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TARA Working Prototype Engagement Evaluation: Feasibility Study

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ClinicalTrials.gov Identifier: NCT04085302
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Digital Behaviour Change Intervention Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 26, 2019
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : December 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arm Intervention/treatment
Experimental: All subjects Behavioral: Digital Behaviour Change Intervention
14 days




Primary Outcome Measures :
  1. % of study participants achieving 80% or higher engagement score with their personal TARA program [ Time Frame: Up to 14 days ]
  2. Study participant's motivation to engage with the TARA working prototype (version 1) and their perceptions of value and usefulness [ Time Frame: Up to 14 days ]
    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.

  3. Evidence of usability issues, patterns of dis-engagement or failures of use in particular pages or functional areas of the prototype [ Time Frame: Up to 14 days ]
    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

  4. Study participant's reports of usability or other issues from using the prototype [ Time Frame: Up to 14 days ]

Secondary Outcome Measures :
  1. % of study participants who achieve a score of 8 or greater in Knowledge, Motivation, Confidence (KMC) assessments [ Time Frame: Up to 14 days ]
  2. % 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 ]
  3. % 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085302


Locations
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United States, Massachusetts
Medullan
Somerville, Massachusetts, United States, 02144
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04085302    
Other Study ID Numbers: 0352-2133
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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/


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive