases in adherence to once daily inhaled medication and reduction in Chronic Obstructive Pulmonary Disease (COPD) symptoms

Time Frame

Up to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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 Further exclusion criteria apply

Facility Information:

Facility Name

Medullan

City

Somerville

State/Province

Massachusetts

ZIP/Postal Code

02144

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Learn more about this trial

TARA Working Prototype Engagement Evaluation: Feasibility Study

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