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Pulmonary Disease, Chronic ObstructiveNCT04320524

TARA Working Prototype [Version 2]: Feasibility Study

A study testing Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
17 Feb 2021to 6 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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

About this 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

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.

Being tested
Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology-Assisted Respimat Adherence Digital Behaviour Change InterventionDevice

    3 weeks

Study groups in NCT04320524
Study groupRoleWhat they receive
All subjectsExperimentalNot described
Receives: Device: Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 3 weeks

  2. 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.

    Measured: up to 3 weeks

  3. Assessment of motivation and perception

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

    Measured: up to 3 weeks

Secondary outcomes (8)

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

    Measured: up to 3 weeks

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

    Measured: up to 3 weeks

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

    Measured: up to 3 weeks

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

    Measured: up to 3 weeks

  5. 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 ?"

    Measured: up to 3 weeks

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

    Measured: up to 3 weeks

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

    Measured: up to 3 weeks

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

    Measured: up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start17 Feb 2021 (estimated)
  3. Primary completion12 Jul 2021 (estimated)
  4. Study completion6 Sep 2021 (estimated)

Why it stopped: Due to Covid, the study could not be initiated as planned.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04320524
Sponsor's protocol ID
0352-2134
Status last verified
Nov 2020
First submitted
15 Mar 2020
Last updated
23 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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/

Questions about this trial

What is this clinical trial studying?

A study testing Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient interaction with TARA (engagement via usage data) (time frame: up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04320524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

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TARA Working Prototype [Version 2]: Feasibility Study | AzTrials