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TARA Working Prototype [Version 2]: Feasibility Study

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Technology-Assisted Respimat Adherence 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 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Assessment of motivation and perception

Qualitative assessment of data sourced through the prototype and via discussion in the exit interview

Secondary Outcome Measures

Percent of individuals with COPD who achieve improvements in intention (Readiness for Change) measured by the Readiness for Change Questionnaire

Percent of individuals with COPD who achieve improvements in autonomous motivation measured by the Treatment Self-Regulation Questionnaire (TSRQ)

Percent of individuals with COPD who achieve confidence measured by the Perceived Competence Scale; PCS)

Percent of participants who increased adherence to once daily inhaled medication, based on Test of Adherence to Inhalers (TAI) Questionnaire

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 ?"

Percent of participants who report increases in adherence to once daily inhaled medication, based on prescription re-fill confirmation

Percent of participants who report increases in adherence to once daily inhaled medication, based on TARA daily check-in data.

Percent of study participants who report a reduction in COPD symptoms measured via the COPD Assessment test (CAT)

Full Information

NCT ID

NCT04320524

First Posted

March 15, 2020

Last Updated

November 19, 2020

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04320524

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Due to Covid, the study could not be initiated as planned.

Study Start Date

February 17, 2021 (Anticipated)

Primary Completion Date

July 12, 2021 (Anticipated)

Study Completion Date

September 6, 2021 (Anticipated)

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 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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All subjects

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention

Intervention Description

3 weeks

Primary Outcome Measure Information:

Title

Patient interaction with TARA (engagement via usage data)

Description

Time Frame

up to 3 weeks

Title

Assessment of usability issues

Description

Time Frame

up to 3 weeks

Title

Assessment of motivation and perception

Description

Qualitative assessment of data sourced through the prototype and via discussion in the exit interview

Time Frame

up to 3 weeks

Secondary Outcome Measure Information:

Title

Percent of individuals with COPD who achieve improvements in intention (Readiness for Change) measured by the Readiness for Change Questionnaire

Time Frame

up to 3 weeks

Title

Percent of individuals with COPD who achieve improvements in autonomous motivation measured by the Treatment Self-Regulation Questionnaire (TSRQ)

Time Frame

up to 3 weeks

Title

Percent of individuals with COPD who achieve confidence measured by the Perceived Competence Scale; PCS)

Time Frame

up to 3 weeks

Title

Percent of participants who increased adherence to once daily inhaled medication, based on Test of Adherence to Inhalers (TAI) Questionnaire

Time Frame

up to 3 weeks

Title

Percent of participants who report increases in adherence to once daily inhaled medication, based on study-specific medication adherence question

Description

Medication adherence question: "During the last 7 days, how many times did you forget to take your daily inhaler ?"

Time Frame

up to 3 weeks

Title

Percent of participants who report increases in adherence to once daily inhaled medication, based on prescription re-fill confirmation

Time Frame

up to 3 weeks

Title

Percent of participants who report increases in adherence to once daily inhaled medication, based on TARA daily check-in data.

Time Frame

up to 3 weeks

Title

Percent of study participants who report a reduction in COPD symptoms measured via the COPD Assessment test (CAT)

Time Frame

up to 3 weeks

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 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

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 [Version 2]: Feasibility Study

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